21 CFR 888.3520 — Prosthesis, Knee, Femorotibial, Non-Constrained, Cemented, Metal/Polymer

Orthopedic (OR) · Part 888 Subpart D—Prosthetic Devices · § 888.3520

Identification

A knee joint femorotibial metal/polymer non-constrained cemented 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 generic type of device includes prostheses that have a femoral condylar resurfacing component or components made of alloys, such as cobalt-chromium-molybdenum, and a tibial component or components made of ultra-high molecular weight polyethylene and are intended for use with bone cement (§ 888.3027).

Classification Rationale

Class II.

Product Codes