510(k) Report

Devices descending from K160461

3 later devices reach Arthrex iBalance BiCompartmental Arthroplasty System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K200433iBalance UKA Tibial Tray ImplantArthrex, Inc.20201—
+1K171365Arthrex Knee SystemsArthrex, Inc.20170—
+2K251453Arthrex iBalance Partial Knee SystemArthrex, Inc.20250—