PMA P050016S002
- Device
- CORMET HIP RESURFACING SYSTEM
- Applicant
- Corin USA
- PMA number
- P050016
- Supplement
- S002
- Product code
- NXT
- Decision date
- 2007-11-02
- Classification
- Prosthesis, Hip, Semi-constrained, Metal/metal, Resurfacing
- Generic name
- Prosthesis, hip, semi-constrained, metal/metal, resurfacing
- Approval order statement
- APPROVAL FOR THE ADDITION OF INTERMEDIATE SIZES FOR BOTH THE FEMORAL HEAD (42MM, 46MM, 50MM, AND 54MM) AND THE CORRESPONDING ACETABULAR CUP COMPONENTS WITHIN THE PRODUCT LINE FOR THE CORMET HIP RESURFACING SYSTEM AND REVISIONS TO THE CORMET HIP RESURFACING LABELING TO REFLECT THESE ADDITIONAL INTERMEDIATE-SIZED COMPONENTS. THE DEVICE IS INDICATED 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; 2) INFLAMMATORY ARTHRITIS SUCH AS RHEUMATOID ARTHRITIS.
Current openFDA PMA Record#
- Device
- CORMET HIP RESURFACING SYSTEM
- Applicant
- Corin USA
- PMA number
- P050016
- Supplement
- S002
- Product code
- NXT
- Generic name
- Prosthesis, hip, semi-constrained, metal/metal, resurfacing
- Decision date
- 2007-11-02
- Decision code
- APPR
- Date received
- 2007-09-04
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Approval order statement
- APPROVAL FOR THE ADDITION OF INTERMEDIATE SIZES FOR BOTH THE FEMORAL HEAD (42MM, 46MM, 50MM, AND 54MM) AND THE CORRESPONDING ACETABULAR CUP COMPONENTS WITHIN THE PRODUCT LINE FOR THE CORMET HIP RESURFACING SYSTEM AND REVISIONS TO THE CORMET HIP RESURFACING LABELING TO REFLECT THESE ADDITIONAL INTERMEDIATE-SIZED COMPONENTS. THE DEVICE IS INDICATED 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; 2) INFLAMMATORY ARTHRITIS SUCH AS RHEUMATOID ARTHRITIS.