HS Code Classification of Spinal Implants>HS Code HS Classification

REF: Application for Advance Ruling for Spinal Implants

We are writing to request for an advance ruling  for Orthopaedic Spine Trauma Systems which are composed of Plates, Screws, Connecting Rods,  Connectors, Nuts,  Screws, Cage System, Hooks, Rods, Plate with Rod, Staples as, as per  section 248(A) of EACCMA.  Our proposed HS Classification is 9021.10.00.  In the writeup below, find, the analysis of the relevant Section Notes, Chapter Notes, Terms of Headings, Terms of subheadings that support our proposed Classification.  The structure of the analysis consists of extracts from the relevant legal notes, followed by our analysis, highlighted in grey. We propose an advance ruling of the components as systems,because the importation is done in parts.  In the analysis we will refer to them as Description Note 6.

Description of the Articles and Functions

(1)Occipital System

This is a grouping of the following components

• Plates
• Connectors
• Hooks
• Rods
• Screws
• Plate with Rod

(2)Cage System

This are several types of orthopaedic cages, including wedge cage, posterior lumbar Interbody fusion (pilif) cage,  transforaminal lumbar Interbody fusion (tilif) cage, expandable cage, mesh cage.

(3)Cervical System

This is a grouping of the following components

• Plates
• Screws
• Connecting Rods

(4)Pedicle System

This is a grouping of the following components

• Screws
• Connecting Rods
• Connectors
• Hooks
• Nuts
• Staple

(5)Screw System

This is a grouping of the following components

• Screws
• Nuts
• Connecting Rods

(6) Summary of Components forming all the Systems

1. Plates
2. Screws
3. Connecting Rods
4. Connectors
5. Nuts
6. Screws
7. Cage System
8. Hooks
9. Rods
10. Plate with Rod
11. Staple

Functions of the Articles Described in Note 6

Posterior short segment fixation is one of the most widely used surgical stabilization techniques for spinal fractures. The posterior spine is relatively easily accessible, and posterior fixation provides kyphosis correction, indirect reduction of canal encroachment, and stabilization of the fractured vertebra.

Pedicle screw fixation methods for traumatic fractures of the thoracic and lumbar spine

Thoracic and lumbar spine fractures are the most common injuries of the spine. An exaggerated curvature (kyphosis) at the end of treatment may predispose to later back pain and a poor functional outcome. If the nerve root or spinal cord is damaged, partial or complete loss of sensory and motor function in the legs, and urinary and faecal incontinence may result. Treatment depends on the individual characteristics of the fracture, with options including bed rest alone, closed reduction of the fracture and functional bracing, and surgery involving open reduction and internal fixation of the fracture. Surgery frequently involves posterior pedicle screw fixation, where typically screws are placed in the ‘pedicle’ parts of the vertebrae (bones of the spine) adjacent to the damaged vertebrae and connected by rods to hold the bones in place and stabilise the fracture while it heals. This review examined the evidence for the different types of pedicle screw fixation and for additional support such as fusion, where bone graft (usually taken from bone near the hip region of the patient) or substitute is added to the spine. The latter aims to reduce movement of the injured segment and any associated pain.

Vertebral fixation (also known as “spinal fixation”) is an orthopaedic surgical procedure in which two or more vertebrae are anchored to each other through a synthetic “vertebral fixation device”, with the aim of reducing vertebral mobility and thus avoiding possible damage to the spinal cord and/or spinal roots.

A vertebral fixation procedure may be indicated in cases of vertebral fracture, vertebral deformity, or degenerative vertebral disorders (such as spondylolisthesis).

Vertebral fixation devices

The device used to achieve vertebral fixation is usually a permanent rigid or semi-rigid prosthesis made of titanium; examples include rods, plates, screws, and various combinations thereof. A less common alternative is the use of a resorbable fixation device, composed of a bio-resorbable material.

The medical community uses several different techniques for stabilizing the posterior region of the spine. The most radical of these techniques is spinal fusion. In recent years/decades spinal surgeons have begun to rely more heavily on mechanical implants, which provide increased stability without so severely limiting the recipient’s range of motion. A number of devices have been developed that allow the recipients near natural range of motion while still providing some support. In many cases the support offered by such devices is insufficient, leaving the physician with few other choices than spinal fusion.

A spinal fixation device stabilizes an area of the posterior spine while allowing for a significant range of motion and limiting the compression of the affected vertebrae. The device consists of two or more arm assemblies (lateral) connected by one or more telescopic assemblies (vertical). Each arm assembly is composed of a central portion, which connects to the telescopic assembly or assemblies. Left and right arms attach to the corresponding side of the central portion of the arm assembly. Each arm section is directly connected to its individual pedicle by means of pedicle fasteners.

Chapter 90 Note 6.‑

For the purposes of heading 90.21, the expression “orthopaedic appliances” means appliances for :

–     Preventing or correcting bodily deformities; or

–     Supporting or holding parts of the body following an illness, operation, or injury.

Orthopaedic appliances include footwear and special insoles designed to correct orthopaedic conditions, provided that they are either (1) made to measure or (2) mass-produced, presented singly and not in pairs, and designed to fit either foot equally.

Implications of Chapter 90 Note 6

Chapter 90 Note 6, defines the precise meaning of Orthopaedic Appliances as per the Terms of Heading 90.21 and Terms of Subheading 9021.10.00.  This note is very important in the consideration of the type of the goods classifiable under subheading  9021.10.00.  The definition describes the functions of the items in the  Description Note 6 . This note supports the descriptions of the items done above, prevention, correction, support, holding but not replacement which would change the proposed classification.

Heading 90.21Explanatory Notes

90.21 ‑ Orthopaedic 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.

9021.10 – Orthopaedic or fracture appliances

9021.2- Artificial teeth and dental fittings :

9021.21 – – Artificial teeth

9021.29 – – Other

9021.3- Other artificial parts of the body :

9021.31 – – Artificial joints

9021.39 – – Other

9021.40 ‑ Hearing aids, excluding parts and accessories

9021.50 ‑ Pacemakers for stimulating heart muscles, excluding parts and accessories

9021.90 ‑ Other

(I) ORTHOPAEDIC APPLIANCES(Subheading 9021.10.00)

Orthopaedic appliances are defined in Note 6 to this Chapter.  These are appliances for :

–    Preventing or correcting bodily deformities; or

–    Supporting or holding parts of the body following an illness, operation, or injury.

They include :

(1)   Appliances for hip diseases (coxalgia, etc.).-

Coxalgia, also known as coxodynia, is defined as pain in the hip or disease-related pain of the hip.

(2)   Humerus splints (to enable use of an arm after resection), (extension splints).

A humerus shaft fracture may be treated with or without surgery, depending on the fracture pattern and associated injuries (i.e., nerve injury or open fracture). A temporary splint extending from the shoulder to the forearm and holding the elbow bent at 90 degrees can be used for initial management of the fracture.

(3)   Appliances for the jaw.

This applies to appliances to assist in the healing of jaw trauma

(4)   Traction, etc., appliances for the fingers.

This applies to appliances to assist in the healing of finger trauma

(5)    Appliances for treating Pott’s disease (straightening head and spine).

Pott disease is the most dangerous form of musculoskeletal tuberculosis because it can cause bone destruction, deformity, and paraplegia. Pott disease most commonly involves the thoracic and lumbosacral spine. However, published series have shown some variation.

(6)  Orthopaedic footwear and special insoles designed to correct orthopaedic conditions, provided that they are either (1) made to measure or (2) mass-produced, presented singly and not in pairs and designed to fit either foot equally.

Examples of Orthopaedic conditions:

• Common Orthopedic Disorders
• Rheumatoid Arthritis. Treatment for Arthritis.
• Cubital Tunnel Syndrome. Lateral Epicondylitis (Tennis Elbow) Medial Epicondylitis (Golfer’s or Baseball Elbow)
• Carpal Tunnel Syndrome.
• Ligament Injuries to the Knee. Torn Meniscus.

(7)   Dental appliances for correcting deformities of the teeth (braces, rings, etc.).

Note the ‘’correcting deformities’’.  Not replacement

(8)  Orthopaedic foot appliances (talipes appliances, leg braces, with or without spring support for the foot, surgical boots, etc.)

(9)    Trusses (inguinal, crural, umbilical, etc., trusses) and rupture appliances.

(10)  Appliances for correcting scoliosis and curvature of the spine as well as all medical or surgical corsets and belts (including certain supporting belts) characterised by :

(a)      Special pads, springs, etc., adjustable to fit the patient.

(b)      The materials of which they are made (leather, metal, plastics, etc.); or

(c)      The presence of reinforced parts, rigid pieces of fabric or bands of various widths.

The special design of these articles for a particular orthopaedic purpose distinguishes them from ordinary corsets and belts, whether or not the latter also serve to support or hold.

Scoliosis is where the spine twists and curves to the side.

Scoliosis is a sideways curvature of the spine that most often is diagnosed in adolescents. While scoliosis can occur in people with conditions such as cerebral palsy and muscular dystrophy, the cause of most childhood scoliosis is unknown.  This requires appliances to correct the curvature

(11)  Orthopaedic suspenders (other than simple suspenders of knitted, netted or crocheted materials, etc.).

This group also includes crutches and crutch‑sticks. (It should, however, be noted that ordinary walking‑sticks, even if specially made for disabled persons, are excluded (heading 66.02).)

This group further includes walking aids known as “walker-rollators”, which provide support for the users as they push them.  They generally consist of a tubular metal frame on three or four wheels (some or all of which may swivel), handles and hand-brakes.  “Walker-rollators” can be adjustable in height and can be equipped with a seat between the handles and with a wire basket for carrying personal items.  The seat allows the user to take short rest breaks whenever necessary.

This group also covers orthopaedic appliances for animals, for example, hernia trusses or straps; leg or foot fixation apparatus; special straps and tubes to prevent animals from crib‑biting, etc.; prolapsus bands (to retain an organ, rectum, uterus, etc.); horn supports, etc. But it excludes protective devices having the character of articles of ordinary saddlery and harness for animals (e.g., shin pads for horses) (heading 42.01).

Note the foot fixation apparatus, crib-biting prevention, horn supports, in animals.  When this kind of appliances are transposed to humans, they are the plates, screws and nails, rods etc which are described above

(II) SPLINTS AND OTHER FRACTURE APPLIANCES(Sub heading 9021.10.00)

Fracture appliances are used either to immobilise injured parts of the body (for extension or protection), or for setting fractures.  They are also used in the treatment of dislocations and other joint injuries.-

The description of the functions of the  plates, screws, nails, rods, staples, etc are precisely what is described by the above note.  Immobilise, setting fractures, dislocation treatment and treatment of joint injuries.  It does not cover joint replacement. The appliances are for treatment of injuries, deformities and disease caused deformities.

Some of these articles are designed for fitting onto the patient (e.g., wire, zinc or wooden cradles for holding limbs, plaster bandage splints, fracture appliances for ribs, etc.); others are designed to be fixed to a bed, a table or another support (protective bed cradles, extension fracture apparatus made of tubing, to be used in the place of splints or cradles, etc.).  However, when the latter appliances form an inseparable part of the bed, table or another support, they are excluded from this heading.

Note that the articles described by the note above are fitted onto the patient(external)eg, wire, zinc, wooden cradles for holding limbs, fracture appliances for ribs.  The point is in this case the appliances are external but serve the same purpose as described by the functions of the plates, screws and nails  Rods etc

Subject to the provisions of Note 1 (f) to this Chapter, the heading also includes plates, nails, etc., which are inserted inside the human body by surgeons to hold together the two parts of a broken bone or for similar treatment of fractures–

Note 1(f)  to chapter 90

Parts of general use, as defined in Note 2 to Section XV, of base metal (Section XV) or similar goods of plastics (Chapter 39);however, articles specially designed for use exclusively in implants in medical, surgical, dental or veterinary sciences are to be classified in heading 90.21;

As per the note above if the appliances are inserted into the human body to hold parts together, or similar treatment of fractures, then they are classifiable under subheading 9021.10.00

Take note that the above note covers  plates, nails, explicitly and similar articles which are the subject of this advance ruling request, which places them in subheading 9021.10.00

Further note the caveat in Note 1(f) of chapter 90, which places parts of general use including screws, rods, staples,  in heading 9021 if they are for medical, surgical sciences also places them under orthopaedic appliances in subheading 9021.10.00.

WCO Rulings on Subheading 9021.10

2. Screw designed for use in the field of trauma surgery, made of extra hard, colour-finished titanium alloy, of a length of approximately 12 mm. It has a wholly threaded shank with a constant outer diameter of 3 mm and a head. The shank has an asymmetrical thread. The head is also threaded, allowing it to lock into a compression plate in fixation systems, with a recessed socket drive. The product corresponds to the ISO/TC 150 standards for implant screws. It is presented in a sterilized packing. The product is marked with a number and thereby traceable throughout production, distribution, and use. Application of GIRs 1 and 6. Adoption : 2017
3. Screw designed for use in the field of trauma surgeryas a part of a system for posterior stabilization of the spine, made of extra-hard titanium alloy, of a length of 20 to 45 mm. It has a wholly threaded shank with a constant outer diameter of 4 mm and a dual core thread containing a transition zone for the core diameter change. It has also a self-tapping profile and a blunt, threaded tip. The product has a polyaxial (movable) U-shaped, internally threaded head that offers 25° of angulation around its axis allowing its adjustment and a specialized locking cap for fixing a rod (presented separately) in its head. The product corresponds to the ISO/TC 150 standards for implant screws. The product is marked with a number and thereby traceable throughout production, distribution and use.
   Application of GIRs 1 and 6.
   Adoption : 2017

Analysis of the WCO Rulings

Ruling 2 places screws. which are parts of general use as classifiable under subheading 9021.10.00.

The Screws are used in conjunction with compression plates, which also supports our assertion that the plates and similar trauma surgery articles are classifiable under subheading 9021.10.00

Note the use of the word systems,  The different parts have to be used together and that is the reason our description talks of systems.

Note the use of the term ‘’fixation systems’’. The implication is that articles for trauma surgery as described in Description Note 6 are for corrective, treatment, and do not replace the body parts

Note the term’’ part of a system for posterior stabilization of the spine’’.  This is the part of the functions of the articles described in Description Note 6. They are all for use in correcting spine issues. Remember you cannot replace the spine artificially.

Rulings from the European Union on subheading 9021.10

Reference of Ruling and Date	Description of the Goods
Ruling 1 FRBTIFR-BTI-2020-02688 05/29/2020- 05/28/2023	Orthopedic article in the form of a plate and self-drilling/self-tapping titanium screw system allowing anterior fixation of the cervical part of the spine. The anterior fixation plate is used in the context of traumatic (fracture for example) or degenerative pathologies. It allows osteosynthesis of one to several levels of the spine.
Ruling 2 FRBTIFR-BTI-2020-02461 29/05/2020- 28/05/2023	Orthopedic implant/prosthesis in the form of a filling cage of the lumbar or cervical intersomatic space in PEKK (Poly Ether Ketone Ketone), and titanium and / or tantalum marker depending on the model. The article will both restore the lordosis (curve) of the spine, offer a maximum contact area with the vertebral trays (uniform distribution of loads), and prevent micro movements thanks to a mechanical anchoring due to the grooves. The cage offers a structure to receive bone graft and thus allow the formation of a bone bridge after a few months between two vertebrae called fusion.
Ruling 3 FRBTIFR-BTI-2020-02671 09/06/2020- 08/06/2023	Posterior fixation system of the spine, for the thoracic and lumbar segments, allowing to achieve a structure stabilizing the treated parts of the spine. This system is composed of interconnected parts: screws with different functionalities, rods, hooks and different types of connectors. The pathologies treated by the system are: traumatic (fractures in particular), degenerative and deformities. Because of its versatility, the system makes it possible to adapt to different configurations to achieve posterior osteosynthesis. The devices making up the system are made of Titanium, and the rods can be made of Titanium and Chrome-Cobalt.
Ruling 4 FRBTIFR-BTI-2021-04450 24/06/2021- 23/06/2024	Set of surgical equipment, intended for the treatment of vertebral fractures. The item consists of sterile plastic implants (PEEK) packed in boxes, sterile and non-sterile accessories (spindle, catheters), a kit of tools and instruments made of stainless steel, titanium and aluminum. They are presented in a specially equipped container
Ruling 5 NLBTI2019-1044 06/11/2019- 05/11/2022	A so-called retro screw with – according to specification – the following technical characteristics and properties: – for use as an implant screw, which is applied during surgical operations; – of plastics; – complies with ISO/TC 150 standards; – threaded; – a length of 20 mm, – a diameter of 6 mm. The whole is offered sterile packaging
Ruling 6 Ref: NLBTI2019-1045 06/11/2019- 05/11/2022	A so-called cannulated interference screw with – according to specification – the following technical characteristics and properties: – for use as an implant screw, which is applied during surgical operations; – of titanium alloy; – complies with ISO/TC 150 standards; – threaded along the entire length; – a length of 30 mm, – a diameter of 7 mm. The whole is offered sterile packaged.

 

Analysis of Rulings from the European Union on the Classification under Subheading 9021.10.00

The items classifiable under subheading 9021.10.00 as per the EU are:

1)plate and self-drilling/self-tapping titanium screw system,

2)Orthopedic implant/prosthesis in the form of a filling cage of the lumbar or cervical intersomatic space

(3) Posterior fixation system of the spine, this system is composed of interconnected parts: screws with different functionalities, rods, hooks and different types of connectors. The pathologies treated by the system are: traumatic (fractures in particular), degenerative and deformities

(4) Articles intended for the treatment of vertebral fractures.

The articles correspond to those described in Description Note 6

The US Customs and Border Control HS Code Subdivisions for Heading 9021

Note that, the bone plates, screws, nails and other internal fixation devices are classifiable under subheading 9021.10.00 as per the US version of the HS

9021		Orthopaedic 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		Orthopaedic or fracture appliances, and parts and accessories thereof		Free		55%
9021.10.00	50	Bone plates, screws and nails, and other internal fixation devices or appliances	No.
9021.10.00	90	Other	No.
		Artificial teeth and dental fittings, and parts and accessories thereof:
9021.21		Artificial teeth and parts and accessories thereof:
9021.21.40	00	Of plastics	No.	Free		20%
9021.21.80	00	Other	No.	Free		70%
9021.29		Other:
9021.29.40	00	Of plastics	No.	Free		20%
9021.29.80	00	Other	No.	Free		70%
		Other artificial parts of the body and parts and accessories thereof:
9021.31.00	00	Artificial joints and parts and accessories thereof	No.	Free		55%
9021.39.00	00	Other	No.	Free		40%
9021.40.00	00	Hearing aids, excluding parts and accessories thereof	No.	Free		35%
9021.50.00	00	Pacemakers for stimulating heart muscles, excluding parts and accessories thereof	No.	Free [10]		35%
9021.90		Other:
9021.90.40		Parts and accessories for hearing aids and for pacemakers for stimulating heart muscles		Free		35%
9021.90.40	40	For hearing aids	No.
9021.90.40	80	Other	No.
9021.90.81	00	Other	No.	Free		35%

Rulings from The US Customs and Border Control on Subheading 9021.10.00

CLA-2-90:OT:RR:NC:N4:405-Ruling 1

RE: The tariff classification of spinal inserts from Germany.

The first category of merchandise consists of Intervertebral Body Fusion Devices. Medtronic has 8 varieties; the Capstone Peek Spinal Fusion System, the Clydesdale Spinal System, the Cornerstone PSR Spinal System, the Crescent Spinal System, the Perimeter Interbody Fusion Device, the Intrepid Spinal System, the Peek Prevail Cervical Interbody Device, and the Sovereign Spinal System.

The second category consists of Spinal Intervertebral Body Fixation Orthoses. Medtronic has 2 varieties: the Hourglass Vertebral Body Spacer, and the Vertestack Spinal System.

The third category consists of the Pedicle Screw Spinal System. Medtronic has one variety: the CD Horizon Spinal System.

All eleven items are inserted into the patient by surgeons to correct deformities of and/or to treat trauma to the spine. Harmonized System Explanatory Note II (Splints and Other Fracture Appliances) to 9021 states, “Subject to the provisions of Note 1 (f) to this Chapter, the heading also includes plates, nails, etc., which are inserted inside the human body by surgeons to hold together the two parts of a broken bone or for similar treatment of fractures.” This applies most closely to the CD Horizon Spinal System, which, you state, “consists of a variety of shapes and sizes of rods, hooks, screws, plates, staples, connecting components, and implant components that which can be rigidly locked into a variety of configurations, with each construct being tailor-made for the individual case.”

Regarding the other 10 items, they are more similar to natural vertebrae than the CD Horizon Spinal System is. In New York Ruling Letter R04596 – 105, September 11, 2006, we agreed with the inquirer that various vertebrae spacers were classified as artificial parts of the body in 9021.39.00, which provides for “Other” artificial parts of the body, and parts and accessories thereof.

Headquarters Ruling Letter H003713 – HkP, dated February 22, 2007, noting Note 1-f to Chapter 90, determined that certain screws which, when finished, were intended for use in the fixation of implants were not classified in 9021, HTSUS, but 7318. Without additional information about the screws included in several of these imports, we cannot determine if the screws here are “suitable for use only with” orthopaedic appliances or artificial parts of the body. However, in this case, the screws are only one element of each item, and we find that the only heading which describes all the non-subordinate elements of the imports is 9021, noting the principle in General Electric Company – Medical Systems Group vs. United States, 247 F.3d 1231 (Fed. Cir. 2001).

The applicable subheading for the CD Horizon Spinal System will be 9021.10.0050, Harmonized Tariff Schedule of the United States (HTSUS), which provides for Orthopaedic and fracture appliances, which are Bone plates, screws and nails, and other internal fixation devices or appliances. The rate of duty will be free.

The applicable subheading for the balance of the merchandise 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 rate of duty will be free.

Regarding all eleven items, we agree with your claim that a secondary classification will apply in HTSUS 9817.00.96 as specially designed or adapted for the use or benefit of the permanently or chronically physically or mentally handicapped (except articles for the blind

CLA-2-90:RR:NC:N1:105 R03684-Ruling 2

RE: The tariff classification of orthopaedic surgical cable and tools from Switzerland

We take it that the “1.0 mm Sternal Cable, 750 mm long, sterile (includes crimping ferrule and parallel end)” is typical of your “orthopaedic 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 orthopaedic 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 orthopaedic 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.

CLA-2-90:OT:RR:E:NC:4:405-Ruling 3

RE: The tariff classification of spinal fixation implants and surgical instruments

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 tumour. 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 orthopaedic 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 Orthopaedic and fracture appliances, which are Bone plates, screws and nails, and other internal fixation devices or appliances. The rate of duty will be free. 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.

CLA-2-90:OT:RR:NC:2:235-Ruling 4

RE: The tariff classification of a “Lateral Spine Truss System (LSTS)” from the Netherlands

In your letter dated May 31, 2017, you requested a classification ruling on a “Lateral Spine Truss System (LSTS).” In your letter, you describe the product at issue as a titanium implant, designed to provide mechanical support to the spine, while biologic fusion takes place. You further indicate that this implant is a vertebral interbody device, intended to facilitate fusion of one or two continuous levels in the spine in patients with chronic, painful, degenerative disease (DDD). It is intended to be used with autogenous bone graft material.

The applicable subheading for the “Lateral Spine Truss System (LSTS)” will be 9021.10.0050, Harmonized Tariff Schedule of the United States (HTSUS), which provides for Orthopaedic 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: Orthopaedic and fracture appliances, and parts and accessories thereof: Bone plates, screws and nails, and other internal fixation devices or appliances.

CLA-2-90 OT:RR:NC:N2:235-Ruling 5

RE: The tariff classification of interbody fusion devices from the Netherlands.

You have requested a classification for a Cervical Spine Truss System Interbody Fusion Device (Cervical STS), an Anterior Lumbar Interbody Fusion Device (ALIF STS), a Posterior Lumbar Interbody Fusion Spine Truss System (PLIF STS), an Oblique Transforaminal Lumbar Interbody Fusion Device Spine Truss System (OLIF STS) and a Transforaminal Lumbar Interbody Fusion Device Spine Truss System (TLIF STS). The Interbody Fusion Devices are titanium implants that are designed to provide mechanical support to the spine while biologic fusion takes place. The devices are implanted by surgeons in patients with degenerative disc disease and are intended to facilitate fusion of one or two contiguous levels in the lumbar spine. The devices have an “open architecture” design consisting of trusses designed to provide maximum support with the greatest amount of open space throughout the implant for bone growth and fusion.

The applicable subheading for the Cervical STS, the ALIF STS, the PLIF STS, the OLIF STS, and the TLIF STS will be 9021.10.0050, Harmonized Tariff Schedule of the United States (HTSUS), which provides for “Orthopaedic appliances, including crutches, surgical belts…which are worn or carried, or implanted in the body, to compensate for a defect or disability; parts and accessories thereof: Orthopaedic and fracture appliances, and parts and accessories thereof: Bone plates, screws and nails, and other internal fixation devices or appliances.” The general rate of duty will be Free.

CLA-2-90:OT:RR:NC:N4:405-Ruling 6

RE: The tariff classification of the Aspen Surgical Set from the United States

The Aspen Surgical Set is used to implant the Aspen Spinous Process System. Your submission describes this system as “a posterior, non-pedicle fixation device for placement in the lumbo-sacral spine. It is designed for plate attachment to spinous processes to achieve supplemental fusion in patients. The system helps to provide immobilization and stabilization for spinal segments as an adjunct to fusion of the lumbar or sacral spine.” The surgical set includes the titanium spinal implants, as well as the instruments required to attach the implants to the patient’s vertebrae.

The titanium implants and the instruments for the Aspen system have previously been ruled on in New York Ruling Letter N068586, mailed to you on August 5, 2009, classifying the surgical tools and the implants separately. In this most recent ruling request, you express the desire to obtain the classification of the items when shipped together as a set. In a telephone conversation with NISA E. Conceicao you stated that the Aspen Surgical Set consists of the implants and the surgical tools, packaged, shipped, and sold as a set.

GRI 3(b) states that sets for retail sale should be classified as if they consisted of the material or component which gives them their essential character, insofar as this criterion is applicable.

In your submission you suggest that the Aspen set be classified under HTS 9018.90.8000, in the belief that the surgical tools provide the essential character of the set.

Customs has previously taken the position that sets consisting of a medicament or medical implant and the tools to administer them have their essential character imparted by the medicament or implant, even if they do not predominate by bulk, weight, or value of the sets. This can be seen in Headquarters Ruling Letter 962506, December 17, 1999, and New York Ruling Letter J85317, June 25, 2003. In the latter ruling a set consisting of a coated stent and a stent delivery tool was found to have its essential character imparted by the stent. In the case of the Aspen Surgical Set, we believe the essential character is imparted by the titanium spinal implants.

The applicable subheading for the Aspen Surgical Set will be 9021.10.0050, Harmonized Tariff Schedule of the United States (HTSUS), which provides for Orthopaedic and fracture appliances, which are Bone plates, screws and nails, and other internal fixation devices or appliances

LA-2-90:OT:RR:NC:N4:405-Ruling 7

RE: The tariff classification of spinal inserts from Germany.

The first category of merchandise consists of Intervertebral Body Fusion Devices. Medtronic has 8 varieties; the Capstone Peek Spinal Fusion System, the Clydesdale Spinal System, the Cornerstone PSR Spinal System, the Crescent Spinal System, the Perimeter Interbody Fusion Device, the Intrepid Spinal System, the Peek Prevail Cervical Interbody Device, and the Sovereign Spinal System.

The second category consists of Spinal Intervertebral Body Fixation Orthoses. Medtronic has 2 varieties: the Hourglass Vertebral Body Spacer, and the Vertestack Spinal System.

The third category consists of the Pedicle Screw Spinal System. Medtronic has one variety: the CD Horizon Spinal System.

All eleven items are inserted into the patient by surgeons to correct deformities of and/or to treat trauma to the spine. Harmonized System Explanatory Note II (Splints and Other Fracture Appliances) to 9021 states, “Subject to the provisions of Note 1 (f) to this Chapter, the heading also includes plates, nails, etc., which are inserted inside the human body by surgeons to hold together the two parts of a broken bone or for similar treatment of fractures.” This applies most closely to the CD Horizon Spinal System, which, you state, “consists of a variety of shapes and sizes of rods, hooks, screws, plates, staples, connecting components, and implant components that which can be rigidly locked into a variety of configurations, with each construct being tailor-made for the individual case.”

Regarding the other 10 items, they are more similar to natural vertebrae than the CD Horizon Spinal System is. In New York Ruling Letter R04596 – 105, September 11, 2006, we agreed with the inquirer that various vertebrae spacers were classified as artificial parts of the body in 9021.39.00, which provides for “Other” artificial parts of the body, and parts and accessories thereof.

Headquarters Ruling Letter H003713 – HkP, dated February 22, 2007, noting Note 1-f to Chapter 90, determined that certain screws which, when finished, were intended for use in the fixation of implants were not classified in 9021, HTSUS, but 7318. Without additional information about the screws included in several of these imports, we cannot determine if the screws here are “suitable for use only with” orthopaedic appliances or artificial parts of the body. However, in this case, the screws are only one element of each item, and we find that the only heading which describes all the non-subordinate elements of the imports is 9021, noting the principle in General Electric Company – Medical Systems Group vs. United States, 247 F.3d 1231 (Fed. Cir. 2001).

The applicable subheading for the CD Horizon Spinal System will be 9021.10.0050, Harmonized Tariff Schedule of the United States (HTSUS), which provides for Orthopaedic and fracture appliances, which are Bone plates, screws and nails, and other internal fixation devices or appliances.

The applicable subheading for the balance of the merchandise 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.

CLA-2-90:RR:E:NC:N1:105 R04596-Ruling 8

RE: The tariff classification of Vertebral Spacers and other items from Switzerland

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 Orthopaedic 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 Orthopaedic and fracture appliances, which are Bone plates, screws and nails, and other internal fixation devices or appliances.

The following Support Documents: The link to them is:

https://drive.google.com/drive/folders/1zKjEngipvDNvK2bd_YFnQJrElxBwwNpb?usp=sharing

File Name	Item	Page
Advance Ruling Support Document 1	Orthopaedic Screws	4
Advance Ruling Support Document 1	Orthopaedic Plates	7
Advance Ruling Support Document 1	Interlocking Nails	13
Advance Ruling Support Document 2	Types of Fractures	17
Advance Ruling Support Document 2	Orthopaedic Trauma	18
Advance Ruling Support Document 2	Principles of Internal Fixation   Plates & Screws, Images of Insertion into the Human Body	19 Onwards
Advance Ruling Support Document 3	Interlocking Nails & Locking Bolts	18 Onwards
Video Link https://www.ypo.education/orthopaedics/spine/minimally-invasive-pedicle-screw-instrumentation-t170/video/	Video Explains the Treatment of Spine Trauma as well as the Application of Articles Listed for this Advance Ruling

The product catalogues  illustrate the type of goods to be imported and their functions. We have listed rulings from the World Customs Organisation,  European Union, and the US Customs and Border Control to provide a guide on the type of items classifiable under subheading 9021.10. The  rulings are not binding on KRA. They are only indicative.

We will therefore be very grateful for your concurrence with our proposed HS Classification

Yours faithfully

Janron Consult

KRA agreed with our proposed classification of 9021.10 which does not attract import duty and VAT instead of 9021.90, which attracts VAT

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Janron Consult, Tax Consultant Kenya, Customs Tax Consultant Kenya, Tax Advisory Kenya

Talk to Janron Consult for the following:

Ministry of Health Exemptions

Treasury Exemptions

Advance Ruling Application to KRA

Objection to KRA Rulings on Customs Value

Objections to KRA Rulings on HS Classification