21 C.F.R. § 888.3390

Current through May 31, 2024
Section 888.3390 - Hip joint femoral (hemi-hip) metal/polymer cemented or uncemented prosthesis
(a)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.
(b)Classification. Class II.

21 C.F.R. §888.3390