21 CFR 888.3300 — Prosthesis, Hip, Constrained, Metal
Orthopedic (OR) · Part 888 Subpart D—Prosthetic Devices · § 888.3300
Identification
A hip joint metal constrained cemented or uncemented prosthesis is a device intended to be implanted to replace a hip 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 components made of alloys, such as cobalt-chromium-molybdenum, and is intended for use with or without bone cement (§ 888.3027). This device is not intended for biological fixation.
Classification Rationale
Class III.
Product Codes
| Product Code | Device Name | Class | Devices | Attributes |
|---|---|---|---|---|
| KXD | Prosthesis, Hip, Constrained, Metal | 3 | 0 | Implant |
