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 | Trident Acetabular System: Trident Alumina Inserts |
| Generic Name | Prosthesis, Hip, Semi-constrained, Metal/ceramic/ceramic/metal, Cemented Or Uncemented |
| Applicant | HOWMEDICA OSTEONICS CORP.325 Corporate Drivemahwah, NJ 07430 PMA NumberP000013 Supplement NumberS020 Date Received03/03/2022 Decision Date04/01/2022 Product Code MRA Advisory Committee Orthopedic Supplement Typespecial (immediate Track) Supplement Reason Labeling Change - Indications/instructions/shelf Life/tradename Expedited Review Granted? No |
| Date Received | 2022-03-03 |
| Decision Date | 2022-04-01 |
| PMA | P000013 |
| Supplement | S020 |
| Product Code | MRA |
| Advisory Committee | Orthopedic |
| Supplement Type | Special (immediate Track) |
| Supplement Reason | Labeling Change - Indications/instructions/shelf Life/tradename |
| Expedited Review | No |
| Combination Product | No |
| Applicant Address | HOWMEDICA OSTEONICS CORP. 325 Corporate Drive mahwah, NJ 07430 PMA NumberP000013 Supplement NumberS020 Date Received03/03/2022 Decision Date04/01/2022 Product Code MRA Advisory Committee Orthopedic Supplement Typespecial (immediate Track) Supplement Reason Labeling Change - Indications/instructions/shelf Life/tradename Expedited Review Granted? No Combination ProductNo Approval Order Statement updating The Instructions For Use (IFU) For The Trident Acetabular System: Trident Alumina Inserts Because Of European Union (EU) Requirements. |
| Supplement Number | Date | Supplement Type |
|---|---|---|
| P000013 | Original Filing | |
| S020 | 2022-03-03 | Special (immediate Track) |
| S019 | 2022-02-03 | 30-day Notice |
| S018 | 2021-01-05 | Real-time Process |
| S017 | 2020-07-06 | Real-time Process |
| S016 | 2018-11-26 | 30-day Notice |
| S015 | 2018-09-20 | 30-day Notice |
| S014 | ||
| S013 | 2016-02-04 | 30-day Notice |
| S012 | 2015-10-01 | 30-day Notice |
| S011 | 2011-11-10 | Normal 180 Day Track No User Fee |
| S010 | 2011-10-03 | Real-time Process |
| S009 | 2009-04-16 | Special (immediate Track) |
| S008 | 2006-12-29 | Real-time Process |
| S007 | ||
| S006 | 2006-02-22 | 30-day Notice |
| S005 | 2004-09-09 | Real-time Process |
| S004 | 2004-04-15 | Real-time Process |
| S003 | 2003-08-13 | Normal 180 Day Track No User Fee |
| S002 | 2003-06-12 | Real-time Process |
| S001 | 2003-02-04 | Real-time Process |
| Device ID | PMA | Supp |
|---|---|---|
| 04546540516879 | P000013 | 001 |
| 04546540516862 | P000013 | 001 |
| 04546540516855 | P000013 | 001 |
| 04546540516848 | P000013 | 001 |
| 04546540516831 | P000013 | 001 |
| 04546540259936 | P000013 | 001 |