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.

CFR

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