| Note: This medical device record is a PMA supplement. A supplement may have changed the device description/function or indication from that approved in the original PMA. Be sure to look at the original PMA record for more information. |
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| Device | OSTEONICS ABC / TRIDENT SYSTEMS |
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| Generic Name | Prosthesis, hip, semi-constrained, metal/ceramic/ceramic/metal, cemented or uncemented |
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| Applicant | HOWMEDICA OSTEONICS CORP.
325 Corporate Drive
Mahwah, NJ 07430 |
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| PMA Number | P000013 |
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| Supplement Number | S008 |
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| Date Received | 12/29/2006 |
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| Decision Date | 04/26/2007 |
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| Product Code |
MRA |
| Advisory Committee |
Orthopedic |
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| Supplement Type | Real-Time Process |
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| Supplement Reason | Change Design/Components/Specifications/Material |
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| Expedited Review Granted? | No |
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| Combination Product | No |
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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. |
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