Scandinavian Total Ankle Replacement (STAR Ankle)

FDA Premarket Approval P050050 S015

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 modification to the gamma sterilization load configuration, positioning in the sterilization chamber and subsequent dose map validation.

DeviceScandinavian Total Ankle Replacement (STAR Ankle)
Generic NameProsthesis, Ankle, Uncemented, Non-constrained
ApplicantSTRYKER CORPORATION
Date Received2020-11-02
Decision Date2020-12-01
PMAP050050
SupplementS015
Product CodeNTG 
Advisory CommitteeOrthopedic
Supplement Type30-day Notice
Supplement ReasonProcess Change - Manufacturer/sterilizer/packager/supplier
Expedited ReviewNo
Combination Product No
Applicant Address STRYKER CORPORATION bohnackerweg 1 selzach CH 25

Supplemental Filings

Supplement NumberDateSupplement Type
P050050Original Filing
S025 2022-09-02 30-day Notice
S024
S023
S022 2022-02-01 30-day Notice
S021
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

NIH GUDID Devices

Device IDPMASupp
00810028394971 P050050 023
00810028393462 P050050 023
00810028393455 P050050 023
00810028393448 P050050 023
00810028393431 P050050 023

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.