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U.S. Department of Health and Human Services

Premarket Approval (PMA)

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Note: 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.
 
DeviceSCANDINAVIAN TOTAL ANKLE REPLACEMENT SYSTEM (S.T.A.R.ANKLE)
Classification Nameprosthesis, ankle, uncemented, non-constrained
Generic Nameprosthesis, ankle, uncemented, non-constrained
Applicant
STRYKER CORPORATION
bohnackerweg 1
selzach CH 25
PMA NumberP050050
Date Received12/07/2005
Decision Date05/27/2009
Product Code
NTG[ Registered Establishments with NTG ]
Docket Number 11M-0323
Notice Date 05/10/2011
Advisory Committee Orthopedic
Expedited Review Granted? Yes
Combination Product No
Approval Order Statement 
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.
Approval Order Approval Order
Summary Summary of Safety and Effectiveness
Labeling Labeling
Post-Approval StudyShow Report Schedule and Study Progress
Supplements: S001 S002 S004 S005 S006 S007 S008 S010 
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