GroundRules
21 CFR 888.3390: Hip joint femoral (hemi-hip) metal/polymer cemented or uncemented prosthesis.
Where this section sits in the code
- Title 21—Food and Drugs
- CHAPTER I—FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES
- SUBCHAPTER H—MEDICAL DEVICES
- PART 888—ORTHOPEDIC DEVICES
- Subpart D—Prosthetic Devices
(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.
Collected 2026-08-27T02:24:47Z. Source file · JSON