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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.
 
DeviceSCANDINAVIAN TOTAL ANKLE REPLACEMENT SYSTEM (S.T.A.R.ANKLE)
Generic NameProsthesis, ankle, uncemented, non-constrained
ApplicantDjo Global
9800 Metric Blvd.
Austin, TX 78758
PMA NumberP050050
Date Received12/07/2005
Decision Date05/27/2009
Product Code NTG 
Docket Number 11M-0323
Notice Date 05/10/2011
Advisory Committee Orthopedic
Expedited Review Granted? Yes
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
APPROVAL FOR THE STAR ANKLE. THE DEVICE IS INDICATED FOR USE AS A NON-CEMENTED IMPLANT TO REPLACE A PAINFUL ARTHRITIC ANKLE JOINT DUE TO OSTEOARTHRITIS, POST-TRAUMATIC ARTHRITIS OR RHEUMATOID ARTHRITIS.
Approval OrderApproval Order
SummarySummary of Safety and Effectiveness
LabelingLabeling
Post-Approval StudyShow Report Schedule and Study Progress
Supplements:  S001 S002 S004 S005 S006 S007 S008 S010 S011 S012 S014 
S015 S016 S017 S018 S019 S020 S021 S022 S023 S024 S025 S026 
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