KWR · Prosthesis, Shoulder, Constrained, Metal/Metal Or Metal/Polymer Cemented
Orthopedic · 21 CFR 888.3640 · Class 3
Overview
| Product Code | KWR |
|---|---|
| Device Name | Prosthesis, Shoulder, Constrained, Metal/Metal Or Metal/Polymer Cemented |
| Regulation | 21 CFR 888.3640 |
| Device Class | Class 3 |
| Review Panel | Orthopedic |
| Implant | Yes |
Identification
A shoulder joint metal/metal or metal/polymer constrained cemented prosthesis is a device intended to be implanted to replace a shoulder 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 humeral component made of alloys, such as cobalt-chromium-molybdenum, and a glenoid component made of this alloy or a combination of this alloy and ultra-high molecular weight polyethylene. This generic type of device is limited to those prostheses intended for use with bone cement (§ 888.3027).
Classification Rationale
Class III.
Recent Cleared Devices (0 of 0)
No cleared devices on record.
