Title 21 Part 888 → Subpart D → §888.3535

Title 21 → Chapter I → Subchapter H → Part 888 → Subpart D → §888.3535

Electronic Code of Federal Regulations e-CFR

Title 21 Part 888 → Subpart D → §888.3535

e-CFR data is current as of January 27, 2020

Title 21Chapter ISubchapter HPart 888Subpart D → §888.3535

Title 21: Food and Drugs
Subpart D—Prosthetic Devices

§888.3535   Knee joint femorotibial (uni-compartmental) metal/polymer porous-coated uncemented prosthesis.

(a) Identification. A knee joint femorotibial (uni-compartmental) metal/polymer porous-coated uncemented 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 surface. 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 baseplate.

(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]