PMA P030027S002
- Device
- CERAMIC TRANSCEND ARTICULATION SYSTEM
- Applicant
- Microport Orthopedics, Inc.
- PMA number
- P030027
- Supplement
- S002
- Product code
- MRA
- Decision date
- 2006-06-23
- Classification
- Prosthesis, Hip, Semi-constrained, Metal/ceramic/ceramic/metal, Cemented Or Uncemented
- Generic name
- Prosthesis, hip, semi-constrained, metal/ceramic/ceramic/metal, cemented or uncemented
- Approval order statement
- APPROVAL FOR THE ADDITION OF AN INTERMEDIATE CERAMIC LINER SIZE (36/48G); THREE REPLACEMENT 36MM OD CERAMIC HEADS WITH CONSISTENT OFFSET (-3.5 MM, 0 MM, AND +3.5 MM); AND FEMORAL STEMS AND ACETABULAR SHELLS AS SPECIFIED IN SUBMISSIONS RECEIVED MARCH 8, 2006 AND JUNE 21, 2006 WHICH HAVE BEEN ROUND SUBSTANTIALLY EQUIVALENT VIA THE 510(K) PROCESS. THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME CERAMIC LINEAGE/ TRANSCEND ARTICULATION SYSTEM AND IS INDICATED FOR USE IN PRIMARY TOTAL HIP ARTHROPLASTY IN SKELETALLY MATURE PATIENTS WITH NON-INFLAMMATORY DEGENERATIVE JOINT DISEASE SUCH AS OSTEOARTHRITIS, AVASCULAR NECROSIS, CONGENITAL HIP DYSPLASIA, AND TRAUMATIC ARTHRITIS.
Current openFDA PMA Record#
- Device
- CERAMIC TRANSCEND ARTICULATION SYSTEM
- Applicant
- Microport Orthopedics, Inc.
- PMA number
- P030027
- Supplement
- S002
- Product code
- MRA
- Generic name
- Prosthesis, hip, semi-constrained, metal/ceramic/ceramic/metal, cemented or uncemented
- Decision date
- 2006-06-23
- Decision code
- APPR
- Date received
- 2006-03-08
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Approval order statement
- APPROVAL FOR THE ADDITION OF AN INTERMEDIATE CERAMIC LINER SIZE (36/48G); THREE REPLACEMENT 36MM OD CERAMIC HEADS WITH CONSISTENT OFFSET (-3.5 MM, 0 MM, AND +3.5 MM); AND FEMORAL STEMS AND ACETABULAR SHELLS AS SPECIFIED IN SUBMISSIONS RECEIVED MARCH 8, 2006 AND JUNE 21, 2006 WHICH HAVE BEEN ROUND SUBSTANTIALLY EQUIVALENT VIA THE 510(K) PROCESS. THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME CERAMIC LINEAGE/ TRANSCEND ARTICULATION SYSTEM AND IS INDICATED FOR USE IN PRIMARY TOTAL HIP ARTHROPLASTY IN SKELETALLY MATURE PATIENTS WITH NON-INFLAMMATORY DEGENERATIVE JOINT DISEASE SUCH AS OSTEOARTHRITIS, AVASCULAR NECROSIS, CONGENITAL HIP DYSPLASIA, AND TRAUMATIC ARTHRITIS.