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) > 888.3320—Hip joint metal/metal semi-constrained, with a cemented acetabular component, prosthesis.

888.3320—Hip joint metal/metal semi-constrained, with a cemented acetabular component, prosthesis.

(a) Identification. A hip joint metal/metal semi-constrained, with a cemented acetabular component, prosthesis is a two-part device intended to be implanted to replace a hip joint. The device limits translation and rotation in one or more planes via the geometry of its articulating surfaces. It has no linkage across-the-joint. This generic type of device includes prostheses that consist of a femoral and an acetabular component, both made of alloys, such as cobalt-chromium-molybdenum. This generic type of device is limited to those prostheses intended for use with bone cement ( § 888.3027 ).
(b) Classification. Class III.
(c) Date PMA or notice of completion of a PDP is required. No effective date has been established of the requirement for premarket approval. See § 888.3.