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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 supplement. The device description may have changed. Be sure to look at the original PMA to get an up-to-date view of this device.
Classification Nameprosthesis, hip, semi-constrained, ceramic-on-metal articulation
PMA NumberP090002
Supplement NumberS002
Date Received01/19/2012
Decision Date04/17/2012
Product Code
OVO[ Registered Establishments with OVO ]
Advisory Committee Orthopedic
Supplement Typereal-time process
Supplement Reason change design/components/specifications - component
Expedited Review Granted? No
Combination Product No
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.