KMC · Prosthesis, Hip, Semi-Constrained, Composite/Metal
Orthopedic · 21 CFR 888.3340 · Class 2
Overview
| Product Code | KMC |
|---|---|
| Device Name | Prosthesis, Hip, Semi-Constrained, Composite/Metal |
| Regulation | 21 CFR 888.3340 |
| Device Class | Class 2 |
| Review Panel | Orthopedic |
| Implant | Yes |
Identification
A hip joint metal/composite semi-constrained cemented prosthesis is a two-part 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 consist of a femoral component made of alloys, such as cobalt-chromium-molybdenum, and an acetabular component made of ultra-high molecular weight polyethylene with carbon fibers composite. Both components are intended for use with bone cement (§ 888.3027).
Classification Rationale
Class II.
Cleared Devices (3)
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K936044 | ENHANCED MODULAR AUSTIN MOORE HIP | Zimmer, Inc. | Apr 26, 1994 | SESE |
| K853524 | APR REVISION HIP PROSTHESIS, FEMORAL COMPONENT | Intermedics Orthopedics | Nov 22, 1985 | SN |
| K853259 | MALLORY/HEAD TOTAL HIP SYSTEM | Biomet, Inc. | Nov 1, 1985 | SN |
Top Applicants
- Zimmer, Inc. — 1 clearance
- Intermedics Orthopedics — 1 clearance
- Biomet, Inc. — 1 clearance
