OSTEONICS OMNIFIT AD-HA HIP STEM SERIES
Device Facts
| Record ID | K941366 |
|---|---|
| Device Name | OSTEONICS OMNIFIT AD-HA HIP STEM SERIES |
| Applicant | Osteonics Corp. |
| Product Code | MEH · Orthopedic |
| Decision Date | Jun 6, 1995 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 888.3353 |
| Device Class | Class 2 |
Regulatory Classification
Identification
A hip joint metal/ceramic/polymer semi-constrained cemented or nonporous uncemented prosthesis is a device intended to be implanted to replace a hip joint. This device limits translation and rotation in one or more planes via the geometry of its articulating surfaces. It has no linkage across-the-joint. The two-part femoral component consists of a femoral stem made of alloys to be fixed in the intramedullary canal of the femur by impaction with or without use of bone cement. The proximal end of the femoral stem is tapered with a surface that ensures positive locking with the spherical ceramic (aluminium oxide, A12 03 ) head of the femoral component. The acetabular component is made of ultra-high molecular weight polyethylene or ultra-high molecular weight polyethylene reinforced with nonporous metal alloys, and used with or without bone cement.
