FDA.reportPublic FDA data

PMA P050050S024

Device
Scandinavian Total Ankle Replacement System (S.T.A.R. Ankle)
Applicant
Djo Global
Product code
NTG
Decision date
2023-11-13
Generic name
Prosthesis, ankle, uncemented, non-constrained
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.

Current openFDA PMA Record#

Device
Scandinavian Total Ankle Replacement System (S.T.A.R. Ankle)
Applicant
Djo Global
PMA number
P050050
Supplement
S024
Product code
NTG
Generic name
Prosthesis, ankle, uncemented, non-constrained
Decision date
2023-11-13
Decision code
APPR
Date received
2022-08-16
Supplement type
Normal 180 Day Track
Supplement reason
Change Design/Components/Specifications/Material
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.