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Device | Scandinavian Total Ankle Replacement System (S.T.A.R. Ankle) |
Generic Name | Prosthesis, ankle, uncemented, non-constrained |
Applicant | DJO Global 9800 Metric Boulevard Austin, TX 78758 |
PMA Number | P050050 |
Supplement Number | S024 |
Date Received | 08/16/2022 |
Decision Date | 11/13/2023 |
Product Code |
NTG |
Advisory Committee |
Orthopedic |
Supplement Type | Normal 180 Day Track |
Supplement Reason | Change Design/Components/Specifications/Material |
Expedited Review Granted? | No |
Combination Product | No |
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 Study | Show Report Schedule and Study Progress |