21 CFR 888.3350 — Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented
Orthopedic (OR) · Part 888 Subpart D—Prosthetic Devices · § 888.3350
Identification
A hip joint metal/polymer semi-constrained cemented prosthesis is a device intended to be implanted to replace a hip 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 have a femoral component made of alloys, such as cobalt-chromium-molybdenum, and an acetabular resurfacing component made of ultra-high molecular weight polyethylene and is limited to those prostheses intended for use with bone cement (§ 888.3027).
Classification Rationale
Class II.
Product Codes
| Product Code | Device Name | Class | Devices | Attributes |
|---|---|---|---|---|
| JDI | Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented | 2 | 562 | Implant |
| OQH | Hip, Semi-Constrained, Cemented, Metal/Polymer + Additive, Cemented | 2 | 0 | Implant |
| PLW | Acetabular Cup Orientation System | 2 | 1 |
