21 C.F.R. § 888.3350

Current through November 30, 2024
Section 888.3350 - Hip joint metal/polymer semi-constrained cemented prosthesis
(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.

21 C.F.R. §888.3350