21 CFR 888.3390 — Prosthesis, Hip, Hemi-, Femoral, Metal/Polymer, Cemented Or Uncemented

Orthopedic (OR) · Part 888 Subpart D—Prosthetic Devices · § 888.3390

Identification

A hip joint femoral (hemi-hip) metal/polymer cemented or uncemented 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 have a femoral component made of alloys, such as cobalt-chromium-molybdenum, and a snap-fit acetabular component made of an alloy, such as cobalt-chromium-molybdenum, and ultra-high molecular weight polyethylene. This generic type of device may be fixed to the bone with bone cement (§ 888.3027) or implanted by impaction.

Classification Rationale

Class II.

Product Codes