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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
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
Information About: Labeling, Approval Order, Summary of Safety and Effectiveness
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
Post-Approval StudyShow Report Schedule and Study Progress
Supplements: S001 S002 S003 S004 S005 S006 S007 S009