21 C.F.R. § 888.3350

Hip joint metal/polymer semi-constrained cemented prosthesis.

Last amended: 2016Year: 2026Length: 91 wordsSubsections: 2Official source

Cite as 21 C.F.R. § 888.3350 (2026)

(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.
Cross-references to the CFR
888.3027
21 C.F.R. § 888.3350: Hip joint metal/polymer semi-constrained cemented prosthesis. | Justis AI