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U.S. Department of Health and Human Services

Premarket Approval (PMA)
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Note: This medical device record is a PMA supplement. A supplement may have changed the device description/function or indication from that approved in the original PMA. Be sure to look at the original PMA record for more information.
 
DeviceCORMET HIP RESURFACING SYSTEM
Generic NameProsthesis, hip, semi-constrained, metal/metal, resurfacing
ApplicantCorin USA
480 Paramount Dr.
Raynham, MA 02767
PMA NumberP050016
Supplement NumberS002
Date Received09/04/2007
Decision Date11/02/2007
Product Code NXT 
Advisory Committee Orthopedic
Supplement TypeReal-Time Process
Supplement Reason Change Design/Components/Specifications/Material
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
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.
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