Prosthesis, Hip, Semi-Constrained, Ceramic-On-Metal Articulation
Basic Information
- Device Name
- Prosthesis, Hip, Semi-Constrained, Ceramic-On-Metal Articulation
- Trade Name
- PINNACLE COMPLETE ACETABULAR HIP SYSTEM
- PMA Number
- P090002
- Device Class
- FDA Class 3
- Product Code
- OVO
- Generic Name
- Prosthesis, hip, semi-constrained, ceramic-on-metal articulation
- Medical Specialty
- Unknown
- Advisory Committee
- Orthopedic
- Decision
- Approved (Withdrawn)
- Decision Code
- APWD
- Decision Date
- June 13, 2011
- Date Received
- February 17, 2009
- Expedited Review
- N
- Docket Number
- 11M-0470
Advisory Committee 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.
Classifications
This FDA Pre-Market Approval entry is associated with 1 FDA classification via its product code.
| Product Code | Device Name | Device Class | Medical Specialty |
|---|---|---|---|
| OVO | Prosthesis, Hip, Semi-Constrained, Ceramic-On-Metal Articulation | FDA class 3 | Unknown |