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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.
 
DeviceTRILOGY AB ACETABULAR SYSTEM
Generic Nameprosthesis, hip, semi-constrained, metal/ceramic/ceramic/metal, cemented or uncemented
ApplicantZIMMER, INC.
p.o. box 708
warsaw, IN 46581-0708
PMA NumberP040048
Date Received12/14/2004
Decision Date06/28/2006
Withdrawal Date 08/29/2012
Product Code MRA 
Docket Number 07M-0259
Notice Date 06/28/2007
Advisory Committee Orthopedic
Expedited Review Granted? No
Combination ProductNo
RecallsCDRH Recalls
Approval Order Statement  
APPROVAL FOR THE TRILOGY AB ACETABULAR SYSTEM. THE DEVICE IS INDICATED FOR EITHER CEMENTED OR NONCEMENTED USE IN SKELETALLY MATURE INDIVIDUALS UNDERGOING PRIMARY SURGERY FOR REHABILITATING HIPS DAMAGED AS A RESULT OF NONINFLAMMATORY DEGENERATIVE JOINT DISEASE (NIDJD) SUCH AS OSTEOARTHRITIS, AVASCULAR NECROSIS, CONGENITAL HIP DYSPLASIA, AND TRAUMATIC ARTHRITIS.
Approval OrderApproval Order
SummarySummary of Safety and Effectiveness
LabelingLabeling
Post-Approval StudyShow Report Schedule and Study Progress
Supplements:  S001 S002 S003 S004 S005 S008 S009 S010 S011 S012 S014 
S015 S016 S017 
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