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U.S. Department of Health and Human Services

Premarket Approval (PMA)

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Note: this medical device has supplements. The device description may have changed. Be sure to look at the supplements to get an up-to-date view of this device.
 
Trade NameKERAMOS CERAMIC/CERAMIC TOTAL HIP SYSTEM
Classification Nameprosthesis, hip, semi-constrained, metal/ceramic/ceramic/metal, cemented or uncemented
Generic Nameceramic/ceramic hip
ApplicantDJO SURGICAL
PMA NumberN980003
Date Received03/08/1998
Decision Date11/26/2003
Product Code
MRA[ Registered Establishments with MRA ]
Advisory Committee Orthopedic
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for the product development protocol (pdp) for the keramos ceramic/ceramic total hip system. This device is indicated for usc in patients requiring primary total hip arthroplasty for the treatment of inflammatory tissue disorders and noninflammatory degenerative joint disease, including osteoarthritis, post-traumatic arthritis or secondary arthritis, and avascular necrosis.
Supplements: S007 
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