21 CFR 888.3640 — Prosthesis, Shoulder, Constrained, Metal/Metal Or Metal/Polymer Cemented

Orthopedic (OR) · Part 888 Subpart D—Prosthetic Devices · § 888.3640

Identification

A shoulder joint metal/metal or metal/polymer constrained cemented prosthesis is a device intended to be implanted to replace a shoulder joint. The device prevents dislocation in more than one anatomic plane and has components that are linked together. This generic type of device includes prostheses that have a humeral component made of alloys, such as cobalt-chromium-molybdenum, and a glenoid component made of this alloy or a combination of this alloy and ultra-high molecular weight polyethylene. This generic type of device is limited to those prostheses intended for use with bone cement (§ 888.3027).

Classification Rationale

Class III.

Product Codes