21 CFR 888.3110 — Prosthesis, Ankle, Semi-Constrained, Cemented, Metal/Polymer

Orthopedic (OR) · Part 888 Subpart D—Prosthetic Devices · § 888.3110

Identification

An ankle joint metal/polymer 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 and has no linkage across-the-joint. This generic type of device includes prostheses that have a talar resurfacing component made of alloys, such as cobalt-chromium-molybdenum, and a tibial resurfacing 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 II.

Product Codes