Approval for modifications to the labeling for the cormet hip resurfacing system which is indicated for hybrid fixation: cemented femoral head and cementless acetabular component. The cormet hip resurfacing system is intended for use in resurfacing hip arthroplasty for reduction or relief of pain and/or improved hip function in skeletally mature patients having the following conditions: 1) non- inflammatory degenerative arthritis such as osteoarthritis and avascular necrosis; and 2) inflammatory arthritis such as rheumatoid arthritis. The cormet hip resurfacing system is intended for patients who, due to their relatively younger age or increased activity level, may not be suitable for traditional total hip arthroplasty due to an increased possibility of requiring ipsilateral hip joint revision.
| Device | CORMET HIP RESURFACING SYSTEM |
| Classification Name | Prosthesis, Hip, Semi-constrained, Metal/metal, Resurfacing |
| Generic Name | Prosthesis, Hip, Semi-constrained, Metal/metal, Resurfacing |
| Applicant | CORIN U.S.A. |
| Date Received | 2010-11-19 |
| Decision Date | 2011-01-13 |
| PMA | P050016 |
| Supplement | S007 |
| Product Code | NXT |
| Advisory Committee | Orthopedic |
| Supplement Type | Real-time Process |
| Supplement Reason | Labeling Change - Indications/instructions/shelf Life/tradename |
| Expedited Review | No |
| Combination Product | No |
| Applicant Address | CORIN U.S.A. 12750 Citrus Park Lane suite 120 tampa, FL 33607 |
Supplemental Filings
| Supplement Number | Date | Supplement Type |
|---|
| P050016 | | Original Filing |
| S012 |
2019-01-25 |
Normal 180 Day Track No User Fee |
| S011 |
2016-07-06 |
Normal 180 Day Track No User Fee |
| S010 |
2013-12-13 |
Real-time Process |
| S009 |
2012-02-14 |
Real-time Process |
| S008 |
2011-10-11 |
30-day Notice |
| S007 |
2010-11-19 |
Real-time Process |
| S006 |
2009-11-02 |
Real-time Process |
| S005 |
2009-11-02 |
Special (immediate Track) |
| S004 |
2008-09-29 |
Normal 180 Day Track No User Fee |
| S003 |
2008-05-16 |
Real-time Process |
| S002 |
2007-09-04 |
Real-time Process |
| S001 |
2007-07-16 |
Normal 180 Day Track No User Fee |
NIH GUDID Devices