Premarket Approval (PMA)

Note: this medical device has supplements. The device description/function or indication may have changed. Be sure to look at the supplements to get an up-to-date information on device changes. The labeling included below is the version at time of approval of the original PMA or panel track supplement and may not represent the most recent labeling.

• Device: PINNACLE COMPLETE ACETABULAR HIP SYSTEM
• Generic Name: Prosthesis, hip, semi-constrained, ceramic-on-metal articulation
• Applicant: DePuy Orthopaedics, Inc.; P.O. Box 988; 700 Orthopaedic Dr.; Warsaw, IN 46581
• PMA Number: P090002
• Date Received: 02/17/2009
• Decision Date: 06/13/2011
• Withdrawal Date: 09/05/2013
• Product Code: OVO
• Docket Number: 11M-0470
• Notice Date: 06/15/2011
• Advisory Committee: Orthopedic
• Clinical Trials: NCT00208494
• Expedited Review Granted?: No
• Combination Product: No
• Predetermined Change Control Plan Authorized: 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 Study: Show Report Schedule and Study Progress
• Supplements: S001 S002 S003 S004 S005 S006 S007 S009