21 CFR § 888.3400
Hip joint femoral (hemi-hip) metallic resurfacing prosthesis
June 25, 2020
(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.