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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/function or indication may have changed. Be sure to look at the supplements to get an up-to-date information on device changes. The labeling included below is the version at time of approval of the original PMA or panel track supplement and may not represent the most recent labeling.
 
DeviceDURALOC OPTION 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 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 
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