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 avanta braun-cutter trapezo-metacarpal prosthesis. This device is indicated for total joint replacement in skeletally mature patients with pain or instability of the trapezo-metacarpal joint due to trauma, inflammatory or degenerative disease or revision of previous procedures, as an alternative to arthrodesis or reconstructive surgery.
| Device | BRAUN-CUTTER TRAPEZO-METACARPAL PROSTHESIS |
| Generic Name | Prosthesis, Finger, Constrained, Metal/polymer |
| Applicant | STRYKER CORPORATION |
| Date Received | 1996-12-24 |
| Decision Date | 1997-06-19 |
| Notice Date | 1997-09-23 |
| PMA | P960053 |
| Supplement | S |
| Product Code | KWG |
| Docket Number | 97M-0393 |
| Advisory Committee | Orthopedic |
| Expedited Review | No |
| Combination Product | No |
| Applicant Address | STRYKER CORPORATION bohnackerweg 1 selzach CH 25 |
| Supplement Number | Date | Supplement Type |
|---|---|---|
| P960053 | Original Filing | |
| S005 | 2016-07-13 | Special (immediate Track) |
| S004 | 2007-08-24 | Normal 180 Day Track No User Fee |
| S003 | 2002-11-08 | Normal 180 Day Track |
| S002 | 1998-04-16 | Normal 180 Day Track |
| S001 | 1998-03-31 | Normal 180 Day Track |