21 CFR 888.3120 — Prosthesis, Ankle, Cemented, Non-Constrained

Orthopedic (OR) · Part 888 Subpart D—Prosthetic Devices · § 888.3120

Identification

An ankle joint metal/polymer non-constrained cemented prosthesis is a device intended to be implanted to replace an ankle 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 tibial component made of alloys, such as cobalt-chromium-molybdenum, and a talar component made of ultra-high molecular weight polyethylene, and is limited to those prostheses intended for use with bone cement (§ 888.3027).

Classification Rationale

Class III.

Product Codes