21 CFR § 888.3350 Orthopedic Devices

§ 888.3350 Hip joint metal/polymer semi-constrained cemented prosthesis.

Current through Sep 8, 2026 · Read all of Part 888

(a) Identification. A hip joint metal/polymer semi-constrained cemented prosthesis is a 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 have a femoral component made of alloys, such as cobalt-chromium-molybdenum, and an acetabular resurfacing component made of ultra-high molecular weight polyethylene and is limited to those prostheses intended for use with bone cement (§ 888.3027).

(b) Classification. Class II.

← § 888.3340 Hip joint metal/composite semi-constrained cemented prosthesis.§ 888.3353 Hip joint metal/ceramic/polymer semi-constrained cemented or nonporous uncemented prosthesis. →