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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 Replacment (STAR Ankle)
Generic NameProsthesis, ankle, uncemented, non-constrained
ApplicantDjo Global
9800 Metric Blvd.
Austin, TX 78758
PMA NumberP050050
Supplement NumberS016
Date Received12/14/2020
Decision Date01/13/2021
Product Code NTG 
Advisory Committee Orthopedic
Supplement Type30-Day Notice
Supplement Reason Process Change - Manufacturer/Sterilizer/Packager/Supplier
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
Replace a broken coordinate measuring machine (CMM) used in the production of the STAR Tibial, Talar, and UHMWPE Mobile Bearing (also referred to as the Sliding Cores) components with another CMM (Zeiss Contura CMM) at the Waldemar Link contract manufacturing facility in Germany.
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