Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Ceramic/Metal, Cemented Or Uncemented
Basic Information
- Device Name
- Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Ceramic/Metal, Cemented Or Uncemented
- Trade Name
- OSTEONICS ABC / TRIDENT SYSTEMS
- PMA Number
- P000013
- Supplement Number
- S008
- Device Class
- FDA Class 3
- Product Code
- MRA
- Generic Name
- Prosthesis, hip, semi-constrained, metal/ceramic/ceramic/metal, cemented or uncemented
- Medical Specialty
- Unknown
- Advisory Committee
- Orthopedic
- Decision
- Approved
- Decision Code
- APPR
- Decision Date
- April 26, 2007
- Date Received
- December 29, 2006
- Supplement Type
- Real-Time Process
- Supplement Reason
- Change Design/Components/Specifications/Material
- Expedited Review
- N
Advisory Committee Statement
APPROVAL FOR A NEW LOCKING MECHANISM DESIGN FOR THE TRIDENT ACETABULAR SYSTEM (TRIDENT ALUMINA INSERTS AND TRIDENT ACETABULAR SHELLS), AS WELL AS ASSOCIATED REVISIONS TO THE PACKAGE INSERT. THIS DESIGN MODIFICATION IS INTENDED TO ALLOW FOR EASE OF INSERTION OF THE ALUMINA CERAMIC INSERT. THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME TRIDENT II ACETABULAR SYSTEM (TRIDENT II ALUMINA INSERTS, TRIDENT II ACETABULAR SHELLS) AND IS INDICATED FOR PATIENTS REQUIRING PRIMARY OR REVISION TOTAL HIP ARTHROPLASTY DUE TO NON-INFLAMMATORY DEGENERATIVE JOINT DISEASE (OSTEOARTHRITIS, AVASCULAR NECROSIS, TRAUMATIC ARTHRITIS, SLIPPED CAPITAL EPIPHYSIS, PELVIC FRACTURE, FEMORAL FRACTURE, FAILED FRACTURE FIXATION, OR DIASTROPHIC VARIANT), OR INFLAMMATORY JOINT DISEASE.
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 |
|---|---|---|---|
| MRA | Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Ceramic/Metal, Cemented Or Uncemented | FDA class 3 | Unknown |