KRN · Metal Cemented Constrained Femorotibial Knee Prosthesis
Orthopedic · 21 CFR 888.3480 · Class 3
Overview
| Product Code | KRN |
|---|---|
| Device Name | Metal Cemented Constrained Femorotibial Knee Prosthesis |
| Regulation | 21 CFR 888.3480 |
| Device Class | Class 3 |
| Review Panel | Orthopedic |
| Implant | Yes |
Identification
A knee joint femorotibial metallic constrained cemented prosthesis is a device intended to be implanted to replace part of a knee joint. The device prevents dislocation in more than one anatomic plane and has components that are linked together. The only knee joint movement allowed by the device is in the sagittal plane. This generic type of device includes prostheses that have an intramedullary stem at both the proximal and distal locations. The upper and lower components may be joined either by a solid bolt or pin, an internally threaded bolt with locking screw, or a bolt retained by circlip. The components of the device are made of alloys, such as cobalt-chromium-molybdenum. The stems of the device may be perforated, but are intended for use with bone cement (§ 888.3027).
Classification Rationale
Class III.
Cleared Devices (0)
No cleared devices on record.
