---
kind: "section"
citation: "21 C.F.R. § 888.3670"
title: "21"
number: "888.3670"
heading: "Shoulder joint metal/polymer/metal nonconstrained or semi-constrained porous-coated uncemented prosthesis."
url: "https://uscodex.org/cfr/21/888.3670"
---

# §888.3670. Shoulder joint metal/polymer/metal nonconstrained or semi-constrained porous-coated uncemented prosthesis.

- (a) **Identification.** A shoulder joint metal/polymer/metal nonconstrained or semi-constrained porous-coated uncemented prosthesis is a device intended to be implanted to replace a shoulder joint. The device limits movement in one or more planes. It has no linkage across-the-joint. This generic type of device includes prostheses that have a humeral component made of alloys such as cobalt-chromium-molybdenum (Co-Cr-Mo) and titanium-aluminum-vanadium (Ti-6Al-4V) alloys, and a glenoid resurfacing component made of ultra-high molecular weight polyethylene, or a combination of an articulating ultra-high molecular weight bearing surface fixed in a metal shell made of alloys such as Co-Cr-Mo and Ti-6Al-4V. The humeral component and glenoid backing have a porous coating made of, in the case of Co-Cr-Mo components, beads of the same alloy or commercially pure titanium powder, and in the case of Ti-6Al-4V components, beads or fibers of commercially pure titanium or Ti-6Al-4V alloy, or commercially pure titanium powder. The porous coating has a volume porosity between 30 and 70 percent, an average pore size between 100 and 1,000 microns, interconnecting porosity, and a porous coating thickness between 500 and 1,500 microns. This generic type of device is designed to achieve biological fixation to bone without the use of bone cement.
- (b) **Classification.** Class II (special controls). The special control for this device is FDA's “Class II Special Controls Guidance: Shoulder Joint Metal/Polymer/Metal Nonconstrained or Semi-Constrained Porous-Coated Uncemented Prosthesis.”

## Notes

### Amendments

[66 FR 12737, Feb. 28, 2001]

### 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

[66 FR 12737, Feb. 28, 2001]