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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 CERAMAX CERAMIC TOTAL HIP SYSTEM
Generic NameProsthesis, hip, semi-constrained, metal/ceramic/ceramic/metal, cemented or uncemented
ApplicantDEPUY ORTHOPAEDICS, INC.
700 ORTHOPAEDIC DRIVE
WARSAW, IN 46582
PMA NumberP070026
Supplement NumberS003
Date Received07/18/2011
Decision Date09/16/2011
Product Code MRA 
Advisory Committee Orthopedic
Supplement TypeReal-Time Process
Supplement Reason Change Design/Components/Specifications/Material
Expedited Review Granted? No
Combination ProductNo
Approval Order Statement  
APPROVAL FOR THE ADDITION OF THE TRIO-LOCK BPS (BONE PRESERVING HIP STEM) AND 28 MM CERAMIC FEMORAL HEADS WITH A 12/14 TAPER AND +1.5 MM, +5 MM, AND 8.5 MM OFFSET AS COMPATIBLE MODULAR COMPONENTS TO THE SYSTEM, AND MINOR LABELING CHANGES TO THE DEVICE PACKAGE INSERT AND SURGICAL TECHNIQUE. THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME DEPUY CERAMAX CERAMIC TOTAL HIP SYSTEM AND IS INDICATED FOR NONCEMENTED USE IN SKELETALLY MATURE INDIVIDUALS UNDERGOING PRIMARY TOTAL HIP REPLACEMENT SURGERY FOR REHABILITATION OF HIPS DAMAGED AS A RESULT OF NONINFLAMMATORY DEGENERATIVE JOINT DISEASE (NIDJD) OR ANY OF ITS COMPOSITE DIAGNOSES OF OSTEOARTHRITIS, AVASCULAR NECROSIS, AND POST TRAUMATIC ARTHRITIS.
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