21 CFR 888.3410 — Prosthesis, Hip, Pelvifemoral Resurfacing, Metal/Polymer

Orthopedic (OR) · Part 888 Subpart D—Prosthetic Devices · § 888.3410

Identification

A hip joint metal/polymer or ceramic/polymer semi-constrained resurfacing cemented prosthesis is a two-part device intended to be implanted to replace the articulating surfaces of the hip while preserving the femoral head and neck. 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 cap component made of a metal alloy, such as cobalt-chromium-molybdenum, or a ceramic material, that is placed over a surgically prepared femoral head, and an acetabular resurfacing polymer component. Both components are intended for use with bone cement (§ 888.3027).

Classification Rationale

Class III.

Product Codes