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.
| Device | Scandinavian Total Ankle Replacement (STAR Ankle) |
| Generic Name | Prosthesis, Ankle, Uncemented, Non-constrained |
| Applicant | DJO Global9800 Metric Boulevardaustin, TX 78758 PMA NumberP050050 Supplement NumberS025 Date Received09/02/2022 Decision Date09/29/2022 Product Code NTG Advisory Committee Orthopedic Supplement Type30-day Notice Supplement Reason Process Change - Manufacturer/sterilizer/packager/supplier Expedited Review Granted? No |
| Date Received | 2022-09-02 |
| Decision Date | 2022-09-29 |
| PMA | P050050 |
| Supplement | S025 |
| Product Code | NTG |
| Advisory Committee | Orthopedic |
| Supplement Type | 30-day Notice |
| Supplement Reason | Process Change - Manufacturer/sterilizer/packager/supplier |
| Expedited Review | No |
| Combination Product | No |
| Applicant Address | DJO Global 9800 Metric Boulevard austin, TX 78758 PMA NumberP050050 Supplement NumberS025 Date Received09/02/2022 Decision Date09/29/2022 Product Code NTG Advisory Committee Orthopedic Supplement Type30-day Notice Supplement Reason Process Change - Manufacturer/sterilizer/packager/supplier Expedited Review Granted? No Combination ProductNo Approval Order Statement approval For Replacing A Milling Machine With Three Newer Machines. The Milling Machine Is Used In The Manufacturing Of The STAR Ankle Polyethylene Bearing Components |
| Supplement Number | Date | Supplement Type |
|---|---|---|
| P050050 | Original Filing | |
| S025 | 2022-09-02 | 30-day Notice |
| S024 | ||
| S023 | ||
| S022 | 2022-02-01 | 30-day Notice |
| S021 | ||
| S020 | 2021-11-19 | Special (immediate Track) |
| S019 | 2021-07-09 | Normal 180 Day Track No User Fee |
| S018 | 2021-03-24 | 30-day Notice |
| S017 | 2021-02-16 | 30-day Notice |
| S016 | 2020-12-14 | 30-day Notice |
| S015 | 2020-11-02 | 30-day Notice |
| S014 | 2020-08-03 | 30-day Notice |
| S013 | ||
| S012 | 2018-08-21 | Real-time Process |
| S011 | 2017-10-10 | Real-time Process |
| S010 | 2016-07-12 | Real-time Process |
| S009 | ||
| S008 | 2016-04-11 | Normal 180 Day Track No User Fee |
| S007 | 2014-03-11 | Normal 180 Day Track No User Fee |
| S006 | 2014-03-10 | Real-time Process |
| S005 | 2012-11-13 | Special (immediate Track) |
| S004 | 2012-09-04 | Normal 180 Day Track No User Fee |
| S003 | ||
| S002 | 2009-08-21 | Normal 180 Day Track No User Fee |
| S001 | 2009-08-05 | Normal 180 Day Track No User Fee |
| Device ID | PMA | Supp |
|---|---|---|
| 00850062461369 | P050050 | 000 |
| 00810028394971 | P050050 | 023 |
| 00810028393431 | P050050 | 023 |
| 00810028393448 | P050050 | 023 |
| 00810028393455 | P050050 | 023 |
| 00810028393462 | P050050 | 023 |
| 00810028393486 | P050050 | 024 |
| 00810028393493 | P050050 | 024 |
| 00810028393509 | P050050 | 024 |
| 00810028393516 | P050050 | 024 |
| 00810028393523 | P050050 | 024 |
| 00810028393530 | P050050 | 024 |
| 00810028393547 | P050050 | 024 |
| 00810028393554 | P050050 | 024 |
| 00810028393479 | P050050 | 024 |