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 duraloc option ceramic hip system. The device is indicated for non-cemented use in primary total hip arthroplasty in skeletally mature patients with non-inflammatory degenerative joint disease (nidjd) such as osteoarthritis, avascular necrosis, congenital hip dysplasia, and post-traumatic arthritis.
| Device | DURALOC OPTION CERAMIC HIP SYSTEM |
| Generic Name | Prosthesis, Hip, Semi-constrained, Metal/ceramic/ceramic/metal, Cemented Or Uncemented |
| Applicant | DEPUY ORTHOPAEDICS, INC. |
| Date Received | 2004-05-04 |
| Decision Date | 2005-05-03 |
| Notice Date | 2006-12-20 |
| PMA | P040023 |
| Supplement | S |
| Product Code | MRA |
| Docket Number | 06M-0512 |
| Advisory Committee | Orthopedic |
| Expedited Review | No |
| Combination Product | No |
| Applicant Address | DEPUY ORTHOPAEDICS, INC. 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 |
|---|---|---|
| P040023 | Original Filing | |
| S025 | 2012-10-25 | 30-day Notice |
| S024 | 2012-08-03 | Special (immediate Track) |
| S023 | ||
| S022 | 2012-05-18 | 30-day Notice |
| S021 | 2012-04-18 | Normal 180 Day Track No User Fee |
| S020 | 2012-03-27 | 30-day Notice |
| S019 | 2011-11-09 | Special (immediate Track) |
| S018 | 2011-09-16 | Real-time Process |
| S017 | ||
| S016 | 2009-12-11 | 135 Review Track For 30-day Notice |
| S015 | 2009-12-02 | 135 Review Track For 30-day Notice |
| S014 | 2009-10-19 | Normal 180 Day Track No User Fee |
| S013 | 2008-11-26 | 30-day Notice |
| S012 | 2008-11-18 | Normal 180 Day Track No User Fee |
| S011 | 2008-08-19 | 135 Review Track For 30-day Notice |
| S010 | 2007-10-12 | 30-day Notice |
| S009 | 2007-07-02 | Normal 180 Day Track No User Fee |
| S008 | 2006-09-19 | Special (immediate Track) |
| S007 | 2006-05-04 | Special (immediate Track) |
| S006 | 2006-05-02 | 135 Review Track For 30-day Notice |
| S005 | ||
| S004 | 2006-02-23 | Normal 180 Day Track No User Fee |
| S003 | 2005-11-21 | Special (immediate Track) |
| S002 | 2005-11-10 | Special (immediate Track) |
| S001 | 2005-09-02 | 135 Review Track For 30-day Notice |