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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.
 
Device PINNACLE COMPLETE ACETABULAR HIP SYSTEM
Generic NameProsthesis, hip, semi-constrained, ceramic-on-metal articulation
ApplicantDEPUY ORTHOPAEDICS, INC.
P.O BOX 988
700 ORTHOPAEDIC DRIVE
WARSAW, IN 46581-0988
PMA NumberP090002
Date Received02/17/2009
Decision Date06/13/2011
Withdrawal Date 09/05/2013
Product Code OVO 
Docket Number 11M-0470
Notice Date 06/15/2011
Advisory Committee Orthopedic
Clinical TrialsNCT00208494
Expedited Review Granted? No
Combination ProductNo
RecallsCDRH Recalls
Approval Order Statement  
APPROVAL FOR THE PINNACLE COMPLETE ACETABULAR HIP SYSTEM. THIS DEVICE IS INDICATED FOR:THE PINNACLE COMPLETE ACETABULAR HIP SYSTEM IS A SINGLE USE DEVICE INTENDED FOR UNCEMENTED FIXATION. THE PINNACLE COMPLETE ACETABULAR HIP SYSTEM IS INTENDED AS A PRIMARY JOINT REPLACEMENT PROSTHESIS IN TOTAL HIP ARTHROPLASTY FOR SKELETALLY MATURE PATIENTS SUFFERING AT LEAST MODERATE PAIN IN THE HIP JOINT FROM NON-INFLAMMATORY DEGENERATIVE JOINTDISEASE (NIDJD) AND ITS COMPOSITE DIAGNOSES OF OSTEOARTHRITIS (OA) OR POST-TRAUMATICARTHRITIS. PINNACLE COMPLETE ACETABULAR HIP SYSTEM'S INSERTS (PINNACLE ULTAMET) ARE ONLY INTENDED FOR USE WITH DEPUY'S FEMORAL AND ACETABULAR COMPONENTS HAVING MATCHING OUTER AND INNER DIAMETERS.
Approval OrderApproval Order
SummarySummary of Safety and Effectiveness
LabelingLabeling
Post-Approval StudyShow Report Schedule and Study Progress
Supplements:  S001 S002 S003 S004 S005 S006 S007 S009 
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