PMA P000013S008
- Device
- OSTEONICS ABC / TRIDENT SYSTEMS
- Applicant
- Howmedica Osteonics Corp.
- PMA number
- P000013
- Supplement
- S008
- Product code
- MRA
- Decision date
- 2007-04-26
- 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 A NEW LOCKING MECHANISM DESIGN FOR THE TRIDENT ACETABULAR SYSTEM (TRIDENT ALUMINA INSERTS AND TRIDENT ACETABULAR SHELLS), AS WELL AS ASSOCIATED REVISIONS TO THE PACKAGE INSERT. THIS DESIGN MODIFICATION IS INTENDED TO ALLOW FOR EASE OF INSERTION OF THE ALUMINA CERAMIC INSERT. THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME TRIDENT II ACETABULAR SYSTEM (TRIDENT II ALUMINA INSERTS, TRIDENT II ACETABULAR SHELLS) AND IS INDICATED FOR PATIENTS REQUIRING PRIMARY OR REVISION TOTAL HIP ARTHROPLASTY DUE TO NON-INFLAMMATORY DEGENERATIVE JOINT DISEASE (OSTEOARTHRITIS, AVASCULAR NECROSIS, TRAUMATIC ARTHRITIS, SLIPPED CAPITAL EPIPHYSIS, PELVIC FRACTURE, FEMORAL FRACTURE, FAILED FRACTURE FIXATION, OR DIASTROPHIC VARIANT), OR INFLAMMATORY JOINT DISEASE.
Current openFDA PMA Record#
- Device
- OSTEONICS ABC / TRIDENT SYSTEMS
- Applicant
- Howmedica Osteonics Corp.
- PMA number
- P000013
- Supplement
- S008
- Product code
- MRA
- Generic name
- Prosthesis, hip, semi-constrained, metal/ceramic/ceramic/metal, cemented or uncemented
- Decision date
- 2007-04-26
- Decision code
- APPR
- Date received
- 2006-12-29
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Approval order statement
- APPROVAL FOR A NEW LOCKING MECHANISM DESIGN FOR THE TRIDENT ACETABULAR SYSTEM (TRIDENT ALUMINA INSERTS AND TRIDENT ACETABULAR SHELLS), AS WELL AS ASSOCIATED REVISIONS TO THE PACKAGE INSERT. THIS DESIGN MODIFICATION IS INTENDED TO ALLOW FOR EASE OF INSERTION OF THE ALUMINA CERAMIC INSERT. THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME TRIDENT II ACETABULAR SYSTEM (TRIDENT II ALUMINA INSERTS, TRIDENT II ACETABULAR SHELLS) AND IS INDICATED FOR PATIENTS REQUIRING PRIMARY OR REVISION TOTAL HIP ARTHROPLASTY DUE TO NON-INFLAMMATORY DEGENERATIVE JOINT DISEASE (OSTEOARTHRITIS, AVASCULAR NECROSIS, TRAUMATIC ARTHRITIS, SLIPPED CAPITAL EPIPHYSIS, PELVIC FRACTURE, FEMORAL FRACTURE, FAILED FRACTURE FIXATION, OR DIASTROPHIC VARIANT), OR INFLAMMATORY JOINT DISEASE.