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.

• Device: SCANDINAVIAN TOTAL ANKLE REPLACEMENT SYSTEM (S.T.A.R.ANKLE)
• Classification Name: Prosthesis, Ankle, Uncemented, Non-constrained
• Generic Name: Prosthesis, Ankle, Uncemented, Non-constrained
• Applicant: STRYKER CORPORATION
• Date Received: 2005-12-07
• Decision Date: 2009-05-27
• Notice Date: 2011-05-10
• PMA: P050050
• Supplement: S
• Product Code: NTG
• Docket Number: 11M-0323
• Advisory Committee: Orthopedic
• Expedited Review: Yes
• 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 Number	Date	Supplement Type
P050050		Original 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 ID	PMA	Supp
00810028394971	P050050	023
00810028393462	P050050	023
00810028393455	P050050	023
00810028393448	P050050	023
00810028393431	P050050	023