Spinal Implant Classified as Artificial Body Part, Not Orthopaedic Appliance: CAAR

In re India Medtronic Private Limited (CAAR Delhi)

In Customs Authority of Advance Rulings, Delhi, the Authority examined the correct customs classification of PYRAMESH Implant Mesh, a titanium vertebral body replacement device imported for spinal surgeries. The applicant sought clarity between tariff sub-headings 9021.10.00 (orthopaedic or fracture appliances) and 9021.39.00 (other artificial parts of the body). After analysing the product’s design, material composition, implantation procedure, and function, the Authority held that PYRAMESH does not merely support or hold existing body parts but replaces an absent vertebral body following complete excision due to trauma, tumors, or disease. Relying on Chapter 90 Notes, WCO Explanatory Notes, and the General Rules for Interpretation, the Authority concluded that devices which permanently replace anatomical structures qualify as “artificial parts of the body.” Since PYRAMESH fills the structural void and becomes the vertebral body through osseointegration, it was ruled to be correctly classifiable under tariff entry 9021.39.00, rejecting classification as an orthopaedic appliance under 9021.10.00.

FULL TEXT OF THE ORDER OF CUSTOMS AUTHORITY OF ADVANCE RULING, DELHI

M/s India Medtronic Private Limited located at 4th Floor, SAS Tower, Sector 38, Medanta Hospital, Gurugram, Haryana-122001 having IEC No. 3496003171 and PAN- AAACI4227Q (the applicant, in short) filed an application in Form CAAR-1 before the Customs Authority for Advance Rulings, New Delhi (CAAR, in short) for seeking advance ruling. The complete application was received in the Secretariat of the CAAR, New Delhi on 02.09.2025 along with their enclosures in terms of Section 28 H (1) of the Customs Act, 1962 (hereinafter referred to as the ‘Act’).

1.1. The applicant’s submissions are as given below:

1.2. M/s India Medtronic Private Limited having office at 4th Floor, SAS Tower, Sector 38, Medanta Hospital, Gurugram, Haryana-122001, holding IEC number 3496003171, arc engaged in the trading and distribution of medical devices and technologies, providing solutions in areas such as heart care, surgery, brain and spine conditions, and diabetes management.

1.3. In order to undertake its operation in India, the Applicant is importing PYRAMESH Implant Mesh (hereinafter referred to as ‘product’ or ‘product under consideration’ or ‘product in question’) for use in Medical and surgical procedure. It is a cylindrically shaped, implantable spinal device intended for use in the thoracolumbar spine (T1 to L5) to restore vertebral body height lost due to tumors or fractures.

1.4. The Applicant has approached the Customs Advance Rulings Authority for determining the classification of PYRAMESH Implant mesh, this product is imported under various material numbers and descriptions, yet all serve a similar function under the general category of Paramesh Spinal mesh. The following items mentioned in table below can be identified as Paramesh Spinal mesh, sharing common features and functionalities that are essential for determining their appropriate classification:

CFN	Material	Material Description
905-101	00673978080567	MESH 905-101 PYRM 10MM X 100MM ROUND
905-103	00673978080574	MESH 905-103 PYRM 10MM X 30MM ROUND
905-107	00673978080581	MESH 905-107 PYRM lOMM X 70MM ROUND
905-110	00673978080604	MESH 905-110 PYRM 10MM X 10MM ROUND
905-133	00673978080642	MESH 905-133 PYRM 13MM X 30MM ROUND
905-137	00673978080659	MESH 905-137 PYRM 13MM X 70MM ROUND
905-163	00673978080680	MESH 905-163 PYRM I 6MM X 30MM ROUND
905-166	00673978080697	MESH 905-166 PYRM 16MM X 60MM ROUND
905-194	00673978080703	MESH 905-194 PYRM 19MM X 40MM ROUND
905-199	00673978080727	MESH 905-199 PYRM 19MM X 90MM ROUND
905-256	00673978080772	MESH 905-256 PYRM 25MM X 60MM ROUND
905-901	00673978081281	MESII 905-901 PYRM 13MM X 130MM CURVED
905-902	00673978081298	MESH 905-902 PYRM 10X14 OVOIDX130MM CRV
9051050	00681490484473	MESH 9051050 PYRAMESH IMP IOMMX5OMM RND
9051690	00681490484527	MESH 9051690 PYRM IMPLANT 16MMX90MM RND
9051770	00681490484589	MESH 9051770 PYRAMESH 17MMX22MMX7OMM

1.5. It is submitted that even though detailed description and product numbers are different, all the goods answer to the product name of “PYRAMESH Implant mesh”. All the goods are similar in nature i.e., titanium mesh devices designed for spinal reconstruction and functions in the similar way. They differ only in shape and size, ranging from round and ovoid to curved and rectangular, to accommodate various anatomical regions and surgical requirements, from cervical to thoracolumbar applications. These variations do not appear to influence the classification of the product under consideration. Therefore, a single application is being submitted to request a ruling on their appropriate classification.

1.6. It is further submitted that company has received an order pertaining to the ParietexTm Composite Mesh- inguinal hernia mesh which is significantly different from “PYRAMESH Implant Mesh” – a spinal implant, for which advance ruling is being sought from your authority. The ParietexTm Composite Mesh is a microporous polyester textile that promotes tissue integration on one side and features a collagen-based absorbable film on the other to minimize visceral adhesions. This dual-sided surgical mesh is particularly suitable for intraperitoneal placement during procedures such as hiatal or incisional hernia repairs. In contrast, the PYRAMESFITm Implant Mesh is a titanium-based mesh primarily used in spinal surgeries, particularly for vertebral body replacement in the thoracolumbar spine (II—LS). It is made from commercially pure titanium, offering high strength, biocompatibility, and excellent imaging properties. Its design includes contoured edges and integral rings to reduce deformation and facilitate smooth insertion.

Product applications. functions. and other technical capabilities

1.7. As explained above, The PYRAMESHTM implant is a cylindrically-shaped, non-expandable interbody vertebral body replacement (VBR) device, intended for use in the thoracolumbar spine (T1—L5). It is designed to replace and restore the height of a diseased or damaged vertebral body resulting from trauma (e.g., fracture) or tumor resection. The device is intended only for use with supplemental spinal fixation systems that are cleared or approved for thoracolumbar application. It is available in a range of heights and diameters to accommodate various patient anatomies.

1.8. Design Features:

1.8.1 The product has hollow central lumen extending throughout the longitudinal axis, allowing for the packing of bone graft material (either autograft or allograft, at the surgeon’s discretion).

1.8.2. It has open ends and integrated pyramid-shaped fenestrations on the lateral walls to promote bone graft containment, vascularization, and eventual bony fusion through the implant.

1.8.3 Also, it has contoured endplates engineered to engage the adjacent vertebral endplates and provide resistance to implant migration or expulsion under physiological loading conditions.

1.9. Material Composition

This implant is manufactured from pure titanium and titanium alloy conforming to applicable biocompatibility and material standards (e.g., ASTM F67 and ASTM F136).

1.10. Indications for Use:

The PYRAMESHTM implant is indicated for vertebral body replacement in the thoracic and lumbar spine (T1—L5) to:

• Stabilize the spine.
• Restore vertebral body height.
• Support load bearing through the anterior spinal column.

1.11. Implantation Procedure for PYRAMESIirm Implant:

• The graft-packed implant is inserted into the prepared vertebral defect using a dedicated surgical inserter.
• The implant is positioned under fluoroscopic guidance to ensure accurate alignment in the sagittal and coronal planes.
• The contoured ends of the implant are seated firmly against the superior and inferior vertebral endplates to provide initial mechanical stability and resistance to migration or expulsion.
• Following placement of the PYRAMESHTM implant, supplemental spinal fixation (such as a pedicle screw-rod system) is applied.
• Supplemental fixation is essential to ensure construct stability during the bone healing and fusion process. The PYRAMESHTM implant is not intended for stand-alone use.

1.12. Product Image:

1.13. A brochure detailing the technical specifications and functional capabilities or the product under consideration, along with representative 2D images, is enclosed.

1.14. Chain of events leading to the present Application:

1.14.1 The applicant has been importing the product under consideration-PYRAMESH Implant mesh into India classifying the same under sub-heading 9021.10.00 of the First Schedule to the “Indian Customs Tariff Act, 1975. This subheading pertains to Orthopaedic appliances typically used for external support or immobilization. However, the classification adopted by the applicant presents a degree of ambiguity, particularly in light of the competing subheading 9021.39.00, which also covers product of similar nature and functionality.

1.14.2. Subheading 9021.39.00 specifically covers “other artificial parts of the body.” According to the World Customs Organization (WCO) HSN Explanatory Notes, this category includes devices that wholly or partially replace defective or damaged anatomical structures and are designed to replicate both the form and function of the natural body part. The product in question is a permanent, implantable spinal device intended to restore structural integrity and physiological function to the vertebral column, aligning closely with the scope of subheading 9021.39.00.

1.14.3. Given the product’s implantable nature and its role in anatomical and functional restoration, a detailed analysis is required to determine the most appropriate classification between these two competing tariff entries.

1.14.4. In view of the preceding analysis, it is evident that a plausible classification overlap exists between sub-heading 9021.10.00, which broadly encompasses orthopedic appliances intended for external support or correction, and sub-heading 9021.39.00, which more specifically pertains to implantable artificial parts of the body. This overlap arises perhaps due to the evolving nature of medical technologies, where certain devices may exhibit characteristics relevant to both categories.

1.14.5. To address this ambiguity, the present application seeks to undertake a reasoned and systematic interpretation of the relevant tariff entries. This involves a comparative analysis of the scope, legal notes, and explanatory guidance associated with each heading, in accordance with the General Rules for the Interpretation of the Harmonized System (GM) and applicable legal provisions under the Indian Customs Tariff framework. The objective is to determine the most accurate and legally sound classification for the product under consideration, ensuring consistency with international standards and interpretative principles.

HSN currently used by the Proposed HSN Applicant

Tariff entry 9021 10 00 9021 39 00

Heading Description Orthopedic or fracture appliances Other artificial parts of the body

– – – Other

BCD 7.5% 7.5%

1.14.6. It is pertinent to note that the applicable rate of customs duty for both competing tariff entries remains the same. Consequently, the issue of classification in this case is revenue neutral and does not impact the overall duty liability.

1.14.7. In light of the foregoing analysis, the applicant respectfully approaches this Hon’ble Authority to seek clarity on the appropriate classification of the PYRAMESH Implant mesh, which is used to replace damaged vertebral bone structures.

1.14.8. The Applicant’s detailed submissions and prayer in relation to the classification question are set out in the following paragraphs for the Authority’s kind consideration.

Statement containing the Applicant’s interpretation of law and facts in respect of the aforesaid question(s)

General Rules of Interpretation

1.15. The classification of goods under the Indian Customs Tariff is governed by the General Rules of Interpretation (GRI).

1.15.1. Rule 1 of the WCO’s General Rules of Interpretation states that customs classification is based on the terms of headings and relevant Section or Chapter Notes, not on titles, which serve only as reference and have no legal standing.

Rule 1: “The titles of Sections, Chapters and sub-Chapters are provided for ease of reference only; for legal purposes, classification shall be determined according to the terms of the headings and any relative Section or Chapter Notes and, provided such headings or Notes do not otherwise require, according to the following provisions.”

1.15.2. Rule 6 further clarifies that the classification of goods within subheadings must be determined by the terms of those subheadings and any related notes. This rule applies mutatis mutandis to the preceding rules, with the understanding that only subheadings at the same hierarchical level are comparable. Section, Chapter, and subchapter notes also apply unless the context dictates otherwise.

Rule 6: “For legal purposes, the classification of goods in the subheadings of a heading shall be determined according to the terms of those subheadings and any related subheading notes and, nuaatis mutandis, to the above rules, on the understanding that only subheadings at the same level are comparable. For the purposes of this rule, the relative section, chapter and subchapter notes also apply, unless the context otherwise requires.”

1.16. Classification of the product under consideration under CTH 9021.

Chapter 90 of the Indian Customs Tariff Act encompasses a broad spectrum of instruments and apparatus used in scientific, medical, optical, and technical domains. These include optical instruments (e.g., lenses, prisms, microscopes), photographic and cinematographic equipment (e.g., cameras, projectors), measuring and checking instruments (e.g., thermometers, pressure gauges), precision tools, and medical or surgical devices (e.g., syringes, diagnostic instruments). The chapter also includes parts and accessories associated with these instruments. Relevant extract of chapter 90 description is reproduced below for reference:

Chapter 90

Optical, photographic, cinematographic, measuring checking, precision, medical or surgical
instruments and apparatus, parts and accessories thereof

1.17. The relevant heading under consideration, HS Code 9021, specifically covers orthopedic appliances and medical devices intended to compensate for physical disabilities or defects. As per the Explanatory Notes issued by the World Customs Organization (WCO), this heading includes crutches, surgical belts, trusses, splints, and other fracture appliances. It also encompasses artificial parts of the body, such as limbs and joints, as well as hearing aids and similar devices that arc worn, carried, or implanted in the body.

The relevant description of Heading 9021 is reproduced below for reference:

Orthopedic appliances, including crutches, surgical belts and trusses; splints and other fi^–acuter 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.

1.18. Therefore, in accordance with General Rules of Interpretation (CR1), classification must be based on the terms of the headings and relevant notes. Given that Heading 9021 explicitly includes orthopedic as well as artificial parts of the body and prosthetic implants, the product under consideration clearly falls within the scope of this heading. The nomenclature provides a direct and unambiguous basis for classification, thereby the product squarely falls within the scope of heading 9021.

1.19. For case of reference, the relevant extract of the Schedule 1 to the Customs Tariff Act, 1975 has been provided below:

Tariff code	Description of Goods
Chapter 90	Optical, photographic, cinematographic, measuring checking, precision, medical or surgical instruments and apparatus, parts and accessories thereof
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 arc worn or carried, or implanted in the body, to compensate for a defect or disability.
9021 10 00	-Orthopedic or fracture appliances -Artificial teeth and dental fittings -Other artificial parts of the body:
9021 31 00	— Artificial joints
9021 39 00	–Other

1.20. According to the World Customs Organization’s Explanatory Notes for Chapter 90, the term “orthopedic appliances” under Heading 9021 refers to devices that serve two primary functions: first, to prevent or correct physical deformities, and second, to provide support or stabilization to parts of the body that have been affected by illness, surgery, or injury. Relevant extract of WCO Explanatory Notes to Chapter 90 is reproduced below for reference:

The term “orthopedic appliances” of heading 9021 refers to devices used for:

• Preventing or correcting bodily deformities; or
• Supporting or holding parts of the body following illness, operation, or injury.

1.21. This interpretation indicates that Customs Tariff Heading (CTH) 9021.10 specifically includes appliances designed with the intent to either correct structural abnormalities or assist in the recovery process by supporting weakened or healing body parts. These devices are essential in medical rehabilitation, as they contribute significantly to restoring mobility, enhancing physical function, and facilitating the healing process.

1.22. According to the World Customs Organization (WCO) Explanatory Notes to Heading 9021, subheading 9021.39 pertains to “other artificial parts of the body.” This includes devices that wholly or partially replace defective or missing anatomical structures and are typically designed to replicate both the form and function of the natural body part. Section III(C) of the Explanatory Notes explicitly lists examples such as artificial limbs, joints, and synthetic tubes for replacing blood vessels and heart valves—highlighting the inclusion of implantable prosthetic devices. Relevant extract from the explanatory notes is reproduced below for reference:

EN 9021(111) (C) covers:

(III) Artificial Limbs, Eyes. Teeth and Other Artificial Parts of The Body

These wholly or partially replace defective parts of the body and usually resemble them in appearance.

(C) Other artificial parts of the body, e.g., arms, forearms, hands, legs, feet, noses, artificial joints (e.g., for hips, knees), and tubes of synthetic fabric for replacing blood vessels and heart valves.

1.23. Copy of the explanatory notes of 9021 is attached.

1.24. Here’s a comparison table between 9021 10 vs 902139 basis above explanatory notes:

Feature	HS Code 902110	HS Code 902139
Description	Orthopedic Or fracture	Artificial parts of the body (excluding joints and limbs)
Purpose	Support or immobilize body parts during recovery	Replace or assist body functions due to disability
Examples	Crutches, splints, braces, surgical belts	Hearing aids, pacemakers, dental implants
Implantable/Wearable	Mostly wearable or external	Often implantable or worn inside the body
Medical Use	Used for temporary or long-term physical support	Used for permanent or semi- permanent body function aid
Customs Classification	Focused on structural support devices	Focused on functional replacement devices

1.25. The PYRAMESH Spinal Mesh is an implantable medical device specifically designed to replace or support damaged spinal tissue resulting from traumatic injury, degenerative conditions, or oncological resection. It is manufactured from biocompatible titanium, the device offers mechanical strength, corrosion resistance, and long-term compatibility with human physiological systems, making it suitable for permanent implantation within the body.

1.26. Unlike orthopedic appliances classified under HS Code 9021.10, which are typically external, non-invasive devices used for temporary support or immobilization, Paramesh flections as a prosthetic substitute for damaged spinal components. It is surgically implanted into the spine to restore structural integrity, support vertebral alignment, and facilitate spinal fusion. As such, it does not merely support or immobilize externally but replaces part of the spinal anatomy, aligning with the definition of artificial body parts under HS Code 9021.39.

1.27. According to the above explained World Customs Organization (WCO) Explanatory Notes to Heading 9021, subheading 9021.39 pertains to “other artificial parts of the body,” which includes devices that wholly or partially replace defective anatomical structures. These devices are classified under this heading when they are designed to replicate the structural and functional characteristics of the natural part being replaced.

1.28. Given its design, material composition, and therapeutic purpose, the PYRAMESH spinal implant clearly meets the criteria for classification under sub-heading 9021.39.00 of the First Schedule to the Customs Tariff Act, 1975, which covers “Other: Other artificial parts of the body.” Therefore, its classification under sub-heading 9021.39 is appropriate, as it reflects both the implantable nature of the device and its function as an artificial part of the body.

1.29. In this regard, reliance is also placed on the U.S. Customs and Border Protection (CBP) Ruling No. R04596, wherein a similar implantable mesh device referred to as Symens spacers manufactured from biocompatible titanium material, was classified under Heading 9021 39 00. The CBP recognized that such devices, intended for implantation to replace or support spinal structures, fall within the scope of ‘other artificial parts of the body.’ This classification lends persuasive value in support of classifying the PYRAMESH Spinal Mesh under FISN Code 9021 39 00 of the Indian Customs Tariff Copy of the ruling is herein enclosed as Annexure 3.

1.30. In conclusion, the Applicant respectfully submits that the product under consideration-PYRAMESH Spinal Mesh-is most appropriately classifiable under Customs Tariff Sub-Heading (CTSFI) 9021.39.00, based on the following grounds:

• PYRAMESH is a surgically implanted spinal mesh made of biocompatible titanium, specifically designed to replace or support damaged spinal structures.
• in accordance with General Rules of Interpretation (GRI) 1 and 6, classification must be determined by the terms of the headings and relevant Section or Chapter Notes. Heading 9021 covers medical or surgical instruments and devices, which includes implantable devices.
• Subheading 9021.10 pertains to external orthopedic appliances used for temporary support or immobilization. As Paramesh is a permanent internal implant, it does not fall within the scope of this subheading.
• The World Customs Organization (WCO) Explanatory Notes to Heading 9021, particularly Section III(C), explicitly include implantable prosthetic devices under subheading 9021.39 as “other artificial parts of the body.”
• Therefore, by application of GR1 1 and 6, PYRAMESH is correctly classifiable under HS Code 9021.39, which encompasses implantable devices that function as artificial body parts.

1.31. Whether the question(s) raised is pending in the applicant’s case before any officer of Customs, Appellate Tribunal, or any Court of Law?

The Applicant respectfully submits that no question or issue pertaining to the classification of the subject product, i.e., PYRAMESH Spinal Mesh, is pending for consideration before any officer of Customs, the Appellate Tribunal, or any Court of Law, in the Applicant’s case.

In light of the facts, relevant legal provisions and our submissions made in the above paragraphs, our humble prayer before your good self is as follows:

Confirm that the product under consideration is classifiable under tariff entry 9021 39 00 as Other; Other artificial parts of the body; and

Allow us to present our case in a personal hearing before your good self-prior to issuance of any Order.

2. Comments of the Port Commissionerate:

2.1 As per the provision of CAAR Regulation, 2021, the complete application of the applicant was provided to the concerned Custom Port, and requested to furnish the requisite comments in the instant matter. The port authority vide letter dated 30.10.2025 furnished its comments, as follows:

2.1.1. Eligibility of the applicant, in terms of section 28-E (c) of the Customs act, 1962 to seek such advance ruling.

The Importer is having IEC CODE: 3496003171 hence is eligible in terms of c(i).

2.1.2. Applicability of proviso (1) of section 28-1 (2) of the Customs Act, 1962 regarding the question raised in the application

As per the available records the specific matter is not pending in any appellate tribunal or Court.

2.1.3. Specify whether the claim of the applicant regarding the nature of activity, i.e. it is ongoing/ proposed is correct: and

The importer has stated vide letter dated 25.06.2025 they have been importing the product under consideration under 90211000. However, upon perusal of import data from 01.04.2020 to 28.10.2025 it is seen that the importer has imported the item “00673978080567 MESH 905-101 PYRM 10MM X 100MM Round” only on 17.09.2025 vide BE 4560027 dated 17.09.2025. Warehouse) at INMAA4 under CTI 90211000. Further vide BE 5099656 dt. 14.10.2025, 5261358 dt. 23.10.2025, 5284175 dt. 24.10.2025, 5337568 dt. 27.10.2025 also the importer has imported the said goods under 90211000.Hence on the date of application the import was not on-going in INMAA4 however as on date i.e. 28.10.2025 the import is on-going.

2.2. Comments on the merits of the question raised in the application, along with all materials in support thereof.

2.3. THE PRODUCT – PYRAMESHTM IMPLANT MESH

The importer vide letter dated 25.06.2025 has submitted the following regarding the product in para 6:

2.3.1. PYRAMESHTM Implant is a cylindrically shaped, non-expandable vertebral body replacement device manufactured from pure titanium and titanium alloy (ASTM F67/F136). The device features a hollow central lumen for bone graft packing and pyramid-shaped fenestrations on lateral walls that promote bone containment, vascularization, and eventual bony fusion. Contoured endplates are engineered to engage adjacent vertebral endplates and resist migration. Available in various heights (10-90mm) and diameters (10-70mm), the device is specifically indicated for vertebral body replacement in the thoracolumbar spine (T1-1,5).

2.3.2. The clinical indication for PYRAMESH is complete surgical removal of an entire vertebral body due to primary or metastatic tumors, severe traumatic destruction, or osteomyelitis. The surgical procedure involves: (1) complete excision of the diseased vertebral body, creating a structural void in the spinal column; (2) packing PYRAMESH with autograft or allograft bone material; (3) inserting the graft-packed implant into the vertebral defect under fluoroscopic guidance; (4) seating the contoured ends against the superior and inferior endplates of adjacent vertebrae; and (5) applying supplemental pedicle screw-rod fixation. The product documentation explicitly states: “The PYRAMESHTm implant is not intended for stand-alone use. Supplemental fixation is essential to ensure construct stability during bone healing and fusion process.”

2.3.3. Over 6-12 months post-surgery, bone graft consolidates and grows through the PYRAMESH fenestrations, creating a titanium-bone composite structure that permanently integrates into the spinal column through osseointegration. The medical profession consistently terms PYRAMESH as a “Vertebral Body Replacement device, “VBR implant,” or “Corpectomy cage”-terminology that emphasizes its replacement function rather than support function.

2.4. CIT 90211000-“ORTHOPAEDIC OR FRACTURE APPLIANCES” Heading 9021 of the Customs Tariff Act, 1975 covers 9021 10 00: “Orthopedic or fracture appliances.”

Note 6 to Chapter 90 provides the statutory definition for Orthopaedic appliances

6. For the purpose of heading 9021, the expression “orthopedic appliances” means appliances for: (1) preventing or correcting bodily deformities: or

(ii) supporting or holding parts of the body following an illness, operation or injury. Orthopedic appliances include footwear and special insoles designed to correct Orthopaedic conditions. provided that they arc either (1) made to measure, or (2) mass produced, presented singly and not in pairs and designed to fit either foot equally.

2.5. As seen from the above Orthopaedic appliances are those appliances which prevent or Correct Bodily Deformity And support or hold parts of the body following operation or injury.

2.6. Further light can be shed on Orthopaedic appliances from the WCO Harmonized System Explanatory Notes which is as below:

(1) ORTHOPAEDIC APPLIANCES

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.).

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

(3) Appliances for the jaw.

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

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

(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.

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

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

(9) Trusses (inguinal, aural. 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 arc 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 tatter also serve to support or hold.

(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 scat between the handles and with a wire basket for carrying personal items. The scat allows the user to take short rest breaks whenever necessary.

2.7. Serial No 10 for correction of spine is as, scoliosis posture corrector appliance is as below which is not relevant.

2.8. Hence the WCO gives examples of Orthopaedic appliances which includes including crutches, surgical belts, trusses, and splints. As it can be seen most of the said examples arc external support elements and not implants.

2.9. The FRACTURE APPLIANCE which are also Orthopaedic appliance have been described in the WCO explanatory notes as below:

(II) SPLINTS AND OTHER FRACTURE APPLIANCES

Fracture appliances are used either to immobilize 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.

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.

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.

Fracture appliances are used to immobilise injure parts or used for setting fractures.

2.10. It is also mentioned that this heading includes plates, nails which are instated inside the human body to hold together two parts of a broken bone or similar treatment of fractures. This indicating that Orthopaedic appliances are not limited to external or removable devices.

2.11. From the above it is observed that this sub-heading covers devices:

• whether external or implanted
• function to support, hold, stabilize, prevent, or correct existing anatomical structures.
• The common characteristic is that these devices work with existing body parts to facilitate healing, provide support, or correct deformities.

2.12. Applicability to PYRAMESH

PYRAMESH could be argued to satisfy Note 6’s criteria – it prevents spinal deformity (prevents collapse, maintains alignment) and could be characterized as supporting/holding vertebrae following operation. The heading permits implanted devices, so permanent implantation does not disqualify it. It could be characterized as a specialized fracture appliance since it is indicated for vertebral fractures. It requires supplemental pedicle screw-rod fixation, suggesting it functions as a component within an Orthopaedic fixation system where the screws/rods (classified 9021 10 00) provide stabilization. However, the fundamental functional pattern of 9021 10 00 items is that they work with existing anatomical structures. Bone plates hold existing bone fragments together; intramedullary rods stabilize existing fractured bone; pedicle screws support existing vertebrae. In PYRAMESH’s application, the middle vertebral body is completely removed – there is no existing vertebral structure

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.

Subject to the provisions of Note I (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.

(III) ARTIFICIAL LIMBS, EYES, TEETH
AND OTHER ARTIFICIAL PARTS OF THE BODY

These wholly or partially replace defective parts of the body and usually resemble them in appearance. They include

(A) Artificial ocular fittings :

(1) Artificial eyes. These are usually made of plastics or glass to which small quantities of metallic oxides have been added in order to imitate the features and colouring of the various parts of the human eye (sclera, iris, pupil). They may be of single or of double shell types.

(2) Intra-ocular lenses.

Artificial eyes for tailors’ dummies, for furs, etc., are excluded (generally classified in heading 39.26 or 70.18); artificial eyes identifiable as parts of dolls or of toy animals fall in heading 95.03 or in heading 70.18, if they are of glass.

B. Artificial teeth and dental fittings, for example :

(I) Solid artificial teeth, usually made of porcelain or plastics (acrylic polymers in particular). These may be “diatoric” teeth having a small number of holes into which the fixing material penetrates (generally molars), or may be fitted with two metallic pins for fixing (generally incisors and canines) or with a groove for sliding on to a metal ridge fixed to the dental plate (also usually incisors and canines).

(2) Hollow artificial teeth, also made of porcelain or plastics and with the external shape of teeth (incisors, canines or molars).

According to the method of fixing, they are called “pivot teeth” (placed on a small metallic pin or pivot fitted into the prepared root), or “crowns” (fitted by means of artificial resin on to a previously shaped stump).

Dentures, whole or part, comprising a plate of vulcanised rubber, plastics or metal to which the false teeth are fitted.

(3) Other articles such as, prefabricated metal crowns (gold, stainless steel, etc.) used for in creasing

the protection of real teeth; cast tin bars (“heavy bars”) for weighting and the stability of dentures; stainless steel bars for reinforcing vulcanised rubber dental plates; various other dentists’ accessories, clearly identifiable as such, for making metal crowns or dentures (sockets, rings, pivots, hooks, eyelets, etc.).

It should be noted that dental cements and other dental _.fillings fall in heading 30.06; the preparations known as “dental wax” or as “dental impression compounds”, put up in sets, in packings for retail sale or in plates, horseshoe shapes, sticks or similar forms, and other preparations for use in dentistly, with a basis of plaster (of calcined gypsum or calcium sulphate), fall in heading 34.07.

(C) Other artificial parts of the body, e.g., arms, firearms, hands, legs, feet, noses, artificial joints (e.g., for hips, knees), and tubes qfsynthetic_.fabric for replacing blood vessels and heart-valves. The heading excludes pieces of bone or skin for grafting, in sterile containers (heading 30.01) and bone reconstruction cements (heading: (heading 30.06)

(IV) HEARING AIDS

These are generally electrical appliances with a circuit containing one or more microphones (with or without amplifier), a receiver and a battery The receiver may be worn internally or behind the ear, or it may be designed to be held in the hand against the ear

This group is restricted to appliances for overcoming deafness; it therefore excludes articles such as headphones. amplifiers and the like used in conference rooms or by telephones to improve the audibility of speech .

(V) OTHER APPLIANCES WHICH ARE WORN OR CARRIED, OR IMPLANTED IN THE
BODY, TO COMPENSATE FOR A DEFECT OR DISABILITY

This group includes:

(1) Speech-aids for persons having lost the use of their vocal cords as a result of an injury or a surgical operation. These consist essentially of an electronic impulse generator When pressed against the neck, Jiff example, they generate vibrations in the cavities of the throat which are modulated by the user to produce audible speech.

(2) Pacemakers fbr stimulating defectives heart muscles. These arc roughly the size and weight of a pocket watch and are implanted beneath the skin of the patient’s chest. They incorporate an electric battery and are connected by electrodes to the heart, which they provide with the impulses necessary birr its litnctioning. Other types _of pacemakers are used to stimulate other organs (for example, the lungs, the rectum or the bladder).

(3) Electronic aids for the blind. These consist essentially of an ultrasonic transnziller-receiver powered by an electric battery. The frequency variations resulting from the time taken for the ultrasonic beam to travel ow to an obstacle and be reflected back enable the uso; through an appropriate device (e.g.. an internal ear-piece), to detect the obstacle and judge its distance.

(4) Appliances implanted in the body, used to support or replace the chemical fimction of certain organs (e.g.. secretion of insulin).

PARTS AND ACCESSORIES

Subject to the provisions of Notes I and 2 to this Chapter (see the General Explanatory Note), parts and accessories of appaiwitts or appliances of this heading remain classified here.

4.3.3.On perusal of the entries in the table supra, it is evident that tariff heading 9021 covers

“Orthopaedic appliances, including crutches, surgical belts and trusses; splints and other fracture appliances; artificial teeth and dental fittings, artificial parts of the body; hearing aids; and other appliances which are worn, carried, or implanted in the body to compensate ,for a defect or disability”. Within this tad heading, CT19021 10 00 constitutes a sub-category under “Orthopaedic or fracture appliances”. Similarly, I note that CT1 9021 39 00 constitutes a residual sub-category under “Other artificial parts of the body” which includes implantable devices not specifically enumerated elsewhere in the heading. Thus, 1 observe that in the instant case, the competing entries arc CTIs 9021 10 00 & 9021 39 00 and their applicability depends on whether the impugned goods can be regarded as “Orthopaedic or fracture appliances” or “artificial body parts” intended to compensate for a defect or disability as contemplated under Heading 9021.

4.3.4. I note that the Explanatory Notes to Heading 9021 clarifies that the scope of the heading is restricted to appliances which wholly or partially replace defective parts of the body or compensate for a defect or disability. In particular, the Notes specify that “Orthopaedic appliances” are those appliances which prevent or correct Bodily Deformity and support or hold parts of the body following operation or injury. On the other hand, 1 also note that “artificial parts of the body” include items such as artificial limbs, joints, ocular fittings, dental fittings and similar devices that replicate or substitute natural anatomical structures, usually resembling them in form or function. They further elaborate that this heading also covers certain implantable appliances designed to compensate for physiological deficiencies, such as pacemakers, speech aids for persons without vocal cords, and electronic aids for the blind.

4.3.5. On examination of the product under consideration viz. “Pyramesh Implant Mesh”, I observe that the product under consideration prevents spinal deformity and could be characterized as supporting/holding vertebrae following operation. It requires supplemental pedicle screw-rod fixation, suggesting it functions as a component within an orthopaedic fixation system where the screws/rods provide stabilization. However, the fundamental functional pattern of 9021 10 00 items is that they work with existing anatomical structures. In Paramesh’s application, the middle vertebral body is completely removed. Pyramesh does not hold fragments together since no fragments exist after complete excision, but rather fills the structural void where the entire vertebral body was and becomes that vertebral body througliosscointegration. The device does not “support or hold parts of the body” because the vertebral body it would support is entirely absent; instead, it replaces that absent body part.

4.3.6. I further observe that “Pyramesh Implant Mesh” replaces the absent vertebral body structure by filling the void; and it functions as the vertebral body after osseointegration creates a titanium-bone composite structure. This permanently replaces the absent vertebral body structure and is permanently implanted there to participate in the bone healing and fusion process, thereby becoming a part of body i.e. absent vertebrae. In view of the above, I observe that the item i.e. “Pyramesh Implant Mesh” is not holding together two parts of the bones but is replacing an absent body part which was in existence however removed because of trauma.

4.3.7. I further note that WCO explanatory Notes provide examples of artificial parts of body i.e. arms, forearms, hands legs, feet, nose which are very major in nature; they still include artificial joints such as hips, knees which replace existing body parts. This is analogues to the item “Pyramesh Implant Mesh” which replaces the absent vertebrae. Accordingly, to my opinion, the device functions by replacing the part concerned rather than by merely supporting or holding it, satisfies the definitional criterion for “artificial parts”. Accordingly, I reject the applicant’s claim for classification under 9021 1000, on the basis that Pyramesh Implant Mesh’ does not “support or hold parts of the body” because the vertebral body it would support is entirely absent; instead, it replaces that absent body part and conclude that the function of goods under consideration is satisfying the definitional criterion for “artificial parts” and is thus correctly classifiable under the CTH 9021 39 00.

4.3.8. Thus, I find that the product satisfies the legal scope of CTI 9021 39 00 as it is implanted in the body and replaces the anatomy permanently, therefore the same is not covered by preceding single-dash entries i.e. CT1 9021 10 00 but instead is covered by CTI 9021 39 00.

4.3.9. I have considered the U.S. CBP Ruling i.e. NY 804596 cited by the applicant in their support. The ruling, however, emanate from a foreign customs administration and are rendered within a distinct statutory framework. Although the Harmonized System is aligned globally at the six-digit level, the Indian tariff at the eight-digit CTI level, along with the accompanying legal notes and interpretative principles, diverges in material respects. Moreover, I find that the cited ruling does not pertain to device under consideration. Accordingly, while the foreign rulings have been duly noted, they do not hold persuasive value for classifying the “Pyramesh Implant Mesh” as “Orthopaedic or fracture appliances” under Indian CTI 9021 10 00.

5. In view of the foregoing analysis, I am of the considered view that the goods viz. “Pyramesh Implant Mesh”, proposed to be imported by the Applicant, merits classification under Tariff Heading 9021 and specifically under CTI 9021 39 00.

6. I, rule accordingly.