21 C.F.R. § 888.3390 Hip joint femoral (hemi-hip) metal/polymer cemented or uncemented prosthesis.
Title 21 - Food and Drugs
(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.
Title 21: Food and Drugs
PART 888—ORTHOPEDIC DEVICES
Subpart D—Prosthetic Devices
§ 888.3390 Hip joint femoral (hemi-hip) metal/polymer cemented or uncemented prosthesis.
