21 CFR § 888.3400 Orthopedic Devices

§ 888.3400 Hip joint femoral (hemi-hip) metallic resurfacing prosthesis.

Current through Sep 8, 2026 · Read all of Part 888

(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.

← § 888.3390 Hip joint femoral (hemi-hip) metal/polymer cemented or uncemented prosthesis.§ 888.3410 Hip joint metal/polymer or ceramic/polymer semiconstrained resurfacing cemented prosthesis. →