Scandinavian Total Ankle Replacement (STAR Ankle)

FDA Premarket Approval P050050 S017

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

Change in sub-suppliers for the citric passivation steps for the star pin tube (727-0001-01) and the star pin tube cap (727-0001-02) components

DeviceScandinavian Total Ankle Replacement (STAR Ankle)
Generic NameProsthesis, Ankle, Uncemented, Non-constrained
Date Received2021-02-16
Decision Date2021-03-15
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
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
S012 2018-08-21 Real-time Process
S011 2017-10-10 Real-time Process
S010 2016-07-12 Real-time Process
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
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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