PERFECTA TOTAL HIP SYSTEM, HEMI-HEAD COMPONENT
Device Facts
| Record ID | K915868 |
|---|---|
| Device Name | PERFECTA TOTAL HIP SYSTEM, HEMI-HEAD COMPONENT |
| Applicant | Orthomet, Inc. |
| Product Code | KWL · Orthopedic |
| Decision Date | Mar 23, 1992 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 888.3360 |
| Device Class | Class 2 |
Regulatory Classification
Identification
A hip joint femoral (hemi-hip) metallic cemented or uncemented prosthesis is a device intended to be implanted to replace a portion of the hip joint. This generic type of device includes prostheses that have a femoral component made of alloys, such as cobalt-chromium-molybdenum. This generic type of device includes designs which are intended to be fixed to the bone with bone cement (§ 888.3027) as well as designs which have large window-like holes in the stem of the device and which are intended for use without bone cement. However, in these latter designs, fixation of the device is not achieved by means of bone ingrowth.
