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U.S. Department of Health and Human Services

Premarket Approval (PMA)
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Note: This medical device record is a PMA supplement. A supplement may have changed the device description/function or indication from that approved in the original PMA. Be sure to look at the original PMA record for more information.
 
DeviceDEPUY PINNACLE COMPLETE ACETABULAR HIP SYSTEM
Generic NameProsthesis, hip, semi-constrained, ceramic-on-metal articulation
ApplicantDePuy Orthopaedics, Inc.
P.O. Box 988
700 Orthopaedic Dr.
Warsaw, IN 46581
PMA NumberP090002
Supplement NumberS002
Date Received01/19/2012
Decision Date04/17/2012
Withdrawal Date09/05/2013
Product Code OVO 
Advisory Committee Orthopedic
Supplement TypeReal-Time Process
Supplement Reason Change Design/Components/Specifications/Material
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
APPROVAL FOR THE ADDITION OF THE TRILOCK BPS (BONE PRESERVING HIP STEM) TO THE LIST OF COMPATIBLE FEMORAL STEM COMPONENTS. THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME DEPUY PINNACLE COMPLETE ACETABULAR HIP SYSTEM AND IS INDICATED AS A SINGLE USE DEVICE INTENDED FOR UNCEMENTED FIXATION. THE DEVICE 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 JOINT DISEASE (NIDJD) AND ITS COMPOSITE DIAGNOSES OF OSTEOARTHRITIS (OA) OR POST-TRAUMATIC ARTHRITIS. THE DEVICE¿S INSERTS (PINNACLE ULTAMET) ARE ONLY INTENDED FOR USE WITH DEPUY¿S FEMORAL AND ACETABULAR COMPONENTS HAVING MATCHING OUTER AND INNER DIAMETERS.
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