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U.S. Department of Health and Human Services

Premarket Approval (PMA)

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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.
 
DeviceTRIDENT SYSTEM
Generic Nameprosthesis, hip, semi-constrained, metal/ceramic/ceramic/metal, cemented or uncemented
ApplicantHOWMEDICA OSTEONICS CORP.
325 corporate drive
mahwah, NJ 07430
PMA NumberP000013
Date Received03/02/2000
Decision Date02/03/2003
Product Code MRA 
Docket Number 03M-0337
Notice Date 07/30/2003
Advisory Committee Orthopedic
Expedited Review Granted? No
Combination ProductNo
RecallsCDRH Recalls
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 OrderApproval Order
SummarySummary of Safety and Effectiveness
LabelingLabeling
Post-Approval StudyShow Report Schedule and Study Progress
Supplements:  S001 S002 S003 S004 S005 S006 S008 S009 S010 S011 S012 
S013 S014 S015 S016 S017 S018 S019 S020 
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