Premarket Approval (PMA)

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.

• Device: Scandinavian Total Ankle Replacement System (S.T.A.R. Ankle)
• Generic Name: Prosthesis, ankle, uncemented, non-constrained
• Applicant: Djo Global; 9800 Metric Blvd.; Austin, TX 78758
• PMA Number: P050050
• Supplement Number: S021
• Date Received: 01/25/2022
• Decision Date: 05/06/2022
• Product Code: NTG
• Advisory Committee: Orthopedic
• Supplement Type: Normal 180 Day Track No User Fee
• Supplement Reason: Postapproval Study Protocol
• Expedited Review Granted?: No
• Combination Product: No
• Predetermined Change Control Plan Authorized: No

Approval Order Statement  
Approval of the post approval study protocol referenced in the Actual Condition of Use Study (STAR 2).