Annuloplasty Bands/Ring classified as implantable therapeutic support, not an artificial body part, therefore under CTI 9021 90 90

Classification of Annexuloplasty Bands/Ring addressed whether the devices are artificial parts replacing anatomy or implantable appliances providing therapeutic support. Applying the specificity principle and the anatomical replacement test, the device was found to support and reinforce the native valve annulus without substituting its anatomy, so it fails the anatomical replacement criterion for artificial body parts. The decision rejects classification as an artificial body part and finds the product falls within the scope of the tariff provision for implantable appliances worn or carried or implanted to compensate for a defect, resulting in classification under CTI 9021 90 90. International rulings were found non-persuasive given national eight-digit divergence.

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Issues: Whether the product described as "Annuloplasty Band/Ring" is classifiable under CTI 9021 39 00 (other artificial parts of the body) or under CTI 9021 90 90 (other appliances which are worn or carried, or implanted in the body, to compensate for a defect or disability).

Analysis: The Authority examined the product description and its medical function, the terms of Heading 9021 and the competing subheadings, and the relevant Explanatory Notes and General Rules of Interpretation (GRI). The product is an implantable, biocompatible ring/band sutured to the heart annulus to provide structural support and to restore annular geometry, while the native valve and annulus remain in situ. The scope of subheading 9021.39 (other artificial parts of the body) in the Explanatory Notes contemplates items that wholly or partially replace defective anatomical parts and usually resemble them in appearance; examples include artificial limbs, heart valves and tubes for replacing blood vessels. Subheading 9021.90 is a residual entry covering other appliances implanted or worn to compensate for a defect or disability, including standalone assistive implants and parts/accessories of 9021 devices. The Authority found that the annuloplasty band does not replace or substitute the anatomical structure of the valve or annulus and does not satisfy the replacement/ resemblance characteristics central to 9021.39. Applying GRI 1 and GRI 6, and by elimination from preceding specific subheadings under Heading 9021, the product fits within the residual scope of 9021.90. Foreign CBP rulings cited by the applicant were noted but held not persuasive to override the tariff language and the classificatory criteria under the Indian schedule.

Conclusion: The Annuloplasty Band/Ring is classifiable under CTI 9021 90 90 and not under CTI 9021 39 00. The ruling is therefore against the applicant's proposed classification.

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