Approval for revisions to the trident acetabular system package insert and patient labeling. These changes include editing text for conciseness and clarity, reorganizing elements to more clearly convey intent, and presenting data in a manner that is less confusing and more meaningful to patients and surgeons.
| Device | OSTEONICS ABC/TRIDENT SYSTEMS |
| Classification Name | Prosthesis, Hip, Semi-constrained, Metal/ceramic/ceramic/metal, Cemented Or Uncemented |
| Generic Name | Prosthesis, Hip, Semi-constrained, Metal/ceramic/ceramic/metal, Cemented Or Uncemented |
| Applicant | HOWMEDICA OSTEONICS CORP. |
| Date Received | 2003-06-12 |
| Decision Date | 2003-09-12 |
| PMA | P000013 |
| Supplement | S002 |
| Product Code | MRA |
| Advisory Committee | Orthopedic |
| Supplement Type | Real-time Process |
| 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 |
Supplemental Filings
| 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 |
NIH GUDID Devices