MALLORY/HEAD TOTAL HIP SYSTEM
Device Facts
| Record ID | K853259 |
|---|---|
| Device Name | MALLORY/HEAD TOTAL HIP SYSTEM |
| Applicant | Biomet, Inc. |
| Product Code | KMC · Orthopedic |
| Decision Date | Nov 1, 1985 |
| Decision | SN |
| Submission Type | Traditional |
| Regulation | 21 CFR 888.3340 |
| Device Class | Class 2 |
Regulatory Classification
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).
