Prosthesis, Hip, Semi-Constrained, Metal/Metal, Resurfacing
Basic Information
- Device Name
- Prosthesis, Hip, Semi-Constrained, Metal/Metal, Resurfacing
- Trade Name
- CONSERVE PLUS TOTAL RESURFACING HIP SYSTEM
- PMA Number
- P030042
- 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- Approved (Withdrawn)
- Decision Code
- APWD
- Decision Date
- November 3, 2009
- Date Received
- September 30, 2003
- Expedited Review
- Y
- Docket Number
- 09M-0540
Advisory Committee Statement
APPROVAL FOR THECONSERVE PLUS TOTAL RESURFACING HIP SYSTEM.THE CONSERVE PLUS TOTAL RESURFACING HIP SYSTEM IS A SINGLE USE DEVICE INTENDED FOR HYBRID FIXATION UTILIZING CEMENTED FEMORAL HEAD COMPONENT AND CEMENTLESS ACETABULAR COMPONENT. THECONSERVE PLUS TOTAL RESURFACING HIP SYSTEM IS INTENDED FOR USE IN RESURFACING HIPARTHROPLASTY FOR REDUCTION OR RELIEF OF PAIN AND/OR IMPROVED HIP FUNCTION IN SKELETALLY MATUREPATIENTS HAVING THE FOLLOWING CONDITIONS:1) NON-INFLAMMATORY ARTHRITIS (DEGENERATIVE JOINT DISEASE) SUCH AS OSTEOARTHRITIS,TRAUMATIC ARTHRITIS, AVASCULAR NECROSIS, OR DYSPLASIA/ DEVELOPMENTAL DISLOCATION OF THEHIP (DDH), OR2) INFLAMMATORY ARTHRITIS SUCH AS RHEUMATOID ARTHRITIS.THE CONSERVE PLUS TOTAL RESURFACING HIP SYSTEM IS INTENDED FOR PATIENTS WHO, DUE TO THEIRRELATIVELY YOUNGER AGE OR INCREASED ACTIVITY LEVEL, MAY NOT BE SUITABLE FOR TRADITIONAL TOTAL HIPARTHROPLASTY DUE TO AN INCREASED POSSIBILITY OF REQUIRING FUTURE 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 |