This medical device record is a pma supplement. A supplement may have changed the device description/function or indication from that approved in the original pma. Be sure to look at the original pma record for more information.
Approval for implementation of new software to the manufacturing line to allow polished inserts to be reworked, following inspection, in one of the two inner sphere polishing stations, while the other station continues to be used for initial production.
| Device | STELKAST SURPASS ACETABULAR SYSTEM |
| Generic Name | Prosthesis, Hip, Semi-constrained, Metal/ceramic/ceramic/metal, Cemented Or Uncemented |
| Applicant | STELKAST COMPANY |
| Date Received | 2007-12-17 |
| Decision Date | 2009-05-08 |
| PMA | P040051 |
| Supplement | S001 |
| Product Code | MRA |
| Advisory Committee | Orthopedic |
| Supplement Type | 135 Review Track For 30-day Notice |
| Supplement Reason | Process Change - Manufacturer/sterilizer/packager/supplier |
| Expedited Review | No |
| Combination Product | No |
| Applicant Address | STELKAST COMPANY 200 Hidden Valley Road mcmurray, PA 15317 |
| 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 |