CFR > Title 21 - Food and Drugs > CHAPTER I—FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES > SUBCHAPTER H—MEDICAL DEVICES (parts 800 to 898) > PART 888—ORTHOPEDIC DEVICES > SUBPART D—Prosthetic Devices (§888.3000 to §888.3810) > 888.3400—Hip joint femoral (hemi-hip) metallic resurfacing prosthesis.

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

(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.