Scandinavian Total Ankle Replacement (S.T.A.R. Ankle)

FDA Premarket Approval P050050 S020

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.

Pre-market Approval Supplement Details

Approval for addition of a symbol to the package labels of star stainless steel instruments.

DeviceScandinavian Total Ankle Replacement (S.T.A.R. Ankle)
Generic NameProsthesis, Ankle, Uncemented, Non-constrained
ApplicantDJO Global
Date Received2021-11-19
Decision Date2021-12-17
PMAP050050
SupplementS020
Product CodeNTG 
Advisory CommitteeOrthopedic
Supplement TypeSpecial (immediate Track)
Supplement ReasonLabeling Change - Indications/instructions/shelf Life/tradename
Expedited ReviewNo
Combination Product No
Applicant Address DJO Global 9800 Metric Boulevard austin, TX 78758

Supplemental Filings

Supplement NumberDateSupplement Type
P050050Original Filing
S020 2021-11-19 Special (immediate Track)
S019 2021-07-09 Normal 180 Day Track No User Fee
S018 2021-03-24 30-day Notice
S017 2021-02-16 30-day Notice
S016 2020-12-14 30-day Notice
S015 2020-11-02 30-day Notice
S014 2020-08-03 30-day Notice
S013
S012 2018-08-21 Real-time Process
S011 2017-10-10 Real-time Process
S010 2016-07-12 Real-time Process
S009
S008 2016-04-11 Normal 180 Day Track No User Fee
S007 2014-03-11 Normal 180 Day Track No User Fee
S006 2014-03-10 Real-time Process
S005 2012-11-13 Special (immediate Track)
S004 2012-09-04 Normal 180 Day Track No User Fee
S003
S002 2009-08-21 Normal 180 Day Track No User Fee
S001 2009-08-05 Normal 180 Day Track No User Fee

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