21 CFR 888.3380 — Prosthesis, Hip, Hemi-, Trunnion-Bearing, Femoral, Metal/Polyacetal

Orthopedic (OR) · Part 888 Subpart D—Prosthetic Devices · § 888.3380

Identification

A hip joint femoral (hemi-hip) trunnion-bearing metal/polyacetal cemented prosthesis is a two-part device intended to be implanted to replace the head and neck of the femur. This generic type of device includes prostheses that consist of a metallic stem made of alloys, such as cobalt-chromium-molybdenum, with an integrated cylindrical trunnion bearing at the upper end of the stem that fits into a recess in the head of the device. The head of the device is made of polyacetal (polyoxymethylene) and it is covered by a metallic alloy, such as cobalt-chromium-molybdenum. The trunnion bearing allows the head of the device to rotate on its stem. The prosthesis is intended for use with bone cement (§ 888.3027).

Classification Rationale

Class III.

Product Codes