Title 21 Part 888 → Subpart D → §888.3565

Title 21 → Chapter I → Subchapter H → Part 888 → Subpart D → §888.3565

Electronic Code of Federal Regulations e-CFR

Title 21 Part 888 → Subpart D → §888.3565

e-CFR data is current as of May 26, 2020

Title 21Chapter ISubchapter HPart 888Subpart D → §888.3565

Title 21: Food and Drugs
Subpart D—Prosthetic Devices

§888.3565   Knee joint patellofemorotibial metal/polymer porous-coated uncemented prosthesis.

(a) Identification. A knee joint patellofemorotibial metal/polymer porous-coated uncemented 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 is designed to achieve biological fixation to bone without the use of bone cement. This identification includes fixed-bearing knee prostheses where the ultra high molecular weight polyethylene tibial bearing is rigidly secured to the metal tibial base plate.

(b) Classification. Class II (special controls). The special control is FDA's guidance: “Class II Special Controls Guidance Document: Knee Joint Patellofemorotibial and Femorotibial Metal/Polymer Porous-Coated Uncemented Prostheses; Guidance for Industry and FDA.” See §888.1 for the availability of this guidance.

[68 FR 14137, Mar. 24, 2003]