Artificial Joints, Parts & Accessories

Heading 902131 is limited to devices that replicate the articulating function of a natural joint — such as total hip, knee, shoulder, or elbow replacements. Implants that replace a body part without providing joint articulation (e.g., bone void fillers, spinal interbody cages, or vascular grafts) are generally classified under 902139 or other headings. The device's functional design and FDA device classification can help confirm the correct heading.

Total joint replacements are generally Class III medical devices requiring FDA Premarket Approval (PMA) — the most rigorous FDA review pathway. The foreign manufacturer must hold an active PMA, be registered with FDA, and list the device. Importers should obtain copies of the PMA approval letter and confirm the establishment registration number before shipment, as FDA may detain or refuse entry for devices lacking valid approval. A licensed customs broker or regulatory affairs specialist should be consulted.