21 CFR 888.3570 — Prosthesis, Knee, Hemi-, Femoral
Orthopedic (OR) · Part 888 Subpart D—Prosthetic Devices · § 888.3570
Identification
A knee joint femoral (hemi-knee) metallic uncemented prosthesis is a device made of alloys, such as cobalt-chromium-molybdenum, intended to be implanted to replace part of a knee joint. The device limits translation and rotation in one or more planes via the geometry of its articulating surfaces. It has no linkage across-the-joint. This generic type of device includes prostheses that consist of a femoral component with or without protuberance(s) for the enhancement of fixation and is limited to those prostheses intended for use without bone cement (§ 888.3027).
Classification Rationale
Class III.
Product Codes
| Product Code | Device Name | Class | Devices | Attributes |
|---|---|---|---|---|
| HSA | Prosthesis, Knee, Hemi-, Femoral | 3 | 0 | Implant |
| KRS | Prosthesis, Knee, Hemi-, Femoral (Uncemented) | 3 | 0 | Implant |
