| Note: this medical device has supplements. The device description/function or indication may have changed. Be sure to look at the supplements to get an up-to-date information on device changes. The labeling included below is the version at time of approval of the original PMA or panel track supplement and may not represent the most recent labeling. |
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| Device | TRIDENT SYSTEM |
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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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| Date Received | 03/02/2000 |
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| Decision Date | 02/03/2003 |
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| Product Code |
MRA |
| Docket Number | 03M-0337 |
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| Notice Date | 07/30/2003 |
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| Advisory Committee |
Orthopedic |
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| Expedited Review Granted? | No |
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| Combination Product | No |
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| Recalls | CDRH Recalls |
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Approval Order Statement
APPROVAL FOR THE OSTEONICS ABC SYSTEM AND TRIDENT SYSTEM. THESE DEVICES ARE INDICATED FOR PATIENTS REQUIRING PRIMARY TOTAL HIP ARTHROPLASTY DUE TO PAINFUL DISABLING JOINT DISEASE OF THE HIP RESULTING FROM NON-INFLAMMATORY DEGENERATIVE ARTHRITIS (OSTEOARTHRITIS, AVASCULAR NECROSIS, TRAUMATIC ARTHRITIS, SLIPPED CAPITAL EPIPHYSIS, PELVIC FRACTURE, FEMORAL FRACTURE, FAILED FRACTURE FIXATION, OR DIASTROPHIC VARIANT). |
| Approval Order | Approval Order |
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| Summary | Summary of Safety and Effectiveness |
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| Labeling | Labeling
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| Post-Approval Study | Show Report Schedule and Study Progress |
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| Supplements: |
S001 S002 S003 S004 S005 S006 S008 S009 S010 S011 S012
S013 S014 S015 S016 S017 S018 S019 S020 S021 S022 S023 S024
S025 |
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