Prosthesis, Hip, Semi-Constrained, Ceramic-On-Metal Articulation
Basic Information
- Device Name
- Prosthesis, Hip, Semi-Constrained, Ceramic-On-Metal Articulation
- Trade Name
- DEPUY PINNACLE COMPLETE ACETABULAR HIP SYSTEM
- PMA Number
- P090002
- Supplement Number
- S002
- 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
- Decision Code
- APPR
- Decision Date
- April 17, 2012
- Date Received
- January 19, 2012
- Supplement Type
- Real-Time Process
- Supplement Reason
- Change Design/Components/Specifications/Material
- Expedited Review
- N
Advisory Committee Statement
APPROVAL FOR THE ADDITION OF THE TRILOCK BPS (BONE PRESERVING HIP STEM) TO THE LIST OF COMPATIBLE FEMORAL STEM COMPONENTS. THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME DEPUY PINNACLE COMPLETE ACETABULAR HIP SYSTEM AND IS INDICATED AS A SINGLE USE DEVICE INTENDED FOR UNCEMENTED FIXATION. THE DEVICE 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. THE DEVICE¿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 |