OQH · Hip, Semi-Constrained, Cemented, Metal/Polymer + Additive, Cemented
Orthopedic · 21 CFR 888.3350 · Class 2
Overview
| Product Code | OQH |
|---|---|
| Device Name | Hip, Semi-Constrained, Cemented, Metal/Polymer + Additive, Cemented |
| Regulation | 21 CFR 888.3350 |
| Device Class | Class 2 |
| Review Panel | Orthopedic |
| Implant | Yes |
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.
Recent Cleared Devices (0 of 0)
No cleared devices on record.
