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 novation ceramic articulation hip system. This device is indicated for primary total hip arthroplasty in skeletally mature patients with non-inflammatory degenerative joint disease such as osteoarthritis, avascular necrosis, congenital hip dysplasia, and traumatic arthritis.
| Device | NOVATION CERAMIC ARTICULATION HIP SYSTEM |
| Classification Name | Prosthesis, Hip, Semi-constrained, Metal/ceramic/ceramic/metal, Cemented Or Uncemented |
| Generic Name | Prosthesis, Hip, Semi-constrained, Metal/ceramic/ceramic/metal, Cemented Or Uncemented |
| Applicant | EXACTECH, INC. |
| Date Received | 2005-10-27 |
| Decision Date | 2007-07-05 |
| Notice Date | 2007-07-20 |
| PMA | P050039 |
| Supplement | S |
| Product Code | MRA |
| Docket Number | 07M-0287 |
| Advisory Committee | Orthopedic |
| Expedited Review | No |
| Combination Product | No |
| Applicant Address | EXACTECH, INC. 2320 N.w. 66th Ct. gainesville, FL 32653 |
| 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 |
|---|---|---|
| P050039 | Original Filing | |
| S021 | 2016-09-01 | Normal 180 Day Track No User Fee |
| S020 | 2016-09-01 | 30-day Notice |
| S019 | 2016-06-24 | 30-day Notice |
| S018 | 2015-12-09 | 30-day Notice |
| S017 | 2015-07-06 | Normal 180 Day Track No User Fee |
| S016 | 2014-05-20 | 30-day Notice |
| S015 | 2013-01-11 | 30-day Notice |
| S014 | 2012-11-14 | 30-day Notice |
| S013 | 2012-10-04 | 30-day Notice |
| S012 | 2012-09-18 | 30-day Notice |
| S011 | 2012-08-30 | 30-day Notice |
| S010 | 2012-07-24 | 30-day Notice |
| S009 | 2012-03-28 | Special (immediate Track) |
| S008 | 2012-03-26 | 135 Review Track For 30-day Notice |
| S007 | 2011-10-07 | 135 Review Track For 30-day Notice |
| S006 | ||
| S005 | 2011-03-11 | Special (immediate Track) |
| S004 | 2009-09-15 | Normal 180 Day Track No User Fee |
| S003 | 2009-08-19 | 30-day Notice |
| S002 | 2008-07-31 | 135 Review Track For 30-day Notice |
| S001 | 2007-10-31 | Normal 180 Day Track No User Fee |