P.F.C.(R) BIPOLAR HIP SYSTEM - 22MM BIPOLAR
Device Facts
| Record ID | K945793 |
|---|---|
| Device Name | P.F.C.(R) BIPOLAR HIP SYSTEM - 22MM BIPOLAR |
| Applicant | Johnson & Johnson Professionals, Inc. |
| Product Code | KWY · Orthopedic |
| Decision Date | Apr 10, 1995 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 888.3390 |
| Device Class | Class 2 |
Regulatory Classification
Identification
A hip joint femoral (hemi-hip) metal/polymer cemented or uncemented prosthesis is a two-part device intended to be implanted to replace the head and neck of the femur. This generic type of device includes prostheses that have a femoral component made of alloys, such as cobalt-chromium-molybdenum, and a snap-fit acetabular component made of an alloy, such as cobalt-chromium-molybdenum, and ultra-high molecular weight polyethylene. This generic type of device may be fixed to the bone with bone cement (§ 888.3027) or implanted by impaction.
