Prosthesis, Hip, Semi-Constrained, Metal/Metal, Resurfacing
Basic Information
- Device Name
- Prosthesis, Hip, Semi-Constrained, Metal/Metal, Resurfacing
- Trade Name
- CORMET HIP RESURFACING SYSTEM
- PMA Number
- P050016
- Supplement Number
- S007
- Device Class
- FDA Class 3
- Product Code
- NXT
- Generic Name
- Prosthesis, hip, semi-constrained, metal/metal, resurfacing
- Medical Specialty
- Unknown
- Advisory Committee
- Orthopedic
- Decision
- Approved
- Decision Code
- APPR
- Decision Date
- January 13, 2011
- Date Received
- November 19, 2010
- Supplement Type
- Real-Time Process
- Supplement Reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Expedited Review
- N
Advisory Committee Statement
APPROVAL FOR MODIFICATIONS TO THE LABELING FOR THE CORMET HIP RESURFACING SYSTEM WHICH IS INDICATED FOR HYBRID FIXATION: CEMENTED FEMORAL HEAD AND CEMENTLESS ACETABULAR COMPONENT. THE CORMET HIP RESURFACING SYSTEM IS INTENDED FOR USE IN RESURFACING HIP ARTHROPLASTY FOR REDUCTION OR RELIEF OF PAIN AND/OR IMPROVED HIP FUNCTION IN SKELETALLY MATURE PATIENTS HAVING THE FOLLOWING CONDITIONS: 1) NON- INFLAMMATORY DEGENERATIVE ARTHRITIS SUCH AS OSTEOARTHRITIS AND AVASCULAR NECROSIS; AND 2) INFLAMMATORY ARTHRITIS SUCH AS RHEUMATOID ARTHRITIS. THE CORMET HIP RESURFACING SYSTEM IS INTENDED FOR PATIENTS WHO, DUE TO THEIR RELATIVELY YOUNGER AGE OR INCREASED ACTIVITY LEVEL, MAY NOT BE SUITABLE FOR TRADITIONAL TOTAL HIP ARTHROPLASTY DUE TO AN INCREASED POSSIBILITY OF REQUIRING IPSILATERAL HIP JOINT REVISION.
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 |
|---|---|---|---|
| NXT | Prosthesis, Hip, Semi-Constrained, Metal/Metal, Resurfacing | FDA class 3 | Unknown |