---
kind: "section"
citation: "21 C.F.R. § 888.3565"
title: "21"
number: "888.3565"
heading: "Knee joint patellofemorotibial metal/polymer porous-coated uncemented prosthesis."
url: "https://uscodex.org/cfr/21/888.3565"
---

# §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](/cfr/21/888.1.md) for the availability of this guidance.

## Notes

### Amendments

[68 FR 14137, Mar. 24, 2003]

### Authority

Authority: 21 U.S.C. 351, 360, 360c, 360e, 360j, 360 l , 371.

### Source

Source: 52 FR 33702, Sept. 4, 1987, unless otherwise noted.

### Amendments

[68 FR 14137, Mar. 24, 2003]