SCANDINAVIAN TOTAL ANKLE REPLACEMENT SYSTEM (S.T.A.R.ANKLE)

Prosthesis, Ankle, Uncemented, Non-constrained

FDA Premarket Approval P050050

This medical device has supplements. The device description/function or indication may have changed. Be sure to look at the supplements to get an up-to-date information on device changes. The labeling included below is the version at time of approval of the original pma or panel track supplement and may not represent the most recent labeling.

Pre-market Approval Supplement Details

Approval for the star ankle. The device is indicated for use as a non-cemented implant to replace a painful arthritic ankle joint due to osteoarthritis, post-traumatic arthritis or rheumatoid arthritis.

DeviceSCANDINAVIAN TOTAL ANKLE REPLACEMENT SYSTEM (S.T.A.R.ANKLE)
Classification NameProsthesis, Ankle, Uncemented, Non-constrained
Generic NameProsthesis, Ankle, Uncemented, Non-constrained
ApplicantSTRYKER CORPORATION
Date Received2005-12-07
Decision Date2009-05-27
Notice Date2011-05-10
PMAP050050
SupplementS
Product CodeNTG
Docket Number11M-0323
Advisory CommitteeOrthopedic
Expedited ReviewYes
Combination Product No
Applicant Address STRYKER CORPORATION bohnackerweg 1 selzach CH 25
Summary:Summary of Safety and Effectiveness
Labeling: Labeling
Post-Approval Study:Show Report Schedule and Study Progress
Approval Order: Approval Order

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
00850062461369 P050050 000
00810028394971 P050050 023
00810028393431 P050050 023
00810028393448 P050050 023
00810028393455 P050050 023
00810028393462 P050050 023
00810028393486 P050050 024
00810028393493 P050050 024
00810028393509 P050050 024
00810028393516 P050050 024
00810028393523 P050050 024
00810028393530 P050050 024
00810028393547 P050050 024
00810028393554 P050050 024
00810028393479 P050050 024

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