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 pinnacle complete acetabular hip system. This device is indicated for:the pinnacle complete acetabular hip system is a single use device intended for uncemented fixation. The pinnacle complete acetabular hip system 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 jointdisease (nidjd) and its composite diagnoses of osteoarthritis (oa) or post-traumaticarthritis. Pinnacle complete acetabular hip system's inserts (pinnacle ultamet) are only intended for use with depuy's femoral and acetabular components having matching outer and inner diameters.
| Device | PINNACLE COMPLETE ACETABULAR HIP SYSTEM |
| Generic Name | Prosthesis, Hip, Semi-constrained, Ceramic-on-metal Articulation |
| Applicant | DEPUY ORTHOPAEDICS, INC. |
| Date Received | 2009-02-17 |
| Decision Date | 2011-06-13 |
| Notice Date | 2011-06-15 |
| PMA | P090002 |
| Supplement | S |
| Product Code | OVO |
| Docket Number | 11M-0470 |
| Advisory Committee | Orthopedic |
| Expedited Review | No |
| Combination Product | No |
| Applicant Address | DEPUY ORTHOPAEDICS, INC. p.o Box 988 700 Orthopaedic Drive warsaw, IN 46581-0988 |
| 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 |
|---|---|---|
| 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 |