Approval for the addition of the tritanium psf acetabular shells (solid-backed and cluster screw-hole designs) as compatible components with the trident ceramic inserts, as well as modifications to the tolerances and surface roughness values of the taper region of all compatible trident and tritanium acetabular shells. In addition, labeling changes were made to address the compatibility with the new components.
| Device | 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 | 2011-10-03 |
| Decision Date | 2012-01-18 |
| PMA | P000013 |
| Supplement | S010 |
| Product Code | MRA |
| Advisory Committee | Orthopedic |
| Supplement Type | Real-time Process |
| Supplement Reason | Change Design/components/specifications/material |
| 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