PMA P050016S007
- Device
- CORMET HIP RESURFACING SYSTEM
- Applicant
- Corin USA
- PMA number
- P050016
- Supplement
- S007
- Product code
- NXT
- Decision date
- 2011-01-13
- Classification
- Prosthesis, Hip, Semi-constrained, Metal/metal, Resurfacing
- Generic name
- Prosthesis, hip, semi-constrained, metal/metal, resurfacing
- Approval order 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.
Current openFDA PMA Record#
- Device
- CORMET HIP RESURFACING SYSTEM
- Applicant
- Corin USA
- PMA number
- P050016
- Supplement
- S007
- Product code
- NXT
- Generic name
- Prosthesis, hip, semi-constrained, metal/metal, resurfacing
- Decision date
- 2011-01-13
- Decision code
- APPR
- Date received
- 2010-11-19
- Supplement type
- Real-Time Process
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Approval order 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.