This medical device has supplements. The device description/function or indication may have changed. Be sure to look at the supplements to get an up-to-date information on device changes. The labeling included below is the version at time of approval of the original pma or panel track supplement and may not represent the most recent labeling.
Approval for the stelkast surpass acetabular system. The device is indicated for cementless use in primary total hip arthroplasty in skeletally mature individuals with non-inflammatory degenerative joint disease such as osteoarthritis, avascular necrosis, congenital hip dysplasia, and traumatic arthritis.
| Device | STELKAST SURPASS ACETABULAR SYSTEM |
| Generic Name | Prosthesis, Hip, Semi-constrained, Metal/ceramic/ceramic/metal, Cemented Or Uncemented |
| Applicant | STELKAST COMPANY |
| Date Received | 2004-12-27 |
| Decision Date | 2006-05-12 |
| Notice Date | 2007-03-26 |
| PMA | P040051 |
| Supplement | S |
| Product Code | MRA |
| Docket Number | 07M-0109 |
| Advisory Committee | Orthopedic |
| Expedited Review | No |
| Combination Product | No |
| Applicant Address | STELKAST COMPANY 200 Hidden Valley Road mcmurray, PA 15317 |
| Summary: | Summary of Safety and Effectiveness |
| Labeling: | Labeling |
| Post-Approval Study: | Show Report Schedule and Study Progress |
| Approval Order: | Approval Order |
| Supplement Number | Date | Supplement Type |
|---|---|---|
| P040051 | Original Filing | |
| S002 | 2009-10-06 | Normal 180 Day Track No User Fee |
| S001 | 2007-12-17 | 135 Review Track For 30-day Notice |