Approval for a change in packaging of the trident alumina inserts which are part of the trident ceramic system. The foam raw material used to manufacture the foam packaging components will change from opflex microcell l1900/mc1900 to vizion 2. 0, and the foam packaging component tolerances listed on the foam packaging component drawings will be updated to +/- 0. 120 inches to align the drawings with the manufacturing process currently used by the foam packaging component supplier.
| Device | Trident Ceramic System |
| Generic Name | Prosthesis, Hip, Semi-constrained, Metal/ceramic/ceramic/metal, Cemented Or Uncemented |
| Applicant | HOWMEDICA OSTEONICS CORP. |
| Date Received | 2021-01-05 |
| Decision Date | 2021-03-05 |
| PMA | P000013 |
| Supplement | S018 |
| 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