Approval for the addition of intermediate sizes for both the femoral head (42mm, 46mm, 50mm, and 54mm) and the corresponding acetabular cup components within the product line for the cormet hip resurfacing system and revisions to the cormet hip resurfacing labeling to reflect these additional intermediate-sized components. The device is indicated 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; 2) inflammatory arthritis such as rheumatoid arthritis.
| 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 | 2007-09-04 |
| Decision Date | 2007-11-02 |
| PMA | P050016 |
| Supplement | S002 |
| Product Code | NXT |
| Advisory Committee | Orthopedic |
| Supplement Type | Real-time Process |
| Supplement Reason | Change Design/components/specifications/material |
| 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