This medical device has supplements. The device description/function or indication may have changed. Be sure to look at the supplements to get an up-to-date information on device changes. The labeling included below is the version at time of approval of the original pma or panel track supplement and may not represent the most recent labeling.
Approval for the trilogy ab acetabular system. The device is indicated for either cemented or noncemented use in skeletally mature individuals undergoing primary surgery for rehabilitating hips damaged as a result of noninflammatory degenerative joint disease (nidjd) such as osteoarthritis, avascular necrosis, congenital hip dysplasia, and traumatic arthritis.
| Device | TRILOGY AB ACETABULAR SYSTEM |
| Generic Name | Prosthesis, Hip, Semi-constrained, Metal/ceramic/ceramic/metal, Cemented Or Uncemented |
| Applicant | ZIMMER, INC. |
| Date Received | 2004-12-14 |
| Decision Date | 2006-06-28 |
| Notice Date | 2007-06-28 |
| PMA | P040048 |
| Supplement | S |
| Product Code | MRA |
| Docket Number | 07M-0259 |
| Advisory Committee | Orthopedic |
| Expedited Review | No |
| Combination Product | No |
| Applicant Address | ZIMMER, INC. p.o. Box 708 warsaw, IN 46581-0708 |
| Summary: | Summary of Safety and Effectiveness |
| Labeling: | Labeling |
| Post-Approval Study: | Show Report Schedule and Study Progress |
| Approval Order: | Approval Order |
| Supplement Number | Date | Supplement Type |
|---|---|---|
| P040048 | Original Filing | |
| S017 | 2012-04-06 | 135 Review Track For 30-day Notice |
| S016 | 2012-01-12 | 30-day Notice |
| S015 | 2011-06-14 | Normal 180 Day Track No User Fee |
| S014 | 2011-05-02 | Special (immediate Track) |
| S013 | ||
| S012 | 2009-11-24 | 30-day Notice |
| S011 | 2009-11-23 | 30-day Notice |
| S010 | 2009-11-09 | 30-day Notice |
| S009 | 2009-09-14 | Normal 180 Day Track No User Fee |
| S008 | 2009-05-11 | Normal 180 Day Track No User Fee |
| S007 | ||
| S006 | ||
| S005 | 2008-04-17 | 30-day Notice |
| S004 | 2008-04-16 | 135 Review Track For 30-day Notice |
| S003 | 2007-11-30 | 135 Review Track For 30-day Notice |
| S002 | 2007-01-26 | 135 Review Track For 30-day Notice |
| S001 | 2006-10-12 | Normal 180 Day Track No User Fee |