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.
Approval for the addition of the trilock bps (bone preserving hip stem) to the list of compatible femoral stem components. The device, as modified, will be marketed under the trade name depuy pinnacle complete acetabular hip system and is indicated as a single use device intended for uncemented fixation. The device is intended as a primary joint replacement prosthesis in total hip arthroplasty for skeletally mature patients suffering at least moderate pain in the hip joint from non-inflammatory degenerative joint disease (nidjd) and its composite diagnoses of osteoarthritis (oa) or post-traumatic arthritis. The device¿s inserts (pinnacle ultamet) are only intended for use with depuy¿s femoral and acetabular components having matching outer and inner diameters.
| Device | DEPUY PINNACLE COMPLETE ACETABULAR HIP SYSTEM |
| Generic Name | Prosthesis, Hip, Semi-constrained, Ceramic-on-metal Articulation |
| Applicant | DEPUY ORTHOPAEDICS, INC. |
| Date Received | 2012-01-19 |
| Decision Date | 2012-04-17 |
| PMA | P090002 |
| Supplement | S002 |
| Product Code | OVO |
| Advisory Committee | Orthopedic |
| Supplement Type | Real-time Process |
| Supplement Reason | Change Design/components/specifications/material |
| Expedited Review | No |
| Combination Product | No |
| Applicant Address | DEPUY ORTHOPAEDICS, INC. p.o Box 988 700 Orthopaedic Drive warsaw, IN 46581-0988 |
| Supplement Number | Date | Supplement Type |
|---|---|---|
| P090002 | Original Filing | |
| S009 | 2013-03-12 | 135 Review Track For 30-day Notice |
| S008 | ||
| S007 | 2012-11-28 | Special (immediate Track) |
| S006 | 2012-10-25 | 30-day Notice |
| S005 | 2012-08-03 | Special (immediate Track) |
| S004 | 2012-05-18 | 30-day Notice |
| S003 | 2012-03-27 | 30-day Notice |
| S002 | 2012-01-19 | Real-time Process |
| S001 | 2011-09-07 | Normal 180 Day Track No User Fee |