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U.S. Department of Health and Human Services

Premarket Approval (PMA)
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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.
 
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
Supplement NumberS024
Date Received08/16/2022
Decision Date11/13/2023
Product Code NTG 
Advisory Committee Orthopedic
Supplement TypeNormal 180 Day Track
Supplement Reason Change Design/Components/Specifications/Material
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
approval for changing the mobile bearing component material of the Scandinavian Total Ankle Replacement System (S.T.A.R.) from ultra-high molecular weight polyethylene to moderately crosslinked Vitamin E blended ultra-high molecular weight polyethylene.
Post-Approval StudyShow Report Schedule and Study Progress
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