---
kind: "section"
citation: "21 C.F.R. § 888.3550"
title: "21"
number: "888.3550"
heading: "Knee joint patellofemorotibial polymer/metal/metal constrained cemented prosthesis."
url: "https://uscodex.org/cfr/21/888.3550"
---

# §888.3550. Knee joint patellofemorotibial polymer/metal/metal constrained cemented prosthesis.

- (a) **Identification.** A knee joint patellofemorotibial polymer/metal/metal constrained cemented prosthesis is a device intended to be implanted to replace a knee joint. The device prevents dislocation in more than one anatomic plane and has components that are linked together. This generic type of device includes prostheses that have a femoral component, a tibial component, a cylindrical bolt and accompanying locking hardware that are all made of alloys, such as cobalt-chromium-molybdenum, and a retropatellar resurfacing component made of ultra-high molecular weight polyethylene. The retropatellar surfacing component may be attached to the resected patella either with a metallic screw or bone cement. All stemmed metallic components within this generic type are intended for use with bone cement ([§ 888.3027](/cfr/21/888.3027.md)).
- (b) **Classification.** Class III.
- (c) **Date PMA or notice of completion of a PDP is required.** A PMA or a notice of completion of a PDP is required to be filed with the Food and Drug Administration on or before December 26, 1996 for any knee joint patellofemorotibial polymer/metal/metal constrained cemented prosthesis that was in commercial distribution before May 28, 1976, or that has, on or before December 26, 1996 been found to be substantially equivalent to a knee joint patellofemorotibial polymer/metal/metal constrained cemented prosthesis that was in commercial distribution before May 28, 1976. Any other knee joint patellofemorotibial polymer/metal/metal constrained cemented prosthesis shall have an approved PMA or a declared completed PDP in effect before being placed in commercial distribution.

## Notes

### Amendments

[52 FR 33702, Sept. 4, 1987, as amended at 61 FR 50710, Sept. 27, 1996]

### 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

[52 FR 33702, Sept. 4, 1987, as amended at 61 FR 50710, Sept. 27, 1996]