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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Prosthesis, Knee, Femorotibial, Non-Constrained, Cemented, Metal/Polymer
510(k) Number K161060
Device Name Arthrex iBalance UKA System Vitamin E Tibial Bearing
Applicant
Arthrex, Inc.
1370 Creekside Blvd.
Naples,  FL  34108
Applicant Contact David L Rogers
Correspondent
Arthrex, Inc.
1370 Creekside Blvd.
Naples,  FL  34108
Correspondent Contact David L Rogers
Regulation Number888.3520
Classification Product Code
HSX  
Subsequent Product Code
OIY  
Date Received04/15/2016
Decision Date 12/15/2016
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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