OCG · Prosthesis, Hip, Pelvifemoral Resurfacing, Metal/Polymer, Uncemented
Orthopedic · 21 CFR 888.3410 · Class 3
Overview
| Product Code | OCG |
|---|---|
| Device Name | Prosthesis, Hip, Pelvifemoral Resurfacing, Metal/Polymer, Uncemented |
| Regulation | 21 CFR 888.3410 |
| Device Class | Class 3 |
| Review Panel | Orthopedic |
| Implant | Yes |
Identification
A hip joint metal/polymer or ceramic/polymer semi-constrained resurfacing cemented prosthesis is a two-part device intended to be implanted to replace the articulating surfaces of the hip while preserving the femoral head and neck. 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 cap component made of a metal alloy, such as cobalt-chromium-molybdenum, or a ceramic material, that is placed over a surgically prepared femoral head, and an acetabular resurfacing polymer component. Both components are intended for use with bone cement (§ 888.3027).
Classification Rationale
Class III.
Cleared Devices (0)
No cleared devices on record.
