Premarket Approval (PMA)

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.

• Trade Name: PINNACLE COMPLETE ACETABULAR HIP SYSTEM
• Classification Name: prosthesis, hip, semi-constrained, ceramic-on-metal articulation
• Applicant: DEPUY ORTHOPAEDICS, INC.
• PMA Number: P090002
• Date Received: 02/17/2009
• Decision Date: 06/13/2011
• 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

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 joint disease (nidjd) and its composite diagnoses of osteoarthritis (oa) or post-traumatic arthritis. 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 Study

Show Report Schedule and Study Progress

• Supplements: S001 S002 S003 S004 S005 S006 ; S007