21 CFR 888.3320 — Prosthesis, Hip, Semi-Constrained (Metal Cemented Acetabular Component)

Orthopedic (OR) · Part 888 Subpart D—Prosthetic Devices · § 888.3320

Identification

A hip joint metal/metal semi-constrained, with a cemented acetabular component, 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 and an acetabular component, both made of alloys, such as cobalt-chromium-molybdenum. This generic type of device is limited to those prostheses intended for use with bone cement (§ 888.3027).

Classification Rationale

Class III.

Product Codes