US LAWS, STATUTES & CODES ON-LINE

21 C.F.R. § 888.3560   Knee joint patellofemorotibial polymer/metal/polymer semi-constrained cemented prosthesis.

Title 21: Food and Drugs
PART 888—ORTHOPEDIC DEVICES
Subpart D—Prosthetic Devices

Browse Previous |  Browse Next

§ 888.3560   Knee joint patellofemorotibial polymer/metal/polymer semi-constrained cemented prosthesis.

(a) Identification. A knee joint patellofemorotibial polymer/metal/polymer semi-constrained cemented prosthesis is a device intended to be implanted to replace 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 have a femoral component made of alloys, such as cobalt-chromium-molybdenum, and a tibial component or components and a retropatellar resurfacing component made of ultra-high molecular weight polyethylene. This generic type of device is limited to those prostheses intended for use with bone cement (§888.3027).

(b) Classification. Class II.