21 CFR 888.3220 — Prosthesis, Finger, Constrained, Metal/Polymer

Orthopedic (OR) · Part 888 Subpart D—Prosthetic Devices · § 888.3220

Identification

A finger joint metal/polymer constrained cemented prosthesis is a device intended to be implanted to replace a metacarpophalangeal or proximal interphalangeal (finger) joint. The device prevents dislocation in more than one anatomic plane, and consists of two components which are linked together. This generic type of device includes prostheses that are made of alloys, such as cobalt-chromium-molybdenum, and 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