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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.
 
DeviceCERAMAX CERAMIC HIP SYSTEM
Classification Nameprosthesis, hip, semi-constrained, metal/ceramic/ceramic/metal, cemented or uncemented
Generic Nameprosthesis, hip, semi-constrained, metal/ceramic/ceramic/metal, cemented or uncemented
Applicant
DEPUY ORTHOPAEDICS, INC.
700 orthopaedic drive
warsaw, IN 46582
PMA NumberP070026
Date Received10/01/2007
Decision Date12/23/2010
Product Code
MRA[ Registered Establishments with MRA ]
Docket Number 11M-0035
Notice Date 01/25/2011
Advisory Committee Orthopedic
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for the ceramax ceramic total hip system. This device is indicated for noncemented use in skeletally mature individuals undergoing primary total hip replacement surgery for rehabilitation of 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
Supplements: S001 S003 S004 S005 S006 S007 S008 S009 S010 
S011 S012 S013 S014 S016 S017 S018 S019 S020 
S021 S022 S023 S024 S025 S026 S028 S029 S030 
S031 S032 S033 
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