21 CFR 888.3100 — Prosthesis, Ankle, Semi-Constrained, Cemented, Metal/Composite

Orthopedic (OR) · Part 888 Subpart D—Prosthetic Devices · § 888.3100

Identification

An ankle joint metal/composite semi-constrained cemented prosthesis is a device intended to be implanted to replace an ankle 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 consist of a talar resurfacing component made of alloys, such as cobalt-chromium-molybdenum, and a tibial resurfacing component fabricated from 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