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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.
Classification Nameprosthesis, hip, semi-constrained, metal/ceramic/ceramic/metal, cemented or uncemented
Generic Nameprosthesis, hip, semi-constrained, metal/ceramic/ceramic/metal, cemented or uncemented
700 orthopaedic drive
warsaw, IN 46582
PMA NumberP070026
Supplement NumberS004
Date Received11/01/2011
Decision Date04/02/2013
Product Code
MRA[ Registered Establishments with MRA ]
Docket Number 13M-0462
Notice Date 04/24/2013
Advisory Committee Orthopedic
Clinical Trials NCT00953719
Supplement Typepanel track
Supplement Reason labeling change - indications/instructions/shelf life/tradename
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for depuy ceramax ceramic total hip system. This device is indicated for noncemented use in skeletally mature individuals undergoing primary total hip replacement surgery for rehabilitationof hips damaged as a result of noninflammatory degenerative joint disease (nidjd) or any of its composite diagnoses of osteoarthritis, avascular necrosis, and post-traumatic arthritis.
Approval Order Approval Order
Summary Summary of Safety and Effectiveness
Labeling Labeling
Post-Approval StudyShow Report Schedule and Study Progress