Onyx vascular occlusion device classification as anatomical replacement versus implanted appliance; found not anatomical replacement, classifiable under 9021 90 90

Whether the device is classifiable as an artificial part of the body under CTI 9021 31/39 or as another implanted appliance under CTI 9021 90 90: applying GRI I and the Explanatory Notes to Heading 9021, the AAR held that classification turns on anatomical replacement/essential character. The Onyx system's function is therapeutic intravascular occlusion, not substitution or restoration of anatomical structure; it occupies a vascular defect to induce thrombosis rather than replace a vessel segment. Consequently the device fails the anatomical-replacement test for 9021 31/39 and is classifiable under Tariff Heading 9021, specifically CTI 9021 90 90.

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Issues: Whether the product "Onyx Embolization System" is classifiable under subheading 9021 39 00 (other artificial parts of the body) or under subheading 9021 90 90 (other appliances implanted in the body to compensate for a defect or disability).

Analysis: The applicable legal framework comprises the General Rules of Interpretation (GRI) including Rule 1, Rule 6, Rule 3(a) and, where applicable, Rule 4, together with the Explanatory Notes to Heading 9021 of the First Schedule to the Customs Tariff Act, 1975 and the provisions of Section 28H(1) of the Customs Act, 1962 and CAAR Regulations, 2021. Heading 9021 covers artificial parts of the body and other appliances implanted or worn to compensate for defects. The Explanatory Notes identify "artificial parts of the body" as items that wholly or partially replace defective body parts and usually resemble them in appearance (examples: artificial limbs, tubes replacing blood vessels, heart valves). Applying GRI 1 and then GRI 6, the subheadings must be interpreted by their terms. The decisive factual-legal criterion is whether the good replaces/substitutes anatomical structure (qualifying for 9021.39) or instead is an implanted appliance that compensates without replacing anatomy (falling under the residual 9021.90). On the facts, the Onyx system is injected into existing abnormal vessels to create a controlled occlusion by forming a polymer cast; it does not replace, restore, or substitute an absent anatomical segment nor does it resemble a body part in the sense required by the Explanatory Notes. The device's therapeutic mechanism is permanent occlusion of an existing vessel rather than anatomical substitution. Foreign CBP rulings cited are noted but do not override the tariff language and Explanatory Notes as applied to the Indian CTI structure.

Conclusion: The product is classifiable under CTI 9021 90 90. This conclusion is against the applicant and in favour of the Revenue.

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