Regulations last checked for updates: Feb 15, 2026

Title 21 - Food and Drugs last revised: Dec 18, 2026
§ 888.3400 - Hip joint femoral (hemi-hip) metallic resurfacing prosthesis.

(a) Identification. A hip joint femoral (hemi-hip) metallic resurfacing prosthesis is a device intended to be implanted to replace a portion of the hip joint. This generic type of device includes prostheses that have a femoral resurfacing component made of alloys, such as cobalt-chromium-molybdenum.

(b) Classification. Class II.

authority: 21 U.S.C. 351,360,360c,360e,360j,360
source: 52 FR 33702, Sept. 4, 1987, unless otherwise noted.
cite as: 21 CFR 888.3400