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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.
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 46581-0988
PMA NumberP040023
Date Received05/04/2004
Decision Date05/03/2005
Withdrawal Date 04/03/2014
Product Code
MRA[ Registered Establishments with MRA ]
Docket Number 06M-0512
Notice Date 12/20/2006
Advisory Committee Orthopedic
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for the duraloc option ceramic hip system. The device is indicated for non-cemented use in primary total hip arthroplasty in skeletally mature patients with non-inflammatory degenerative joint disease (nidjd) such as osteoarthritis, avascular necrosis, congenital hip dysplasia, 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 S002 S003 S004 S006 S007 S008 S009 S010 
S011 S012 S013 S014 S015 S016 S018 S019 S020 
S021 S022 S024 S025