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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 supplement. The device description may have changed. Be sure to look at the original PMA to get an up-to-date view of this device.
 
Trade NameCORMET HIP RESURFACING SYSTEM
Classification Nameprosthesis, hip, semi-constrained, metal/metal, resurfacing
Generic Namemetal-on-metal hip resurfacing system
ApplicantCORIN U.S.A.
PMA NumberP050016
Supplement NumberS002
Date Received09/04/2007
Decision Date11/02/2007
Product Code
NXT[ Registered Establishments with NXT ]
Advisory Committee Orthopedic
Supplement Typereal-time process
Supplement Reason design change - minor
Expedited Review Granted? No
Combination Product No
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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