FMP METAL/METAL ACETABULAR INSERT
Device Facts
| Record ID | K003250 |
|---|---|
| Device Name | FMP METAL/METAL ACETABULAR INSERT |
| Applicant | Encore Orthopedics, Inc. |
| Product Code | KWA · Orthopedic |
| Decision Date | Jan 25, 2001 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 888.3330 |
| Device Class | Class 3 |
Regulatory Classification
Identification
A hip joint metal/metal semi-constrained, with an uncemented acetabular component, 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 and an acetabular component, both made of alloys, such as cobalt-chromium-molybdenum. The femoral component is intended to be fixed with bone cement. The acetabular component is intended for use without bone cement (§ 888.3027).
