21 CFR 888.3340 — Prosthesis, Hip, Semi-Constrained, Composite/Metal

Orthopedic (OR) · Part 888 Subpart D—Prosthetic Devices · § 888.3340

Identification

A hip joint metal/composite semi-constrained cemented prosthesis is a two-part device intended to be implanted to replace a hip 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 femoral component made of alloys, such as cobalt-chromium-molybdenum, and an acetabular component made of ultra-high molecular weight polyethylene with carbon fibers composite. Both components are intended for use with bone cement (§ 888.3027).

Classification Rationale

Class II.

Product Codes