21 CFR 888.3500 — Prosthesis, Knee, Femorotibial, Semi-Constrained, Cemented, Metal/Composite

Orthopedic (OR) · Part 888 Subpart D—Prosthetic Devices · § 888.3500

Identification

A knee joint femorotibial metal/composite semi-constrained cemented prosthesis is a two-part device intended to be implanted to replace part of a knee joint. The device limits translation and rotation in one or more planes via the geometry of its articulating surfaces. It has no linkage across-the-joint. This generic type of device includes prostheses that have a femoral component made of alloys, such as cobalt-chromium-molybdenum, and a tibial component with the articulating surfaces made of ultra-high molecular weight polyethylene with carbon-fibers composite and is limited to those prostheses intended for use with bone cement (§ 888.3027).

Classification Rationale

Class II.

Product Codes