21 CFR 888.3590 — Prosthesis, Knee, Hemi-, Tibial, Resurfacing (Uncemented)

Orthopedic (OR) · Part 888 Subpart D—Prosthetic Devices · § 888.3590

Identification

A knee joint tibial (hemi-knee) metallic resurfacing uncemented prosthesis is a device intended to be implanted to replace part of a knee joint. The device limits minimally (less than normal anatomic constraints) translation in one or more planes. It has no linkage across-the-joint. This prosthesis is made of alloys, such as cobalt-chromium-molybdenum, and is intended to resurface one tibial condyle. The generic type of device is limited to those prostheses intended for use without bone cement (§ 888.3027).

Classification Rationale

Class II.

Product Codes