Title 21: Food and Drugs
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/ PART 888 - ORTHOPEDIC DEVICES
/ Subpart D - Prosthetic Devices / § 888.3530 Knee joint femorotibial metal/polymer semi-constrained cemented prosthesis.
§ 888.3530 Knee joint femorotibial metal/polymer semi-constrained cemented prosthesis.
(a) Identification. A knee joint femorotibial metal/polymer semi-constrained cemented prosthesis is a device intended to be implanted to replace part of a knee 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 component made of alloys, such as cobalt-chromium-molybdenum, and a tibial 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.