HS Code Classification Orthopaedic Fracture Appliances: Customs Tax Consultant Kenya

In your submission you state: “The ‘Aspen Spinous Process System’ from Lanx Inc., is a posterior, non-pedicle fixation device for single level placement in surgical surgeries for the human spine. It is designed for plate attachment to the spinous processes to achieve supplemental fusion in patients who suffer from degenerative disc disease, spondylolisthesis, trauma and or tumor. The biocompatible FDA approved 3 part titanium assembly is intended for the sole use for surgical implantation.”

You also state: “The Surgical Instrument Case hereby called a Set, includes multiple instruments for implantation of the Aspen assembly and is comprised of ALL-Medical Grade Stainless Steel within a Stainless Steel Case.”

From the brochure pages you provided, the instruments in the surgical set are mostly manual instruments which resemble specialized tweezers, forceps, and torque screwdrivers put together for use by the orthopedic surgeon in implanting the vertebral support.

We agree that the applicable subheading for the Aspen implants will be 9021.10.0050, Harmonized Tariff Schedule of the United States (HTSUS), which provides for Orthopedic and fracture appliances, which are Bone plates, screws and nails, and other internal fixation devices or appliances. We agree that the applicable subheading for the Aspen instrument set, imported separately, will be 9018.90.8000, Harmonized Tariff Schedule of the United States (HTSUS), which provides for “other” instruments and apparatus used in medical, surgical, dental, or veterinary sciences, and parts and accessories thereof.

In your letter, you state that the sample Medical Shoe “would be sold as half pairs to be used/worn after surgery.” Consistent with that statement, the sample curves neither left nor right, but would fit either foot equally. Its outer sole is extremely rigid, which effectively immobilizes an injured or post-surgery foot from bending while walking, although making ordinary walking more difficult. Also, the upper is absent in the first third of the shoe and has long straps which are very adjustable, both useful for those with a thickly bandaged foot.

Note 6 to Chapter 90, Harmonized Tariff Schedule of the United States, HTSUS, states: Orthopedic appliances include footwear and special insoles designed to correct orthopedic conditions, provided that they are either (1) made to measure or (2) mass-produced, entered singly and not in pairs and designed to fit either foot equally.

You propose classification in 9021.90.81, HTSUS. However, it is not “other than” an orthopedic or fracture appliance

The applicable subheading for Medical Shoe will be 9021.10.0090 , HTSUS, which provides for “other” Orthopedic or fracture appliances, and parts and accessories thereof.

Sample 6062, is a back support belt. It is constructed of knit elastic fabric with six vertical plastic stays. The belt measures approximately 38 inches by 9 inches at its widest point and tapers to 4-1/2 inches at either end. Each tapered end section has a book and loop fastener.

The applicable subheading for item number 6062 will be 6307.90.9889, Harmonized Tariff Schedule of the United States (HTS), which provides for other made up articles Other.

Sample 6933, Wrist Brace, size medium, has an S shaped, rigid, metal splint which is about 1.5 inches wide and 6 inches long which will be under the hand. When the velcro-like straps are closed, the wearer’s wrist will be essentially immobilized even though the stretched, elastic base material will still provide a very limited amount of stretch. The metal splint is removable, but it is a substantial portion of the weight of the complete item. Its characteristics are primarily consistent with purchase for use to support or hold the wrist following an illness, operation or injury (Note 6 to HTS Chapter 90.)

Sample 6948, Hernia Aid, size small, has a textile belt with a small amount of stretch to go around the waist and two textile elastic straps that will go around the upper thighs. The belt has a flap with a curved “teardrop” of almost rigid rubber or plastics which is about 4 inches long, 2.5 inches wide and .7 inches thick at its thickest. Inguinal trusses are cited in Explanatory Note I-10 to Harmonized System Heading 90.21.

The applicable subheading for the 6933 & 6948 will be 9021.10.0090, Harmonized Tariff Schedule of the United States (HTS), which provides for orthopedic appliances, including crutches, surgical belts and trusses; splints and other fracture appliances.

In your letter dated February 4, 2002, for MGRM Medicare Limited, you requested a tariff classification ruling. Each sample is packed in a poly bag imprinted “MGRM.”

The Spondylosis Collar, M, 0101, is, on average, about 5 inches high. It is shaped to closely encircle the neck with a semi-rigid, molded plastic. It has an opening in the front for the Adam’s apple. It is held in place by a strap of velcro-like material which encircles the neck. The Arm Sling Pouch Deluxe, 0206, has a fabric envelope and a strap of a velco-like material, which goes around the other side of the wearer’s neck. It holds the arm in place, bent at a right angle, against the body. Its indications include for arm fractures. The RS Brace, Left, L, 0308, is about 13 inches long. It encircles the forearm and has three rigid splints. It is tightened using several straps of velcro-like material. Its purpose is to prevent the forearm from bending, which is possible when it is fractured. The principal indication is for distal forearm fractures. The Dorsolumbar Spinal Brace, L, 0512, goes from the wearer’s waist at the back to the neck. It is about 22 inches tall. It has two non-removable, metal, rigid, S-shaped, braces that go its full length. These make it virtually impossible for the wearer to bend at the waist. There is also a less rigid metal brace that encircles the rear part of the wearer’s waist. It is covered with textile and is secured by both elastic and non-elastic thoracic and clavicle straps made of textile, with and without velcro-like materials. Its indications include for herniated discs. The Knee Immobiliser, L, 0702, is about 22 inches tall. It has three, mildly S-shaped, rigid stays, which make it virtually impossible for the wearer to bend the leg at the knee more than 10-15 degrees, if at all, thereby noticeably inhibiting walking at more than a very slow pace. The body is made of padded textile. It is secured by 8 non-elastic, textile straps using velcro-like materials. Its indications include fracture dislocations. The Ankle Support, 0802, is made of two concave pieces of rigid, molded plastic, about 9 inches by 4 inches, with a semi-rigid, plastic, foam padding. It is held in place by two non-elastic straps, including velcro-like materials, which will encircle the leg above the ankle, and a textile strap with a foam pad that goes under the front of the heel. It is designed to not immobilize the normal flexing of the ankle joint to move the foot up and down. In fact, it causes virtually no interference with that motion. The catalog you sent states: “Indicated For –- Protection of ankle joint against sprains in sports and during normal activities –- Post-operative rehabilitation.”

Regarding the ankle support, we note that lateral forces on the ankle are quite rare in normal activities, although quite common in running field sports such as soccer. The amount of lateral support supplied appears to be comparable to that supplied by a properly applied “Ace” bandage ankle support. The rigid plastic, together with its padding, will provide considerable protection to the otherwise exposed ankle bone from the bumps and falling or flying objects which occur occasionally in both ordinary life and in sports.

Per Note 1-k excludes the articles of HTS Chapter 95, including sports equipment, from HTS Chapter 90.

However, although heading 9506, HTSUS, provides for articles and equipment for gymnastics, athletics, other sports and outdoor games, the Explanatory Notes to Heading 9506 state in pertinent part:

“This heading covers:

(B) (13) Protective equipment for sports or games, e.g., fencing masks, breast plates, elbow and kneepads, cricket pads, shin-guards.”

The sports protective equipment intended for inclusion within Heading 9506, HTSUS, recognizes only that equipment which is designed exclusively for protection against injury, that is, equipment having protective features with the sole or primary function of directly absorbing the impact of blows, collisions or flying objects. See HQ 965238. Thus, for example, in NY 862972 dated May 31, 1991, a padded shin guard, specially designed to protect against leg blows in the game of soccer and an elbow support which primarily provides protection against blows or falls qualify for classification in Heading 9506, but a hinged knee support and a back support were excluded form Heading 9506 because neither of these items have as their sole or primary function to directly absorb the impact of blows, collisions or flying objects.

The article, termed an “ankle support,” is described as a supporting device “specially designed for providing lateral support to the ankle while allowing free flexion movement.” It is not described as a “ pad” or “guard” and it is not designed with the sole or primary function of directly absorbing the impact of blows, collisions or flying objects that occur in sport or outdoor game play. Consequently, it is something different from the pads and guards described in the Heading 9506 Explanatory Notes. Because the ankle support does not serve primarily as a protective device against impacts imposed by blows, collisions or flying objects, it is not classifiable in Heading 9506, HTSUS

Sports use for a joint support is an indication that 9021 does not apply consistent with the Headquarters Ruling Letters published in the Customs Bulletin of December 19, 2001. Those rulings also note that textile joints supports are cited in EN 27 to HS heading 6307, Other made-up textile articles

The applicable subheading for the first five samples will be 9021.10.0090, Harmonized Tariff Schedule of the United States (HTS), which provides for orthopedic appliances, including crutches, surgical belts and trusses; splints and other fracture appliances.

The ankle support, 0802, is classifiable in subheading 3926.90.9880, HTS, which provides for other articles of plastics, other.

The Infiniti 500 Rollator, with wire basket, and the Folding Walker, Model 4000, are both designed to assist those with difficulty in walking by providing something to lean forward against. New York Ruling Letter G88041 noted.

The aluminum Quad Cane (with four legs), Model 3310, is height adjustable and has an anatomical handle.

The Raised Toilet Seat, Model 1645 is 5” in height, has front locking mounting mechanism, comfortable padded arm supports and a weight capacity of 300 lbs.

The Shower Seat, Model 1465 has a plastic seat with a metal frame made of aluminum tubing and a weight capacity of 250 lbs.

The applicable subheading for the Rollator and the Folding Walker will be 9021.10.0090, Harmonized Tariff Schedule of the United States (HTS), which provides for orthopedic appliances, including crutches, surgical belts and trusses; splints and other fracture appliances.

The applicable subheading for the Quad Cane will be 6602.00.0000, Harmonized Tariff Schedule of the United States (HTS), which provides for walking-sticks, seat sticks, whips, riding-crops and the like.

The applicable subheading for the Raised Toilet Seat will be 3922.20.0000, Harmonized Tariff Schedule of the United States (HTS), which provides for baths, shower baths, wash basins, bidets, lavatory pans, seats and covers, flushing cisterns and similar sanitary ware, of plastics, lavatory seats and covers.

The applicable subheading for the Shower Seat will be 9402.90.0020, Harmonized Tariff Schedule of the United States (HTS), which provides for medical, surgical, dental or veterinary furniture, other.

The 7528D, the Single Axis Shoe Insert, Large Right, is made of plastics. One piece cups the back, bottom, and sides of the wearer’s heel. Two 6 inch long pieces form are attached to the cup by hinges so that they can be moved forward and back. Each widens to 4 inches near their top, which as a 1.2 inch hole in it and dozens of short spikes projecting outward. It has a velcro-like strap across the instep. It is used in conjunction with an ankle cast to provide addition support.

The 7222D, Functional Position Hand Splint, Small Left, has a main body of padded, molded, rigid plastic, which is 12 inches long and is curved to hold the hand in a moderately curved position. There are three velcro-like straps along its length. The import should be fitted by a health care professional since it can be heated with a heat gun and reshaped to accommodate the individual patient. It is clearly intended to immobilize the hand and wrist following a serious injury or surgery, Note 6-b to HTS Chapter 90.

The 7127D, Femoral Casting Brim, Medium Right, is of molded plastic, about 4 to 6 inches high and 21 inches in circumference. As we understand your information, it is used by the doctor or other professional to shape the patient’s plaster cast before it dries hard.

We agree that the applicable subheading for the 7528D and 7222D will be 9021.10.0090, Harmonized Tariff Schedule of the United States (HTS), which provides for orthopedic appliances, including crutches, surgical belts and trusses; splints and other fracture appliances.

We agree that the applicable subheading for the 7127D will be 9018.90.8000, Harmonized Tariff Schedule of the United States (HTS), which provides for “other” instruments and appliances used in medical, surgical, dental or veterinary sciences.

The import, Ultimate Arm Sling by Joslin Orthopedic Gear, has non-stretching velcro-like straps which, in conjunction a base material with some lycra for limited stretch, will hold the arm, bent at a right angle in place against the wearer’s chest. Although the packaging indicates that one possible use would be for “arm fatigue,” it is essentially just a little more stretchy and more comfortable than a traditional arm sling, and its normal use would clearly be to hold the arm in place following an illness, operation or surgery as indicated in Note 6-b to HTS Chapter 90.

We agree that he applicable subheading for the sling will be 9021.10.0090, Harmonized Tariff Schedule of the United States (HTS), which provides for orthopedic appliances, including crutches, surgical belts and trusses; splints and other fracture appliances.

The package of the sample VelcoPedic, model 2200, adult, Lemmco Elbow Immobilizer states, “For Use When Elbow Must Not Bend.” The item consists of two, quite thick, aluminum rods which are about 11 inches wide and .5 inches wide. The are lightly shaped to follow the curve of the arm and have two slots for a velcro strap at one end and an adjustable plastic strap at the other.

You note the Notice regarding knee braces published in the Customs Bulletin of December 19, 2001. Although the HRLs do classify knee “immobilizers” in HTS 6307, those were mostly textile and, more important, clearly did not prevent the knee from bending, but only provided a limited amount of support for the muscles and/or ligaments when the knee is bent in normal running or walking. This item’s normal use would clearly be to hold the arm rigid following an illness, operation or surgery as indicated in Note 6-b to HTS Chapter 90.

The applicable subheading for the VelcroPedic will be 9021.10.0090, Harmonized Tariff Schedule of the United States (HTS), which provides for orthopedic appliances, including crutches, surgical belts and trusses; splints and other fracture appliances.

You stated FMS 4190, Interface Cable, and FMS 4503, Irrigation, are re-submissions of items returned to you for further information. You enclosed a copy of NYRL H89325-105, 4-3-02.

The interface cable, FMS Ref. 4190, consists of an insulated electric cable with connectors at each end. It is used between a foot control and an arthroscopic fluid management device.

You state that the sample FMS 4503 is a “Tube used to bring water to the surgical site during arthroscopic surgery.” The sample is in a sterile plastic bag, and consists of several lengths of plastic piping joined to each other and to a cylindrical plastic bottle with volume markings via various fittings. It is used in conjunction with electrical pumping devices, but it is medical apparatus in itself, noting especially Headquarters Ruling Letter 958098 KCC, 12-1-95. You propose classification in HTS 9018.19.95, but its function is essentially active, not diagnostic.

The 4-way Foot Pedal, FMS Ref. 4176, is used to control the pressure and flow of the arthroscopic fluid management device.

You state that the sample FMS 7510, Shaver Blade, is a “Metal stainless steel tube to cut soft tissue in cavity during surgery.” Like the FMS 4503, it appears it will be used in conjunction with electrical devices, but it is medical apparatus in itself. Its unusual configuration, materials, and high cost of approximately $50 to the end user identify it as a medical instrument. The serrated inside edge for cutting makes this item akin to a surgical scalpel. You propose classification in HTS 9018.39.00, but while it is a tubular metal piece, its function is more tied to cutting instead of fluid delivery or removal, which is the essential function of catheters and cannulae.

You state that the sample FMS 6724, PLLA Screw, in a sterile bag, is a “Bioresorbable interference screw used in ACL reconstruction to attach the Anterior Cruciate Ligament for the tibia and fibia.” Its unusual shape, the fact that it is bioresorbable and sterile, and its high cost of approximately $49 to the end user identify it as screws and other internal fixation devices as opposed to the plastic screws excluded from Chapter 90 by its Note 1-f.

The applicable subheading for the interface cable, FMS Ref. 4190, will be 8544.51.9000, HTS, which provides for other electric conductors for a voltage exceeding 80 V but not exceeding 1,000 V: Fitted with connectors: Other: Other. The rate of duty will be 2.6 percent ad valorem.

The applicable subheading for the FMS 4503 and 7510 will be 9018.90.8000, Harmonized Tariff Schedule of the United States (HTS), which provides for “other” instruments and appliances used in medical, surgical, dental, or veterinary sciences. The rate of duty will be free.

The applicable subheading for the 4-way Foot Pedal, FMS 4176, will be 8537.10.9070, HTS, which provides for other boards, panels, and other bases for electric control or the distribution of electricity for a voltage not exceeding 1,000 V. The rate of duty will be 2.7 percent ad valorem.

The applicable subheading for the FMS 6724 will be 9021.10.0050, Harmonized Tariff Schedule of the United States (HTS), which provides for Bone plates, screws and nails, and other internal fixation devices or appliances.

The submitted photograph depicts a back brace and a wrist support. The back brace is made of terry cloth fabric bonded to neoprene rubber with two metal stays. The stays do not create sufficient rigidity to immobilize the back. The neoprene rubber forms the outer surface. The brace features an elastic fabric band sewn onto the center. It is held closed with hook and loop fastener.

The applicable subheading for the back brace will be 6307.90.9889, Harmonized Tariff Schedule of the United States (HTS), which provides for other made up articles . . . Other.

The wrist support is constructed of neoprene and lined with terry cloth. It has a shaped metal stay that fits in the lining which is intended to immobilize the wrist to help reduce pain from carpal tunnel syndrome, etc., and promote healing.

The applicable subheading for the wrist support will be 9021.10.0090, HTS, which provides for orthopedic appliances, including crutches, surgical belts and trusses; splints and other fracture appliances.

You state: “The subassembly consists of a 17-4 stainless steel slide, 17-4 stainless steel insert, and a Nickel-Titanium ‘spring’.

As background information: orthodontic brackets are bonded to a patient’s teeth. Archwire is ’threaded’through slots in the brackets. The combination of archwire and brackets moves the teeth in the desired direction.

In Damon 3 brackets, the stainless steel insert is the part of the bracket containing the slot through which the archwire is threaded. The insert also contains the slide and spring. The function of the slide is to keep the archwire in the bracket. The function of the spring is to keep the slide engaged in the closed position. To remove the archwire, the orthodontist depresses the spring and pushes the slide in a downward motion.

Ormco will import Belgian-origin Nickel-Titanium wire in coils through the port of Los Angeles (7505.22.1000). The wire will be cut and formed to exact spring specifications in the United States. (As is apparent in the enclosed drawing and sample, the finished spring does not resemble what one would consider a traditional coiled spring.)

The slides and inserts are made in Japan. Ormco will import them through the port of Los Angeles. Ormco will ship the slides, inserts, and springs to its maquiladora in Mexico for assembly into Damon 3 bracket insert subassemblies.

The Manufacturing Control Instructions the maquiladora will use to create the subassemblies are included for your reference. Per the procedure, the spring will be mounted in a staking fixture, and an arbor press will be used to place it in the insert (see 5.1-Staking insert/spring procedure). The slide will then be attached to the insert with the assistance of an assembly fixture (see 5.2-Slide insertion procedure).

Ormco will then import the bracket insert subassembly into the United States, where it will be placed in a mold. A polycarbonate substance will be injection molded around the insert subassembly to create the bracket.

Ormco will then ship the bracket with the subassembly in place back to Mexico, where the maquiladora will add a ball basing to the back of the bracket to enable it to better adhere to the tooth. The maquiladora will also color code the bracket with ink and package it before returning it to the United States as a finished product.

Ormco respectfully requests a ruling on the classification and country of origin of the Damon 3 orthodontic bracket subassemblies when imported from Mexico (prior to becoming part of the molded bracket in the United States).

Enclosed for your reference please find a bill of material for a complete bracket, along with:

Drawing and sample of spring (part number 097-2088) Drawing and sample of slide (part number 097-2071) Drawing and sample of insert (part number 097-2061) Drawing and sample of insert sub-assembly (part number 097-0102) Drawing and sample of molded bracket (part number 097-2101) Drawing and sample of finished bracket (part number 490-4020)”

We take the sample in the envelope marked Part 097-0102, Insert Sub-Assembly, to be representative of the “Damon 3 orthodontic bracket subassemblies.”

The bracket subassemblies are assembled from parts clearly machined to your specifications, noting the minute and elaborate machine tooling on their surfaces (about .1 inch by .1 inch) so they are parts, not materials.

The applicable subheading for the bracket subassemblies will be 9021.10.0090, Harmonized Tariff Schedule of the United States (HTS), which provides for “other” orthopedic or fracture appliances and parts and accessories thereof. The rate of duty will be free.

The Japanese slide and insert would also be classified in 9021.10.0090, noting Headquarters Ruling Letter 965546 GOB, 8-6-02, so the applicable Nafta origin tariff shift in CR 102.20-q is not met. Note the change to CR 102.20-q regarding HTS 9021.10 made by CBP Decision 03-11, published in the Customs Bulletin of August 6, 2003.

Since the Nafta Preference Overide in CR 102.19 has to be considered, we note that the bracket subassemblies are not entitled to Nafta Preference since those two pieces fail to meet the tariff shift in HTS General Note 12-t-90.47.

Noting CRs 102.11-b-1 and 102.18-b, the country of origin of the bracket subassemblies is Japan.

This letter is in response to correspondence dated September 15, 2003 submitted by former counsel to our office requesting a tariff classification ruling of certain plastic release modules and textile high pull straps under the Harmonized Tariff Schedule of the United States Annotated (HTSUSA) on behalf of the client, Sybron Dental Specialties (dba “SDS Ormco/Sybron Dental Specialties”). Four bags of samples of the merchandise were submitted to this office for our reply.

Further, we considered your supplemental submission dated December 14, 2003 in which you requested reconsideration of the classification of cervical neck pads. We determined that we are unable to rule on cervical neck pads as the original submission did not address them and CBP has issued a prior ruling on them. See Headquarters Ruling Letter (HQ) 965623, dated September 25, 2002. In addition, you indicated in further conversation with a member of my staff that your client would like reconsideration of this previous classification ruling on cervical neck pads which was issued by this office. However, CBP regulations do not provide for reconsideration of a pre-existing ruling in the context of a prospective ruling and you have been advised to submit a separate written reconsideration request for the ruling which addresses the cervical neck pad commodity as provided by 19 C.F.R. §177.12.

FACTS:

You stated in supplemental correspondence received by facsimile on December 15, 2003 that your client, Sybron Dental Specialties (aka “SDS Ormco as indicated on the submitted sample plastic bags) is an affiliate to Ormco Corporation. You stated that your client and Ormco manufacture and import all kinds of dental products for sale to the medical and dental markets. Ormco, on the other hand, only specializes in the manufacture, import and sale of orthodontic appliances and instruments, and endodontic instruments.

You submitted four plastic bags, which contained three high pull straps in colors of fuschia, neon green, and black. The label on the three high pull strap samples state: “Brite-Gear™” with the words “High Pull Straps-Pack of 10”. The other bag contains plastic release modules, identified as “C-Type Release Module—Part No. 715-2021”. The label on the release module samples also states that the release module is “heavy force” and “made in Switzerland”. Each of the four bags contains the same paper insert which lists a break-away release module and high pull strap.

We note that the label also states “Cervical pads-pack of 10.” However, as indicated, cervical pads are not at issue in this ruling.

In the original submission, it is stated that all of the orthodontic appliances are various parts of imported headgear systems used as a part of orthodontic treatment to straighten the patient’s teeth. It is also stated that Ormco imports the two parts of the system, the high pull straps and release modules.

The high pull strap is constructed of 100 percent Nylon, and measures 3/4 inches in width and .7 millimeters in thickness. When in use on a patient, it is indicated that Ormco’s headgear system is constructed of a metal face bow (not subject to the instant ruling), the subject plastic break-way release module (of which there are two types discussed below), and the nylon high pull straps. The release modules are two styles: one square end and a c-type release module, both may be of medium or high force.

ISSUE:

What is the proper classification of the plastic release module and textile high pull strap under the Harmonized Tariff Schedule of the United States Annotated (HTSUSA)?

LAW AND ANALYSIS:

Merchandise is classifiable under the Harmonized Tariff Schedule of the United States Annotated (HTSUSA) in accordance with the General Rules of Interpretation (GRIs). GRI 1 provides that classification shall be determined according to the terms of the headings and any relative Section or Chapter Notes. When goods cannot be classified solely on the basis of GRI 1 and if the headings or notes do not require otherwise, the remaining GRIs 2 through 6 may be applied.

Additionally, the Harmonized Commodity Description and Coding System Explanatory Notes (ENs) are the official interpretation of the Harmonized System at the international level. While neither legally binding nor dispositive, the ENs provide a commentary on the scope of each heading of the HTSUS. See T.D. 89 80, 54 Fed. Reg. 35127, 35128 (August 23, 1989).

The original submission claims that the two items at issue whether imported together or separately, are classifiable in subheading 9021.10.0090, HTSUSA, which provides for parts of orthodontic appliances.

Heading 9021

Note 1(a) to Chapter 90 states, in relevant part:

This chapter does not cover:

(a) Articles of a kind used in machines, appliances or for other technical uses,of textile material (heading 5911).

Chapter 59 is limited to impregnated, coated, covered or laminated textile fabrics, and textile articles of a kind suitable for industrial use. The two styles of the subject release module are made of plastic and the high pull straps are made of nylon material. The term “technical uses” is described in Note 7(b) to Chapter 59 as those “of a kind in papermaking or similar machines (for example, for pulp or asbestos-cement), gaskets, washers, polishing discs and other machinery parts.)” However, in this case, heading 5911 is inapplicable because the subject articles, although used in conjunction with the metal facebow, do not meet the definition of “technical purposes” as provided within Note 7(b), HTSUSA. Neither article is used in conjunction with any machinery process or activity, rather they are used in conjunction with the metal facebow to straighten teeth (which is not involved in machinery process or activity). Thus, Note 1(a) to Chapter 90 does not apply.

Note 1(f) to Chapter 90 states:

This chapter does not cover: Parts of general use, as defined in note 2 to section XV, of base metal (Section XV) or similar goods of plastics (chapter 39).

The term “parts of general use” as defined by Note 2 to Section XV, HTSUSA, refers to:

Articles of heading 7307, 7312, 7315, 7317 or 7318 and similar articles of other base metals;

Springs and leaves for springs, of base metal, other than clock or watch springs (heading 9114); and

(c) Articles of heading 8301, 8302, 8308 or 8310 and frames and mirrors, of base metal, of heading 8306.

In chapters 73 to 76 and 78 to 82 (but not in heading 7315) references to parts of goods do not include references to parts of general use as defined above.

Subject to the preceding paragraph and to note 1 to chapter 83, the articles of chapter 82 or 83 are excluded from chapters 72 to 76 and 78 to 81.

In this instance, the subject plastic release modules and nylon high pull straps are not goods of a kind which are similar to “parts of general use” as outlined in Note 2 above. Neither article possesses a general function, as in the case of a clasp or buckle. Rather both articles possess specialized orthodontic designs that work in conjunction with each other to align the wearer’s teeth. Therefore, we do not find Note 2(f) precludes the two articles at issue from classification in Chapter 90, HTSUSA.

Heading 9021, HTSUSA, provides for, among other things, orthopedic appliances, including crutches, surgical belts and trusses. According to the EN to the heading, an article may be classifiable as an orthopedic appliance within heading 9021 if it either:

Prevents or corrects bodily deformities; or Supports or holds parts of the body following an illness, operation or injury.

Note 7 to EN 90.21 states that orthopedic appliances include “dental appliances for correcting deformities of the teeth (braces, rings, etc.).” The original submission made by former counsel to your client states that the two articles “when assembled togetherhelp straighten the patient’s teeth.” It is also stated that “[o]rthodontic headgear may be used to hold or move teeth or an entire arch [by creating force] that guide the growth of the face and jaws” and “mov[ing] teeth into better positions or to prevent teeth from moving where they are not supposed to [be].” Given these facts, it is our opinion that the subject high pull strap and plastic release modules are parts of appliances of heading 9021, HTSUSA.

Both of the subject articles are imported and sold separately: the release modules are made in Switzerland and the textile high pull straps are made in Mexico, but are used together with the metal face bow. As they are imported separately, they are not a set put up for retail sale nor composite goods of GRI 3. Rather, we find them to be classifiable separately as provided by GRI 1, HTSUSA, as parts of appliances of heading 9021, HTSUSA. We refer to Chapter Note 2(b), Chapter 90, which states, in pertinent part:

Subject to note 1 above, parts and accessories for machines, apparatus, instruments or articles of this chapter are to be classified according to the following rules:

(b) Other parts and accessories, if suitable for use solely or principally with a particular kind of machine, instrument or apparatus, or with a number of machines, instruments or apparatus of the same heading (including a machine, instrument or apparatus of heading 9010, 9013 or 9031) are to be classified with the machines, instruments or apparatus of that kind.

Based on the two articles at issue, in their condition as imported, it is our determination that they are designed to be used solely or principally with the orthopedic headgear system. Thus, they are classifiable pursuant to GRI 1, within subheading 9021.10.0090, HTSUSA, which provides for, among other things, parts of orthopedic appliances

HOLDING:

Pursuant to GRI 1, the square end and c-type release module and the nylon high pull straps are classifiable in subheading 9021.10.0090, HTSUSA, which provides for, among other things, parts of orthopedic appliances. The duty rate is FREE.

This is in response to your memorandum forwarding a request for internal advice initiated by letter dated April 29, 2003, by Serko & Simon LLP on behalf of Neodontics International, Inc., d/b/a G & H Wire Company (“G & H” or “petitioner”) concerning the tariff classification of certain stainless steel wire products used for orthodontic purposes manufactured by A.J. Wilcock Pty Ltd. (“AJW”) under the Harmonized Tariff Schedule of the United States (“HTSUS”).

FACTS:

There are four types of merchandise manufactured by AJW at issue. This merchandise is described by petitioner as: (i) wire in 10-inch straight lengths, (ii) wire coiled on spools, (iii) uprighting springs, and (iv) archwires. Each type of merchandise is made of type 302 stainless steel. The wire products manufactured by AJW are collectively referred to as “AJW wire,” “Australian Wire,” and “Wilcock Wire.”

The wire in 10-inch straight lengths has either a circular or rectangular cross section. The 10-inch straight length wire with a circular cross section is made in sizes measuring between 0.008 of an inch and 0.024 of an inch in diameter. The 10-inch straight length wire with a rectangular cross section is made in sizes measuring between 0.016 of an inch by 0.022 of an inch and 0.0215 of an inch by 0.027 of an inch. In its letter, petitioner describes this wire as follows: “[t]his convenient to use and easy to store wire is used by orthodontists in the dental procedure of teeth straightening. This product is imported in tubes containing either 10 or 30 wires per tube. Braces aided by the wires move teeth to the desired position.”

The wire coiled on spools has a circular cross section and is available in different grades depending on tensile strength and flexibility/resiliency requirements. The wire is made in sizes measuring between 0.008 of an inch and 0.024 of an inch in diameter. There is 25 feet of coiled wire on each spool. In its letter, petitioner describes this wire as follows: “[a]n orthodontist cuts the required amount of this product off the spool for use with braces in the teeth straightening process. This product is not as convenient to use as the straight length wire but it serves the same purpose.”

The uprighting springs are made in shapes specific to the size and location of the tooth that they are designed to be used on and the direction in which they are bent (e.g., lower right clockwise). They are imported in packets of 10 springs. The uprighting springs are made of wire with circular cross section measuring between 0.010 of an inch and 0.014 of an inch. In its letter, petitioner describes the springs as follows: “[t]his product is inserted by orthodontists into the patient’s mouth in order to upright and reposition individual teeth.”

The archwires are wires that have been formed into arches and have either horizontal or vertical circles formed into the arch. They are imported in packets of 10. The archwires are made in wire sizes measuring between 0.016 of an inch by 0.016 of an inch and 0.0215 of an inch by 0.027 of an inch. In its letter, petitioner describes the archwires as follows: “[t]his product is used by orthodontists who prefer a preformed product rather than taking the time to form the wire themselves. The archwires are best described as horseshoe shapes that correspond to the anatomical shape of an orthodontic patient’s jaw line and dental arch.”

Each of the four types of merchandise are intended exclusively for orthodontic use. In its request, petitioner states the following in regard to the AJW wire:

AJW wire has special and unique characteristics that greatly improve and enhance its tensile strength and resiliency to extraordinary levels beyond what would otherwise be typical of a 302 grade stainless steel. With reference to the quality of the wire, we quote from page 1 of the AJW catalog: “For over fifty years, ‘Australian Wire’ has been a household name in orthodontics. The extraordinary properties of these wires are due to the research and fine engineering skills employed in the processing of the wires. Wilcock wires are well known for their resilience and ability to withstand masticatory forces as well as being able to maintain their shape even when auxiliaries and elastics are used. There is no other wire which opens the bite as effectively as Wilcock wire.”

Aside from statements like the one above, petitioner does not provide any specific information on how AJW wire differs from ordinary type 302 steel wire.

ISSUE:

What is the classification of the (i) wire in 10-inch straight lengths, (ii) wire coiled on spools, (iii) uprighting springs, and (iv) archwires under the HTSUSA?

LAW AND ANALYSIS:

Classification under the HTSUSA is made in accordance with the General Rules of Interpretation (GRI). GRI 1 provides, in part, that classification decisions are to be “determined according to the terms of the headings and any relative section or chapter notes.” In the event that goods cannot be classified solely on the basis of GRI 1, and if the headings and legal notes do not otherwise require, the remaining GRI may then be applied, in order. The Harmonized Commodity Description and Coding System Explanatory Notes (EN) constitute the official interpretation of the Harmonized System at the international level (for the 4 digit headings and the 6 digit subheadings) and facilitate classification under the HTSUSA by offering guidance in understanding the scope of the headings and GRI. While neither legally binding nor dispositive of classification issues, the EN provide commentary on the scope of each heading of the HTSUSA and are generally indicative of the proper interpretation of the headings. See T.D. 89-80, 54 Fed. Reg. 35127-28 (Aug. 23, 1989).

In its request for internal advice, petitioner asserts that the four types of merchandise are classifiable under subheading 9021.10.0050, Harmonized Tariff Schedule of the United States Annotated (HTSUSA), which provides for, “[o]rthopedic appliances : [o]rthopedic or fracture appliances , [b]one plates, screws and nails, and other internal fixation devices or appliances.” Therefore, subheading 9021.10.0050, HTSUSA, will be considered for each type of merchandise.

We note that petitioner does not assert that the articles are classifiable as parts or accessories of orthopedic appliances under heading 9021.10.0090, HTSUSA. We will first address the classification of the wire in 10-inch straight lengths and the wire coiled on spools. We will then turn to the classification of the uprighting springs and archwires.

The HTSUS provisions under consideration for the wire in 10-inch straight lengths are:

9021 Orthopedic appliances, including crutches, surgical belts and trusses; splints and other fracture appliances; artificial parts of the body; hearing aids and other appliances which are worn or carried, or implanted in the body, to compensate for a defect or disability; parts and accessories thereof:

9021.10.00 Orthopedic or fracture appliances, and parts and accessories thereof:

9021.10.0050 Bone plates, screws and nails, and other internal fixation devices or appliances

7222 Other bars and rods of stainless steel; angles, shapes and sections of stainless steel:

7222.20.00 Bars and rods, not further worked than cold-formed or cold-finished

The HTSUS provisions under consideration for the wire coiled on spools are subheading 9021.10.0050, HTSUSA, and:

7223.00 Wire of stainless steel

7223.00.10 Round wire

For simplicity, the wire in 10-inch straight lengths and the wire coiled on spools may hereinafter be jointly referred to as the “instant wire” or the “wire at hand.”

In the case at hand, petitioner claims that, at the time of importation, that the instant wire is an unfinished orthopedic appliance, having the essential character of complete or finished goods provided for in heading 9021, HTSUSA. We note that pursuant to Note 6 to Chapter 90, HTSUS, “orthopedic appliances” include “appliances for preventing or correcting bodily deformities, such as orthodontic braces. This claim is based on petitioner’s assertion that the instant wire’s identity is “fixed with certainty” as an orthopedic appliance at the time of its importation. In its letter, petitioner repeatedly states that the instant wire “only requires cutting” for use, that it “does not have to be combined with other materials to produce an article,” and that it is “not commercially capable of any other use.” In support of its claim, petitioner cites several court cases decided under the Tariff Schedules of the United States (TSUS), the HTSUS’ predecessor tariff code. As you know, cases decided under the TSUS are not dispositive in interpreting the HTSUS. However, on a case-by-case basis such decisions may be instructive, particularly where the nomenclature remains unchanged and no dissimilar interpretation is required by the text of the HTSUS. However, the cases that petitioner cites do not deal with compellingly similar merchandise, nor do they contain any discussion of essential character, a concept that did not exist under the TSUS. For these reasons, the cited cases are of little value as precedent under the HTSUS. Petitioner also cites Baxter Healthcare Corporation v. United States, 182 F.3d 1333 (1999), a “parts” vs. “materials” case decided under the HTSUS. Yet, petitioner does not assert that the instant wire is classified as a part of an orthopedic appliance, but an unfinished orthopedic appliance. Furthermore, the Baxter case does not deal with compellingly similar merchandise. For these reasons, the Baxter case is also of little value as precedent. Petitioner also cites several rulings issued by the Bureau of Customs and Border Protection. Because the cited rulings are “parts” vs. “materials” rulings and involve facts and merchandise that are clearly distinguishable from the facts and merchandise in this case, we conclude that these rulings are not precedent here.

While we have undertaken a full and comprehensive review of all the legal arguments that petitioner raised in its letter, noting the principles of Apple Computer Inc. v. United States, 749 F. Supp. 1142 (CIT 1990), we will limit our discussion to the issue on which this case turns. In our opinion, whether the instant wire qualifies as “blanks” under the provisions of GRI 2(a) relating to unfinished articles is the issue on which this case turns.

GRI 2(a) states that “[a]ny reference to an article shall be taken to include a reference to that article incomplete or unfinished, provided that, as entered, the incomplete or unfinished article has the essential character of the complete or finished article.” EN General Note II to Chapter 90, HTSUS, echoes this tenet stating, “[p]rovided that they have the essential character of the complete or finished article, incomplete or unfinished machines, appliances, instruments or apparatus are classified with the corresponding complete or finished articles .”

In regard to incomplete or unfinished articles, the EN to GRI 2(a) states, in relevant part:

(II) The provisions of this Rule also apply to blanks unless these are specified in a particular heading. The term “blank” means an article, not ready for direct use, having the approximate shape or outline of the finished article or part, and which can only be used, other than in exceptional cases, for completion into the finished article or part .

Semi-manufactures not yet having the essential shape of the finished articles (such as is generally the case with bars, discs, tubes, etc.) are not regarded as

The EN establish two criteria for articles which are “blanks” for GRI 2(a) purposes: approximate shape or outline and sole use for completion into the finished article or part. We find that the instant wire fails both parts of the test. As imported, the instant wire is either coiled on spools or in straight lengths. While the wire may be intended solely for orthodontic use, as imported, it does not have the form nor shape, or any visually identifiable characteristic of an orthopedic appliance. Rather, as imported, the instant wire is type 302 stainless steel coiled on spools or in straight lengths and nothing more. Contrary to petitioner’s assertions, the instant wire requires significantly more than cutting to be transformed into an orthopedic appliance. Not only does the wire have to be cut, it also has to be fit to a patient’s mouth, and combined with other components (such as bonding material, brackets, metal bands, elastics, etc.) to form braces. The wire, used by itself, would serve no useful orthopedic purpose. Of equal importance, there is no evidence that the instant wire can only be used for completion into an orthopedic appliance. While petitioner states that it has “established that [the instant] orthodontic wire is not commercially capable of any other use,” we disagree. Though petitioner makes general statements regarding the instant wire’s special and unique characteristics, the record does not establish that wire at hand is incapable of being used in applications as ordinary type 302 stainless steel wire. For these reasons, the instant wire does not qualify as blanks for tariff purposes, and does not have the essential character of an orthopedic appliance of heading 9021, HTSUS.

The wire in 10-inch straight lengths at issue meets the definition of “[o]ther bars and rods” set forth in Note 1(m) to Chapter 72, HTSUS, the chapter covering steel and iron. Under that Note, “other bars and rods” are defined as products which do not conform to the definition of wire, which have a uniform solid cross section along their whole length in the shape of circles rectangles (including squares) or other convex polygons (including ‘flattened circles’ and ‘modified rectangles’ ” Note that the instant wire in 10-inch straight lengths does not meet the definition of “wire” (in Note 1(o) to Chapter 72, HTSUS) because it is not “in coils.” The instant wire in 10-inch straight lengths is specifically described by subheading 7222.20.00, which provides for: “[o]ther bars and rods of stainless steel : [b]ars and rods, not further worked than cold-formed or cold finished.” We, therefore, find that the instant wire in 10-inch straight lengths is classified in subheading 7222.20.00, HTSUS, pursuant to GRI 1.

The wire coiled on spools at issue meets the legal definition of wire set forth in Note 1(o) to Chapter 72, HTSUS. Under that Note, “wire” is defined as “[c]old-formed products in coils, of any uniform solid cross section along their whole length, which do not conform to the definition of flat-rolled products.” The instant wire coiled on spools is described by subheading 7223.00.10, HTSUS, which provides for: “[w]ire of stainless steel: Round wire.” Therefore, pursuant to GRI 1, we find that it is classified in this provision.

We now turn to the classification of the uprighting springs. The HTSUS provisions under consideration are as follows:

9021 Orthopedic appliances, including crutches, surgical belts and trusses; splints and other fracture appliances; artificial parts of the body; hearing aids and other appliances which are worn or carried, or implanted in the body, to compensate for a defect or disability; parts and accessories thereof:

9021.10.00 Orthopedic or fracture appliances, and parts and accessories thereof:

9021.10.0050 Bone plates, screws and nails, and other internal fixation devices or appliances

7320 Springs and leaves for springs, of iron or steel:

7320.90 Other:

7320.90.50 Other:

7320.90.5020 Other

Note 1 to Chapter 90, HTSUS, states in pertinent part:

1. This chapter does not cover:

(f) Parts of general use, as defined in note 2 to section XV, of base metal (section XV) .

“Springs and leaves for springs, of base metal, other than clock or watch springs ” are identified as parts of general use by Section XV, Note 2(b). We note that “base metal” includes steel (see Section XV, Note 3). Therefore, the uprighting springs are precluded from classification in Chapter 90, HTSUS, and cannot be classified under subheading 9021.10.0050 or subheading 9021.10.0090, HTSUSA. We find the uprighting springs are classified under subheading 7320.90.5020, HTSUSA, which provides for: “Springs and leaves for springs, of iron or steel: Other: Other, Other” pursuant to GRI 1.

We now turn to the classification of the archwires. The HTSUS provisions under consideration are as follows:

9021 Orthopedic appliances, including crutches, surgical belts and trusses; splints and other fracture appliances; artificial parts of the body; hearing aids and other appliances which are worn or carried, or implanted in the body, to compensate for a defect or disability; parts and accessories thereof:

9021.10.00 Orthopedic or fracture appliances, and parts and accessories thereof:

9021.10.0050 Bone plates, screws and nails, and other internal fixation devices or appliances

9021.10.0090 Other

EN General Note III to Chapter 90, HTSUS, reiterates Note 2, stating that parts “ identifiable as suitable for use solely or principally with the machines, appliances, instruments, or apparatus of this Chapter are classified with those machines, appliances, etc.”

In contrast to the wire in 10-inch straight lengths and the wire coiled on spools at hand, the archwires have been formed into arches and have either horizontal or vertical circles formed into their arch. As imported, the shape of the archwires corresponds to the anatomical shape of an orthodontic patient’s jaw line and dental arch. The archwires’ shape and presence of the horizontal or vertical circles make them suitable solely for use as a part in braces. As the archwires have the approximate shape or outline of a part of a finished orthopedic appliance and they are suitable solely for use as a part in braces, we find that they qualify as “blanks” under GRI 2(a) and as classified as parts of an orthopedic appliance under heading 9021, HTSUS. We note that because the archwires do not have the approximate shape or outline of a finished orthopedic appliance, and because they must be joined with other components (such as bonding material, brackets, metal bands, or elastics) to form a finished orthopedic appliance (i.e., braces), we find that they do not qualify as “blanks” in regard to an unfinished orthopedic appliance.

Lastly, in its letter petitioner asserts that “[a]n inconsistency created by a 1999 ruling after three rulings were favorable to the classification of orthodontic wire under Chapter 90 necessitated this request for internal advice.” Petitioner refers to NY E85612, dated August 30, 1999 and asserts that the holding of this ruling conflicts with the holdings in NY 805333, dated January 5, 1995, NY 805390, dated January 6, 1995, and NY 808498, dated April 21, 1995. We disagree.

In NY 805333, we classified a stainless steel “orthodontic ligature” consisting of “a 14-inch wire bent in two and the closed end shaped into a geometrical pattern with a small soldered loop” in subheading 9021.19.8500, HTSUSA, the provision in 1995 that provided for “[a]rtificial joints and other orthopedic or fracture appliances; parts and accessories thereof, [o]ther.” Similarly, in NY 805390, we classified “preformed archwires” described as “wire arched to fit the contours of the mouth used in orthodontic work in conjunction with braces” in subheading 9021.19.8500, HTSUSA. In NY 808498, we classified stainless steel “straight archwires” in subheading 9021.19.8500, HTSUSA. As all records relating to NY 808498 were lost as a result of the terrorist incident in New York on September 11, 2001, the only information that we have about the merchandise is the text of NY 808498. However, it is known in the orthodontic industry that “straight archwires” are preformed archwires for use in the “straight method” of straightening teeth. “Straight” does not refer to the archwires being straight and unformed. Thus, we believe that the articles in NY 805333, NY 805390, and NY 808498 were all preformed archwires with approximate outlines of the parts that they were to be used as and were held to be unsuitable for any other commercial use besides being used as parts in orthopedic appliances.

NY E85612 addressed the classification of AJW wire made of type 302 stainless steel in 10-inch and 12-inch straight lengths and AJW wire coiled on spools. The AJW wire in 10-inch straight lengths and coiled on spools are the same as the articles classified in this response. In E856612, we classified the AJW wire in straight lengths in subheading 7222.20.00, HTSUS, the same subheading that we classify the AJW wire in 10-inch straight lengths in this response. We classified the AJW wire coiled on spools in subheading 7223.00.1030, HTSUSA, the same subheading that we classify the AJW wire coiled on spools in this response (with the statistical suffix omitted in this response due to instant wire coiled on spools having a range of diameters).

In regard to the alleged inconsistency, petitioner states: “[t]he 1999 ruling [NY E85612] reflects no knowledge or consideration of the 1995 rulings [NY 805333, NY 805390, and NY 808498] in reaching its contrary conclusion.” We do not find the holding of NY E85612 to be contrary to the holdings of NY 805333, NY 805390, and NY 808498. The merchandise involved in NY E85612 is substantially different from the merchandise in NY 805333, NY 805390, and NY 808498. As mentioned above, in each of these three rulings we found preformed archwires to be classified as parts of an orthopedic appliance. The articles in NY E85612 are not archwires, but stainless steel wire in straight lengths and coiled on spools. Note that the archwires covered by this ruling are classified in subheading 9021.10.0090, HTSUSA, the current provision for parts of orthopedic appliances.

HOLDINGS:

The wire in 10-inch straight lengths is classified in subheading 7222.20.0045, HTSUSA, which provides for “[o]ther bars and rods of stainless steel : [b]ars and rods, not further worked than cold-formed or cold-finished, [o]ther: [w]ith a maximum cross-sectional dimension of less than 18 mm.” The applicable duty rate is 1.1% ad valorem. The wire coiled on spools is classified in subheading 7223.00.10, HTSUS, which provides for “[w]ire of stainless steel: [r]ound wire.” Classification at the 10-digit level will depend on the diameter of the wire. The applicable duty rate is 0.9% ad valorem. The uprighting springs are classified in subheading 7320.90.5020, HTSUSA, which provides for: “[s]prings and leaves for springs, of iron or steel: [o]ther: [o]ther: [o]ther.” The applicable duty rate is 2.9% ad valorem. The archwires are classified in subheading 9021.10.0090, HTSUSA, which provides for, in addition to other merchandise, “[o]rthopedic appliances parts and accessories thereof: [o]rthopedic or fracture appliances, and parts and accessories thereof: [o]ther.” Merchandise classified in subheading 9021.10.0090, HTSUSA, has a duty free rate.

Pursuant to the Section 201 steel safeguard measures implemented by Presidential Proclamation 7529, and terminated by Presidential Proclamation 7741, certain bars and rods of stainless steel classified in subheading 7222.20.00, HTSUS, and entered or withdrawn from warehouse after March 20, 2002, through December 5, 2003, are subject to the additional ad valorem duties specified by subheadings 9903.73.97 through 9903.74.06, HTSUS, depending on the date that they were entered or withdrawn from warehouse. The instant wire in 10-inch straight lengths is subject to such duties. Under the same measures, certain stainless steel wire coiled on spools classified in subheading 7223.00.10, HTSUS, and entered or withdrawn from warehouse after March 20, 2002, through December 5, 2003, are subject to the additional ad valorem duties specified by subheadings 9903.74.18 through 9903.74.24, HTSUS, depending on the date that they were entered or withdrawn from warehouse. The instant wire coiled on spools is subject to such duties.

This is in response to your letter of April 28, 2004, on behalf of your client, Sybron Dental Specialists (Sybron), and its subsidiary Ormco Corporation (Ormco), in which you request reconsideration of Headquarters Ruling Letter (HQ) 965623, issued to your client on September 25, 2002, concerning the classification under the Harmonized Tariff Schedule of the United States (HTSUS) of cervical neck pads. The cervical neck pads were classified in subheading 6307.90.9889, HTSUS, which provides for “Other made up articles, including dress patterns: Other: Other: Other, Other: Other.” You assert that the cervical neck pads are specially dedicated for use as cervical headgear designed to exert the appropriate amount of tension to prevent malocculsion. Since the issuance of that ruling, CBP has reviewed the classification of this item and has determined that the cited ruling is in error.

We note that in HQ 966754, dated December 30, 2003, this office issued your client a ruling classifying certain plastic release modules and textile high pull straps to be used in conjunction with the cervical neck pads in subheading 9021.10.0090, HTSUS, which provides for, among other things, parts of orthopedic appliances.

Pursuant to section 625(c)(1), Tariff Trade Act of 1930 (19 U.S.C. 1625(c)), as amended by section 623 of Title VI (Customs Modernization) of the North American Free Trade Agreement Implementation Act (Pub. L. 103-182, 107 Stat. 2057), notice of the proposed revocation of HQ 965623 was published on August 25, 2004, in Vol. 38, No. 35, of the Customs Bulletin. No comments were received in response to the notice.

FACTS:

Ormco, is a manufacturer of orthodontic and related dental products, including orthodontic headgear systems. When in use on a patient, Ormco’s headgear systems are made up of a metal facebow and a Break-Away Release Module System. Each of the components are imported separately. The facebow’s outer arch hooks into a Break-Away Release Module System, which fastens around the user’s neck. The Break-Away Release Module System consists of a cervical neck pad or a high pull head cap with a spring release module and plastic straps attached at each end by means of a plastic clasp assembly. The plastic straps attached to each end of the facebow are adjustable. Each of the two straps has twelve holes along it. The ends of the facebow are inserted into the appropriate holes to exert the appropriate amount of tension to treat malocclusion. The cervical neck pads and high pull head caps also hold the facebow in place in the patient’s mouth and together with the plastic straps, exert the appropriate amount of tension to treat the patient.

We note that in the prior submission upon which HQ 965623 was based, your client indicated that the cervical neck pad’s primary function was to provide comfort and support to the user’s neck. Your client further stated that while the neck pad does encourage downward jaw growth, it is not the neck pad in particular that accomplishes this. The cervical neck pads measure 7 ½” by 1 ½” and are made from textile and foam padding with a nylon band sewn into one side of the pad.

ISSUE:

Whether the subject cervical neck pads are classifiable as other made up articles under subheading 6307.90.9889, HTSUS, or as parts and accessories of orthopedic appliances under subheading 9021.10.0090, HTSUS.

LAW AND ANALYSIS:

Classification of goods under the HTSUSA is governed by the General Rules of Interpretation (GRI). GRI 1 provides that classification shall be determined according to the terms of the headings of the tariff schedule and any relative section or chapter notes. In the event that the goods cannot be classified solely on the basis of GRI 1, and if the headings and legal notes do not otherwise require, the remaining GRI may then be applied. The Harmonized Commodity Description and Coding System Explanatory Notes (EN), constitute the official interpretation at the international level. While neither legally binding nor dispositive, the EN provide a commentary on the scope of each heading of the HTSUSA and are generally indicative of the proper interpretation of the headings.

Heading 6307, HTSUS, covers other made up articles of textile materials. The EN to heading 6307, HTSUSA, indicate that the heading covers made up articles of any textile material which are not included more specifically in other headings of Section XI or elsewhere in the Nomenclature.

Thus, a determination must be made whether the cervical neck pads are included more specifically in the other headings of Section XI or elsewhere in the Nomenclature before classifying them in heading 6307, HTSUS.

Heading 9021, HTSUS, provides for, “orthopedic appliances, including crutches, surgical belts and trusses; splints and other fracture appliances; artificial parts of the body; hearing aids and other appliances which are worn or carried, or implanted in the body, to compensate for a defect or disability; parts and accessories thereof.” According to the EN to the heading, an article may be classifiable as an orthopedic appliance within heading 9021 if it either:

(a) Prevents or corrects bodily deformities; or

(b) Supports or holds parts of the body following an illness operation or injury.

EN 90.21 states that orthopedic appliances include “[d]ental appliances for correcting deformities of the teeth (braces, rings, etc.).”

Chapter Note 2(b) states, in pertinent part: “Subject to note 1 above, parts

and accessories for machines, apparatus, instruments or articles of this chapter

are to be classified according to the following rules:”

(b) Other parts and accessories, if suitable for use solely or principally with a particular kind of machine, instrument or apparatus, or with a number of machines, instruments or apparatus of the same heading (including a machine, instrument or apparatus of heading 9010, 9013 or 9031) are to be classified with the machines, instruments or apparatus of that kind[.]

A device may be considered a “part” of an article even though the device is not necessary to the operation of the article, provided that once the device is installed the article cannot function properly without it. Clipper Belt Lacer Co., Inc. v. United States, 14 C.I.T. 146, 738 F.Supp. 528 (1990), aff’d 923 F.2d 835 (1991).

The cervical neck pad is a part of the cervical headgear that, as your client States, when combined with the facebow, “provide[s] a vector force either straight backward from the teeth towards the back of the bottom of the head, or upward and backward from the teeth towards the crown of the head” and “without the neck pad/ Breakway Release Module System, the cervical headgear would not effectively correct such malocclusions.” Given these facts, the cervical neck pad is a part of appliances of heading 9021, HTSUSA.

HOLDING:

The cervical neckpad is classified in subheading 9021.10.0090 HTSUS, which provides for “Orthopedic appliances, including crutches, surgical belts and trusses; splints and other fracture appliances; artificial parts of the body; hearing aids and other appliances which are worn or carried, or implanted in the body, to compensate for a defect or disability; parts and accessories thereof: Orthopedic or fracture appliances, and parts and accessories thereof, Other.” The applicable rate of duty is free.

The merchandise under consideration are five neoprene supports. They are constructed of 1/8” neoprene, which is a textile fabric for tariff purposes, composed of a layer of rubber sandwiched between two layers of knit fabric, in this case nylon. You indicate that they are intended to provide support, compression, and warmth while maintaining air flow for increased comfort and wearing tolerance. The five models are designed for use for the knee, thigh, ankle, wrist, and elbow. Although it is not stated or shown, we assume these are either wrapped around the joint or slipped on.

In your letter, you suggest that these neoprene supports are classifiable in subheading 9021.10.0090, Harmonized Tariff Schedule of the United States (HTS), which provides for orthopedic appliances, including crutches, surgical belts and trusses; splints and other fracture appliances. However, your attention is drawn to Note 1(b) of Chapter 90, which maintains:

This chapter does not cover supporting belts or other support articles of textile material, whose intended effect on the organ to be supported or held derives solely from their elasticity (for example, maternity belts, thoracic support bandages, abdominal support bandages, supports for joints or muscles (Section XI) [emphasis added].

The applicable subheading for the neoprene supports will be 6307.90.9889, HTS (which is found in Section XI) which provides for other made up textile articles, other.

You state, “In brief, the product is waterproof protective cover (made of natural rubber) for people who have had a fractured arm or leg and are wearing a plaster cast, or for those people who have had a lower limb amputation and wear an artificial leg (prosthesis). If a person has a prosthetic limb or is wearing a cast for a fractured limb, they cannot get it wet or the water will damage the cast or the prosthesis. This product allows them to shower, bathe or even swim. Most importantly, people with prosthetic limbs have traditionally had to take off their limb and manoeuvre themselves (with some difficulty), into a shower containing a chair for them to sit on in order to shower. By using this product they can leave their prosthetic leg on and simply shower like anyone else. This gives them better mobility and enhances safety in this situation. The leg unit has a rubberised non-slip sole.”

Per the XeroxSox web site the waterproofness is achieved in the following manner: “Pump out the air – Continue to press the bulb until it remains flat and the XeroSox waterproof clothing is completely wrinkled. Remove the pump and push on the safety cap. Observe the XeroSox waterproof cast and bandage cover for a few minutes before going in the water. As long as the XeroxSox wasterproof clothing stays collapsed and wrinkled, the vacuum is intact and the XeroSox bandage protector cannot leak or come off.”

The XeroSox web site describes it as a “Waterproof Cast and Bandage Cover.” However, we accept the implication in your description that covering bandages is a relatively minor use. Bandages on the arms and legs are not usually left on the patient as long as a cast and many are themselves waterproof so the issue of keeping them dry during bathing, etc, is less likely to arise, especially for any one patient.

The web site indicates that you recommend that they be removed after 45 minutes of use, due to the reduction in blood flow resulting from the squeezing inherent in the process, which further distinguishes them from gloves or footwear in the common meaning of those terms even though they also cover the hand or the foot. Also, they are normally worn in bathtubs, etc., where gloves and footwear are virtually never worn, and they would virtually never be worn as a pair.

Since the XeroSox covers and adds the property of temporary waterproofness to casts and/or prosthetics, we consider them to be identifiable as suitable for use as accessories solely or principally with the apparatus of HTS 9021. They are not covered, per se, by any of the headings cited in Note 2-a to HTS Chapter 90.

Within 9021, it is clear that the arm version, in terms of HTS, Additional US Rules of Interpretation 1-a, is of a class or kind principally used in the US with the orthopedic and fracture appliances of HTS 9021.10. However, the leg version may or may not be principally used with the artificial parts of the body of 9021.31-.39.

We agree that the applicable subheading for the arm version will be 9021.10.0090, Harmonized Tariff Schedule of the United States (HTS), which provides for “other” orthopedic or fracture appliances, and parts and accessories thereof.

You state, “I was advised to contact you by Lisa Struneski, Senior Commercial Specialist, FCS New Zealand. I would appreciate your help in knowing what you would regard as an appropriate Harmonisation Tariff Code for a product.”. Note that only the classification rulings issued by the Harmonized System Committee of the World Trade Organization, of which both the US and New Zealand are members, are binding on other countries, not the rulings of any one of the members, including the US.

Regarding the leg version, we are returning your request for a classification ruling, and any related samples, exhibits, etc., because we need additional information in order to issue a ruling. Please submit the additional information indicated below:

Any information that would indicate separately what percent were sold for use with casts and with prosthetic devices.

Also include a statement as to whether classification advice has been sought from a US Customs officer; and if so, from whom, and what advice was rendered, if any.

RE: The tariff classification of wrist brace/splints from China

You state: “Product number 483020 is an adjustable left wrist brace in size large/extra large. The same brace is available for the right wrist (483022) in size large/extra large and for the left wrist (483019) and the right wrist (483021) in size small/medium. The brace is composed of Coolmax® and nylon. It has an opening for the thumb, two metal splints, and is closed by means of three straps fastened by Velcro.

“The design of both wrist braces provide protection and ‘stability for acute or chronic wrist sprains.’ The splints of the wrist braces fit into the lining and are ‘intended to immobilize the wrist to help reduce pain’ and swelling to an injured area.”

We note that unlike most of the other joints, it is possible to immobilize the wrist from its normal bending yet still readily participate in everyday life and even certain sports.

We agree that the applicable subheading for both items will be 9021.10.0090, Harmonized Tariff Schedule of the United States (HTS), which provides for “other” orthopedic or fracture appliances, and parts and accessories thereof. The rate of duty will be free.

The submitted sample is identified as a Taketora Wedge Strapped Insole for Knee OA. The strap is constructed of 50 percent polyester, 30 percent nylon, and 20 percent polyurethane and is secured around the ankle by a hook-and-loop fastener. The wrap is micro-cellular sponge rubber. It measures approximately 21” x 3”. It apparently stabilizes the knee by supporting the ankle.

In your letter, you suggest that these ankle wraps are classifiable in subheading 9021.10.0090, Harmonized Tariff Schedule of the United States (HTS), which provides for orthopedic appliances, including crutches, surgical belts and trusses; splints and other fracture appliances. However, your attention is drawn to Note 1(b) of Chapter 90, which maintains:

This chapter does not cover supporting belts or other support articles of textile material, whose intended effect on the organ to be supported or held derives solely from their elasticity (for example, maternity belts, thoracic support bandages, abdominal support bandages, supports for joints or muscles (Section XI) [emphasis added].

The applicable subheading for the ankle wrap will be 6307.90.9889, HTS, (which is found in Section XI) which provides for other made up textile articles, other.

You have not presented any samples now, but the “two samples” we referred to in NYRL K89533, mailed to you on October 7, 2004, were in fact the Product Numbers 483759 and 483020, as you stated in your September 13, 2004 letter to us.

We then believed and continue to believe that, in your statement, which we quoted in our 10/7/04 letter, concerning “both wrist braces,” you were referring both to the 483759 and 483020. In particular, from the examination of the two samples then, we agree that both of those wrist braces are “intended to immobilize the wrist to help reduce pain.”

To further clarify our position, we will explicitly state that wrist braces for the right hand are classified in the same HTS as those which are identical other than being the “mirror image” for the other hand. In your statement, after a description of the 483759 in your 9/13/04 letter, “The exact same item for the right wrist is product number 483760,” we understand “exact same” to be a mirror image.

Per your request, we now state explicitly that the applicable subheading for the 483759 and 483760 will be 9021.10.0090, Harmonized Tariff Schedule of the United States (HTS), which provides for “other” orthopedic or fracture appliance, and parts and accessories thereof.

The submitted sample is identified as a Taketora Wrist Support, a wrist band that can be tightened with hook-and-loop fasteners. It measures approximately 8” x 3” and is constructed of 30 percent nylon, 50 percent polyester, and 20 percent polyurethane.

In your letter, you suggest that this wrist support is classifiable in subheading 9021.10.0090, Harmonized Tariff Schedule of the United States (HTS), which provides for orthopedic appliances, including crutches, surgical belts and trusses; splints and other fracture appliances. However, your attention is drawn to Note 1(b) of Chapter 90, which maintains:

This chapter does not cover supporting belts or other support articles of textile material, whose intended effect on the organ to be supported or held derives solely from their elasticity (for example, maternity belts, thoracic support bandages, abdominal support bandages, supports for joints or muscles (Section XI) [emphasis added].

The applicable subheading for the wrist support will be 6307.90.9889, HTS (which is found in Section XI), which provides for other made up textile articles, other.

RE: The tariff classification of a Neck Support ZRO from Japan

Per the packaging for the sample, in large letters, “ NECK SUPPORT ZRO – SOFT TO THE TOUCH BRACE for CERVICAL SUPPORT”.

It also states:

“ Superior fitting provided by the partitioned design helps to reduce causes of cervical kinetic pressure and helps maintain cervical resting position. You can achieve optimal reduction of cervical pressure as the brace can be used either for ‘retroflexion’ or ‘anteflexion’ by simply switching a combination of parts. Since it is made of urethane, it is light weight and allows accurate cervical immobilization.”

Depending on whether the two pieces have been attached together in the retroflexion or anteflexion position, it is almost impossible to angle the head back or forward.

The applicable subheading for the sample will be 9021.10.0000, Harmonized Tariff Schedule of the United States (HTS), which provides for “other” Orthopedic or fracture appliances, and parts and accessories thereof.

RE: The tariff classification of Coronary Stents

You state:

“We are importing and exporting a Medical/Surgical Appliance, by description a Coronary Stent, which is used in Coronary Angioplasty Surgical Procedures. The Stent is delivered to the coronary lesion (blockage) by means of a Coronary Dilatation Balloon Catheter. Once the Stent is in place within the lesion, the Balloon Catheter is inflated which expands to the Stent and releases it from the Balloon Catheter and permanently affixes/implants the Stent within the coronary artery to prevent the artery from re-closing after the Balloon Catheter is removed from the body.

In describing this device to the U.S. Census Commodities Analysis Division, we were led through the Schedule B until we arrived at Schedule B number 9018.39.0030, with the reasoning being that this is a Medical/Surgical Appliance, and since the Stent is delivered to the coronary lesion by means of being attached to a coronary catheter, this would likely be the correct commodity classification number.

I am asking for an written ruling on this classification number, because we have also told that this Stent would fall under Schedule B Section 9021.10.0050 because a Stent is a fixed implantable device. My contention is that Section 9021 covers Orthopedic Appliances and not Coronary Surgical Appliances, and therefore the correct classification is the 9018.xx.xxxx number.”

We understand your item, a Coronary Stent, to be just the precisely cut tubing, presumably made of a metal that is biologically inert, that will be expanded within the blood vessel to serve indefinitely as a support or scaffolding for it and that it does not include the apparatus necessary to get it into place and to expand it.

While we agree that your items are not Orthopedic Appliances, HTS 9021, per the statutory language of the heading, includes, inter alia, Artificial Parts of the Body. Many artificial parts of the body are clearly not orthopedic appliances, e.g., artificial eyes and the tubes of synthetic fiber for replacing blood vessels, both cited in the Harmonized System Explanatory Note III to 90.21.

You propose classification in HTS 9018. However, none of the hundreds of examples in the ENs to 9018 is designed to be left in the body of the patient indefinitely, as is your item.

Although your item is implanted in the body, it is not considered an appliance for the purposes of 9021.90. See HRL 966874 AM, dated May 17, 2004, published in the Customs Bulletin of June 9, 2004.

The applicable subheading for the Coronary Stent will be 9021.39.0000, Harmonized Tariff Schedule of the United States (HTS), which provides for “other” artificial parts of the body and parts and accessories thereof.

You state: “All of our custom molded, made to measure ankle braces originate from a cast taken by a medical professional of an individual’s foot and lower leg. The casts provided by the medical practitioner are referred to as negative casts”

“The negative cast and corresponding order form (prescription) is sent to our facility in Buffalo, New York. We will then fill that negative cast with plaster”

“The positive cast is then digitally scanned and sent to a computer program. At this point, the scanned image is manipulated by a computer operator, so that a properly fitting, therapeutically correct ankle brace can be made which will meet the three dimensions of the foot and leg. This final image is then sent via Internet e-mail to American Ortho-Tech, located in Chennai, India. American Ortho-Tech’s CNC milling machine will then mill a physical plastic replica of the leg and foot. The ankle brace is then made around this physical plastic form.

The brace itself will be made of polypropylene and covered in leather” “The ankle brace will have either a lace or hook and loop closure, or a combination of both types of closures.”

The sample is very rigid and could only be worn by someone, who, in the case of the specific sample, had a severe deformation of the foot towards the midline of the body. We assume that only those with this or another severe musculoskeletal condition would purchase and wear a similar, made to measure item.

It meets the definition of Orthopedic Appliances in Note 6 to Chapter 90.

The applicable subheading for the Ankle Brace will be 9021.10.0090, Harmonized Tariff Schedule of the United States (HTSUS), which provides for “other” Orthopedic or fracture appliances, and parts and accessories thereof.

The submitted sample is identified as a Taketora CM Support. It is a wrist support that measures approximately 11½” x 3¼”. It is constructed of 30 percent nylon, 50 percent polyester, and 20 percent polyurethane. It wraps around the wrist and thumb and is secured by a hook-and-loop fastener.

In your letter, you suggest that the wrist support is classifiable in subheading 9021.10.0090, Harmonized Tariff Schedule of the United States (HTS), which provides for orthopedic appliances, including crutches, surgical belts and trusses; splints and other fracture appliances. However, your attention is drawn to Note 1(b) of Chapter 90, which maintains:

This chapter does not cover supporting belts or other support articles of textile material, whose intended effect on the organ to be supported or held derives solely from their elasticity (for example, maternity belts, thoracic support bandages, abdominal support bandages, supports for joints or muscles (Section XI) [emphasis added].

The applicable subheading for the wrist support will be 6307.90.9889, HTS, (which is found in Section XI) which provides for other made up textile articles, other.

RE: The tariff classification of canes and crutches from China and Taiwan

The items in question include various walking canes made of wood or metal, including a folding cane and a quad cane, so-called because it has four legs for greater stability.

The applicable subheading for the canes will be 6602.00.0000, Harmonized Tariff Schedule of the United States (HTSUS), which provides for walking-sticks, seat-sticks, whips, riding-crops, and the like..

You also seek the classification of a Push-button Aluminum Crutch and Wooden Crutches. These are distinguished from walking-sticks, even if specially made for disabled persons, per Harmonized System Explanatory Note I to its 90.21.

The applicable subheading for the crutches will be 9021.10.0090, HTSUS, which provides for, inter alia, “other” Orthopedic Appliances, including crutches, surgical belts and trusses.

You request duty free treatment for these articles under subheading 9817.00.92, which was inserted into the tariff to implement the Nairobi Protocol. The Nairobi Protocol to the Agreement on the Importation of Educational, Scientific, and Cultural Materials Act of 1982 established the duty-free treatment for certain articles for the handicapped. Presidential Proclamation 5978 and Section 1121 of the Omnibus Trade and Competitiveness Act of 1988 provided for the implementation of the Nairobi Protocol into subheadings 9817.00.92, 9817.00.94 and 9817.00.96 of the Harmonized Tariff Schedule of the United States (HTSUS).

We take it that the “1.0 mm Sternal Cable, 750 mm long, sterile (includes crimping ferrule and parallel end)” is typical of your “orthopedic cables.” It is clear that its only use is to hold the patient’s bones together after surgery.

The plate bending instruments are “designed to bend 2.4 mm Microvascular, Universal Fracture, Locking Reconstruction and THORP Plates in three dimensions” via its elaborate system of locking rotation heads. The tensioners are designed to “tension, crimp and cut” the orthopedic cables during the surgery. Both instruments are designed to be sterilized prior to use.

Per the general Harmonized System Explanatory Note to HS 9018, it includes “tools” which are clearly identifiable as being for medical or surgical use.

We agree that the applicable subheading for the orthopedic cable will be 9021.10.0050, Harmonized Tariff Schedule of the United States (HTSUS), which provides for Bone plates, screws and nails, and other internal fixation devices or appliances. The rate of duty will be free.

The applicable subheading for the plate bending instruments and the tensioners will be 9018.90.8000, Harmonized Tariff Schedule of the United States (HTSUS), which provides for “other” instruments and appliances used in medical, surgical or veterinary sciences and parts and accessories thereof.

You state, “the external midface distractor is an osteogenesis device that attaches to the cranium and midface and is used to correct severe deficiencies and deformities by gradually lengthening the midface.”

You also state, “each component of the external distractor system is of high precision design, is made with surgical grade materials and is designed to withstand the rigors of steam sterilization. The entire system is moved into and used exclusively in the sterile field of the operating room environment.”

You indicate the parts for which you are requesting classification are ”external hardware (headframe, clamps, rods) screws (used in the external application) implantable hardware (pins, plates and roads) screws (to attach the internal parts to bone).”

Some of the elements will be inside the body, but most of them are outside, during the extended period the distractor will stay in place, pulling the patient’s midface out by the desired amount. None are intended to remain permanently.

We understand your information to indicate that each of the parts in question will be made to specifications developed for this device and that you could provide copies of those specifications if requested.

Separately imported parts, if identifiable as parts of this kind of device (see General Harmonized System Explanatory Note III to Chapter 90) or of this particular item (see Headquarters Ruling Letter 965546, 8-2-02), are classified in its heading if not excluded from HTS Chapter 90 by its Note 2-a or 1 or by HTS Add. US Rule of Interpretation 1-c (see HRL 965968, 12-16-02.)

Harmonized System Explanatory Note II to 9021 indicates that certain items that might be considered to be excluded from 9021 by its Note 1-f as Parts of General Use remain in that heading.

These do not appear excluded from HTS Chapter 90 by its Note 2-a or 1 or by HTS Add. US Rule of Interp. 1-c.

We agree that the applicable subheading for the items in question will be 9021.10.0090, Harmonized Tariff Schedule of the United States (HTSUS), which provides for “other” Orthopedic or fracture appliances, and parts and accessories thereof. The rate of duty will be free.

As we understand your request, the items for which you are requesting classification are:

“The ‘AR Spacer’ is made from a biocompatible radiolucent polymer (polyetheretherketone – PEEK)

The ‘Syncage’, ‘Synex’ and ‘Synmesh’ spacers are made from a biocompatible titanium alloy (Ti-6A1-7Nb). These spacers are hollow, to be filled with allograft (or other bone matter) in the surgical application. Each spacer has related pieces (end caps, rings) that fit securely and complete and ‘filled’ spacer.

We also have several lines (donor bone):

The ‘FRA Spacer’ is constructed of femoral ring allograft, the ‘ACTF and PLIF Spacers’, of cortical allograft, and the ‘CCS Spacer’ of cancellous bone (allograft). They are stocked and shipped as freeze dried.”

“the parts for the titanium alloy spacer (rings and endpieces).”

“the plates, rods and screws used for normal internal fixation (*), subsequent to (and NOT dependent upon) the placement of the spacer.”

You state, ”As you will note, by attached reference materials, each type of spacer is described and marketed as a vertebral body replacement device intended for use in the spine. The spacers are designed to provide spinal column support even in the absence of fusion for a prolonged period.” We do see in the product information that the AR and Synex spacers are referred to as “vertebral body replacement parts”.

Regarding the separately imported parts (rings and endpieces) of the titanium alloy spacers, they are clearly made specifically for the vertebral spacers. They do not appear to be excluded from HTSUS Chapter 90 by its Note 2-a or 1 or by HTSUS Add. US Rule of Interp. 1-c.

Regarding the spacers constructed of donor bone, they are analogous to the items in Harmonized System Explanatory Note D-3 to 3001.

Regarding the “plates, rods, and screws,” it is not clear from the product information which items, if any, would be used subsequent to the placement of the spacer. The items that might fit the general description appear to be used ordinarily independent of the use of a spacer. We do not see anything that is indicated as being designed to attach or secure the spacers. You cite ruling “NY 83364,” which we take to be E83356, 7-8-99, but that concerned items for fractures, for which spacers would not ordinarily be used.

Assuming your question is actually whether we consider the reasoning in Harmonized System Explanatory Note III to 9021 regarding the screws used in the “treatment of fractures” to also apply to the special screws used in, e.g., the USS (Universal Spine System) “Variable Axis Screw Assembly” designed as one of the “Solutions for degenerative lumbar instabilities,” we do also consider them to be classified in 9021 since that is an Orthopedic purpose. We would do likewise for the Buttress Locking Plate, “For anterior buttressing of bone graft following single level discectomies in the lumbosacral spine,” the only item we see called a “Plate” in the product information.

We agree that the applicable subheading for the AR, Syncage, Synex, and Synmesh spacers and the rings and endpieces will be 9021.39.0000, Harmonized Tariff Schedule of the United States (HTSUS), which provides for “Other” artificial parts of the body and parts and accessories thereof.

The applicable subheading for the FRA, ACF, PLIF, and CCS spacers will be 3001.90.0000, Harmonized Tariff Schedule of the United States (HTSUS), which provides for, inter alia, other human or animal substances prepared for therapeutic or prophylactic uses, not elsewhere specified or included..

We agree that the applicable subheading for Variable Axis Screw Assembly and the Buttress Locking Plate will be 9021.10.0050, Harmonized Tariff Schedule of the United States (HTSUS), which provides for Orthopedic and fracture appliances, which are Bone plates, screws and nails, and other internal fixation devices or appliances.

This is in response to your undated letter, received by the National Commodity Specialist Division of U.S. Customs and Border Protection (“CBP”) on October 18, 2006, in which you requested a binding ruling on behalf of Synthes (USA). At issue is the proper tariff classification of, and country of origin marking requirements for, medical grade screw blanks and finished screws under the Harmonized Tariff Schedule of the United States (“HTSUS”). Your request included information provided by you in a previous ruling request submitted on August 10, 2006, which was returned to you with a request for additional information. Your letter, with samples appended, was forwarded to this office for a response.

FACTS:

Synthes (USA) is a skeletal fixation company that designs, manufactures and distributes implants and instruments for all aspects of internal and external fixation. At issue are screw blanks made of 316L grade stainless steel that are produced by Synthes in the United States from U.S. sourced material. According to research done on the Internet, grade 316 stainless steel is vacuum melted to achieve the extremely high levels of purity and cleanliness required for surgical implants. Designed for use in corrosive environments, this grade of stainless steel has been used in applications ranging from chemical/industrial to medical devices. See www.americantube.com, “Alloy Selections”, and www.alloywire.com, “Products”.

During manufacturing operations in the United States the machine that makes the blanks is set to size and head specifications of the finished screws. Blanks are cut hundreds at a time. However, no threading, de-burring, polishing or finishing operations are performed in this country. The blanks are kept in inventory in lots of 100s or 1000s until finished screws are needed. The numbering logic for the blanks in inventory and in transit consists of the finished part number followed by “.999”.

When finished screws are needed, the blanks are exported to Switzerland for finishing operations involving several pieces of equipment which clean the blanks, cut the threads and finish the heads. Once an individual screw is complete it is polished, cleaned and packaged, one screw per bag. The screws are not sterilized. When the lot is approved by quality inspection the finished items are returned to the United States. At the time of importation into this country the screws are considered finished goods and are lot number and U.S. Food and Drug Administration (“FDA”) controlled until final sale.

The samples provided are of the 4.5 mm cortex

The outer layer of a solid organ or part of the body, for example, the outer covering of the kidney or brain (cerebral cortex). Encarta Dictionary online. screw (product no. 214.014) and its blank (product no. 214.014.999), and the 4.0 mm cancellous Used to describe bone that has a mesh of hollows on the inside, as opposed to being compact or dense. Id. bone screw (product no. 206.010) and its blank (product no. 206.010.999). According to the information provided, the blanks cannot be processed to create anything other than the finished screw with defined thread and dimensions.

ISSUE:

What is the correct classification of the U.S. manufactured screw blanks?

What is the country of origin of the finished screws?

LAW AND ANALYSIS:

Classification of Screw Blanks

Classification under the HTSUS is made in accordance with the General Rules of Interpretation (GRIs). GRI 1 provides that the classification of goods shall be determined according to the terms of the headings of the tariff schedule and any relative section or chapter notes. In the event that the goods cannot be classified solely on the basis of GRI 1, and if the headings and legal notes do not otherwise require, the remaining GRIs 2 through 6 may then be applied in order.

The HTSUS provisions under consideration are as follows:

7318 Screws, bolts, nuts, coach screws, screw hooks, rivets, cotters, cotter pins, washers (including spring washers) and similar articles, of iron or steel: Threaded articles:

7318.15 Other screws and bolts, whether or not with their nuts or washers: Other:

7318.15.60 Having shanks or threads with a diameter of less than 6mm ..

9021 Orthopedic appliances, including crutches, surgical belts and trusses; ; hearing aids and other appliances which are worn or carried, or implanted in the body, to compensate for a defect or disability; parts and accessories thereof: 9021.10.00 Orthopedic and fracture appliances, and parts and accessories thereof .. 9021.10.0050 Bone plates, screws and nails, and other internal fixation devices or appliances ..

Note 1(h) to Section XV excludes instruments and apparatus of Section XVIII from Section XV. Chapter 73 is in Section XV and Chapter 90 is in Section XVIII of the tariff. Consequently, if the blanks are provided for in Chapter 90 then they are not classifiable in chapter 73.

Note 1(f) to Chapter 90 excludes parts of general use, as defined in note 2 to Section XV, of base metal (section XV) from Chapter 90. Note 2 to Section XV defines “parts of general use” as, among other things, “articles of heading 7318 and similar articles of other base metals.”

Note 2 to Chapter 90 provides, in relevant part:

Subject to note 1 above, parts and accessories for machines, apparatus, instruments or articles of this chapter are to be classified according to the following rules:

(b) Other parts and accessories, if suitable for use solely or principally with a particular kind of machine, instrument or apparatus are to be classified with the machines, instruments or apparatus of that kind[.]

As an initial matter, we address the treatment of “blanks” by the HTSUS. GRI 2(a) provides, in relevant part:

Any reference in a heading to an article shall be taken to include a reference to that article incomplete or unfinished, provided that, as entered, the incomplete or unfinished article has the essential character of the complete or finished article.

The Harmonized Commodity Description and Coding System Explanatory Notes (ENs) constitute the official interpretation of the HTSUS. While not legally binding nor dispositive, the ENs provide a commentary on the scope of each heading of the HTSUS and are generally indicative of the proper interpretation of these headings. See T.D. 89-80. The ENs to GRI 2(a) provide, in pertinent part:

(II) The provisions of this Rule also apply to blanks unless these are specified in a particular heading. The term “blank” means an article, not ready for direct use, having the approximate shape or outline of the finished article or part, and which can only be used, other than in exceptional cases, for completion into the finished article or part (e.g., bottle preforms of plastics being intermediate products having tubular shape, with one closed end and one open end threaded to secure a screw type closure, the portion below the threaded end being intended to be expanded to a desired size and shape).

Semi‑manufactures not yet having the essential shape of the finished articles (such as is generally the case with bars, discs, tubes, etc.) are not regarded as “blanks”.

The screw blanks, although “not ready for direct use, hav[e] the approximate shape or outline of the finished article or part, and . . . can only be used, other than in exceptional cases, for completion into the finished article or part.” Applying the provisions of GRI 2(a) to the articles at issue, we find that the screw blanks that are exported from the United States must be treated as finished screws for classification purposes.

You claim that the screws are classified under heading 9021, HTSUS, as parts of orthopedic appliances, by application of Note 2(b) to Chapter 90. However, Note 2 is subject to the provisions of Note 1 to Chapter 90. In particular, note 1(f) excludes parts of general use, such as articles of heading 7318 (screws, among other things) from being classified in Chapter 90.

CBP has previously considered the nature of screws classifiable in heading 9021, HTSUS. See New York Ruling Letter (“NY”) I82642 (June 20, 2002), regarding sterile, bioresorbable interference screws used in anterior cruciate ligament (“ACL”) reconstruction. See also NY R03768, dated May 10, 2006, in which classification of titanium screws in heading 9021, HTSUS, turned on whether the screws were identifiable as parts of external midface distractors. In this instance, the screws at issue are not identifiable as parts of orthopedic appliances. We note that screws of the same dimension and constituent material as the screws at issue are considered to be medical devices by the FDA. However, CBP need not consider other agency’s regulations in defining tariff terms. Sabritas S.A. de C.V. v. United States, 998 F. Supp. 1123 (CIT 1998). We note further that the screws at issue are made of a grade of stainless steel (316 L) that is suitable for medical use but also that 316L stainless steel is also used in chemical and industrial applications. Further, we have found no information which indicates that these screws are suitable for use only with orthopedic appliances. Given these circumstances, we find that the screws at issue are parts of general use and do not rise to the level of parts suitable for use solely or principally with orthopedic appliances of heading 9021, HTSUS. Consequently, we find that they are excluded from classification in Chapter 90 by application of Note 1(f) and are classified in heading 7318, HTSUS.

Country of Origin

Section 304 of the Tariff Act of 1930, as amended (19 U.S.C. §1304), provides that, unless excepted, every article of foreign origin (or its container) imported into the United States shall be marked in a conspicuous place as legibly, indelibly and permanently as the nature of the article (or its container) will permit, in such a manner as to indicate to the ultimate purchaser in the United States the English name of the country of origin of the article. Congressional intent in enacting 19 U.S.C. §1304 was “that the ultimate purchaser should be able to know by an inspection of the marking on the imported goods the country of which the goods is the product. The evident purpose is to mark the goods so that at the time of purchase the ultimate purchaser may, by knowing where the goods were produced, be able to buy or refuse to buy them, if such marking should influence his will.” United States v. Friedlaender & Co., 27 CCPA 297, 302, C.A.D. 104 (1940). Part 134, U.S. Customs and Border Protection Regulations (19 C.F.R. §134) implements the country of origin marking requirements and exceptions of 19 U.S.C. §1304.

Section 134.1(b), CBP Regulations (19 C.F.R. § 134.1(b)), defines “country of origin” as “the country of manufacture, production, or growth of any article of foreign origin entering the United States. Further work or material added to an article in another country must effect a substantial transformation in order to render such other country the ‘country of origin’ within the meaning of [the marking laws and regulations].” For country of origin marking purposes, a substantial transformation of an article occurs when it is used in manufacture, which results in an article having a name, character, or use differing from that of the article before the processing. However, if the manufacturing or combining process is merely a minor one that leaves the identity of the article intact, a substantial transformation has not occurred. Uniroyal, Inc. v. United States, 3 CIT 220, 542 F. Supp. 1026, 1029 (1982), aff’d, 702 F.2d 1022 (Fed. Cir. 1983).

Under Section 134.32(m), CBP Regulations (19 C.F.R. § 134.32(m)), products of the United States that are exported and returned are excepted from the country of origin marking requirements of 19 U.S.C. § 1304.

In National Hand Tool Corp. v. United States, (“National Hand Tool Corp.”) 16 CIT 308 (1992), aff’d, 989 F. 2d 1201 (Fed. Cir. 1993), the court considered the nature of “substantial transformation”. At issue were sockets and flex handles which were either cold formed or hot forged into their final shape prior to importation from Taiwan, speeder handles which were reshaped by a power press after importation, and the grip of flex handles which were knurled in the U.S. The imported articles were then heat treated which strengthened the surface of the steel, and cleaned by sandblasting, tumbling, and/or chemical vibration before being electroplated. In certain instances, various components were assembled together which the court stated required some skill and dexterity. The court determined that the imported articles were not substantially transformed and that they remained products of Taiwan. In making its determination, the court focused on the fact that the components had been cold‑formed or hot‑forged “into their final shape before importation,” and that “the form of the components remained the same” after the assembly and heat‑treatment processes performed in the U.S. Although the court stated that a predetermined use would not necessarily preclude a finding of a substantial transformation, it noted that such determination must be based on the totality of the evidence. The court then concluded that no substantial change in name, character or use occurred as a result of the processing performed in the U.S. See also Superior Wire v. United States, 867 F.2d 1409 (Fed. Cir. 1989), regarding the origin of wire rod made into wire. CBP has recently discussed the applicability of these and similar court decisions to stainless steel drill bits and other various articles exported from the U.S. for finishing purposes. See Headquarters Ruling Letter (“HQ”) W968396, dated December 21, 2006.

In view of the decision of the Court of International Trade in the National Hand Tool case and its affirmation by the Federal Circuit, we conclude that the processing operations that will be done in Switzerland are finishing operations that will not change the basic nature of the articles at issue. Significantly, the screw blanks shipped to Switzerland are clearly dedicated for use to make the finished screws and cannot be used for any other purpose. Like the hand tool components in National Hand Tool and the stainless steel drill bits in HQ W968386, we find that the screw blanks do not undergo substantial transformation in character or use when they are processed into the finished screws in Switzerland. Rather, the screw blanks and the finished screws represent “different stages of the same product.” In other words, the screw blanks have the very essence of the finished screws and the processing that will be performed in Switzerland does not change the shape, character or predetermined use of the screw blanks.

Based on the information and samples submitted, and in accordance with the above analysis, we find that the screw blanks are not substantially transformed by the processing done in Switzerland; therefore, the country of origin of the finished screws is the United States. In accordance with 19 C.F.R. §134.32(m), the screws are not required to be marked to indicate their country of origin.

HOLDING:

By application of GRI 2(a) and Legal Note 1(f) to Chapter 90, we find that the screw blanks are classified under heading 7318, HTSUS, specifically under subheading 7318.15.60, which provides for, inter alia: “Screws, bolts, nuts, coach screws, screw hooks, rivets, cotters, cotter pins, washers (including spring washers) and similar articles, of iron or steel: Threaded articles: Other screws and bolts, whether or not with their nuts and washers: Other: Having shank or threads with a diameter of less than 6 mm.” For export purposes, the screw blanks are also classifiable under Schedule B number 7318.15.9000.

Regarding the LSP Trauma Air Pants, you state: “The first item is called an LSP Trauma Air Pant which is being imported by MC Industries for sale to their customer Allied Healthcare Products. The LSP Trauma Air Pants are made of 420 Denier Nylon fabric and is designed to promote emergency care for the victim experiencing hypovolemic shock”

You also state: “The LSP Trauma Air Pants are imported without the pump, hoses and gauges shown on the picture. These items are inserted by Allied Healthcare Products after importation.”

The pants are imported with the airtight bladders which, when inflated appropriately, will support/compress/immobilize parts of the body of the patient/trauma victim, typically in an emergency. From the information you supplied, “They provide complete counter-pressure around the legs and abdomen, combining safety and comfort for the patient.” We note that, e.g., the Life Medical Supplier web site categorizes the smaller (pediatric) version of the LSP Trauma Air Pants under its Pediatric Immobilization section, on the same page as Traction Splints, etc.

Note 6 to HTSUS Chapter 90 indicates that the orthopedic appliances of HTSUS 9021 includes appliances for supporting or holding parts of the body following an illness, operation or injury.

You indicate that you believe that HTSUS 9018 applies, apparently on the basis that the item “is considered a medical device by the FDA.” However, the Food and Drug Administration, in the interest of public safety, regulates many items which are clearly not classifiable in HTSUS 9018, e. g., artificial parts of the body of HTSUS 9021.

The applicable subheading for the LSP Trauma Air Pants will be 9021.10.0090, Harmonized Tariff Schedule of the United States (HTSUS), which provides for “other” Orthopedic or fracture appliances, and parts and accessories thereof.

RE: The tariff classification of a Wrist Brace from Taiwan or China

You state, “Physicians often recommend the use of a rigid wrist brace during management of Carpel Tunnel Syndrome and other painful wrist conditions. This product uses adjustable Palmar and dorsal stabilizers for optimal wrist position support, critical for CTS treatment.”

The sample, about 8 inches long, has an elastic insert and an elastic/Velcro-like band, but these appear to be primarily for ease in getting it on. When the two Velcro-like, non-elastic bands at the two ends are tightened, the full length, somewhat flattened S shaped, 1.2 inch wide, quite rigid, metal insert effectively prevents the wearer from bending his wrist.

The applicable subheading for your sample will be 9021.10.0090, Harmonized Tariff Schedule of the United States (HTSUS), which provides for “other” Orthopedic or fracture appliances, and parts and accessories thereof.

RE: The tariff classification of PTDial Armband for Epicondylitis from Canada

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Your item, also called a counterforce brace, has a non-elastic strap which is worn on the forearm near the elbow. Turning the dial makes the strap more or less snug in measured steps. The underlying purpose is to compress that part of the forearm and thus greatly restrict the movement of the underlying muscle tissue/tendons which have been injured/inflamed by repetitive use of the forearm muscles as in tennis or hammering nails. This enables them to heal more readily as well as reducing further injury.

Per ptdial.com, the minimum compression would normally be used when awake but not using the hand, the medium when doing light repetitive tasks, and firm when doing more strenuous tasks.

New York Ruling Letter 807584-119, 3-21-95, classified an epicondylitis bracelet in HTSUS 9021.19.85, which is equivalent to the current HTSUS 9021.10.00.

The applicable subheading for the PTDial Armband will be 9021.10.0090, Harmonized Tariff Schedule of the United States (HTSUS), which provides for “other” Orthopedic or fracture appliances, and parts and accessories thereof.

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