21 CFR 888.3480 — Prosthesis, Knee, Hinged (Metal-Metal)
Orthopedic (OR) · Part 888 Subpart D—Prosthetic Devices · § 888.3480
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.
Product Codes
| Product Code | Device Name | Class | Devices | Attributes |
|---|---|---|---|---|
| HRZ | Prosthesis, Knee, Hinged (Metal-Metal) | 3 | 0 | Implant |
| KRN | Metal Cemented Constrained Femorotibial Knee Prosthesis | 3 | 0 | Implant |
