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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 may have changed. Be sure to look at the supplements to get an up-to-date view of this device.
Classification Nameprosthesis, hip, semi-constrained, ceramic-on-metal articulation
Generic Nameprosthesis, hip, semi-constrained, ceramic-on-metal articulation
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[ Registered Establishments with OVO ]
Docket Number 11M-0470
Notice Date 06/15/2011
Advisory Committee Orthopedic
Clinical Trials NCT00208494
Expedited Review Granted? No
Combination Product No
Recalls CDRH 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 Order Approval Order
Summary Summary of Safety and Effectiveness
Labeling Labeling
Post-Approval StudyShow Report Schedule and Study Progress
Supplements: S001 S002 S003 S004 S005 S006 S007 S009