510(k) Report

Devices descending from K123457

4 later devices reach Balanced Knee System High Flex PS through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K253161Balanced Knee System TriMax Porous Femoral ComponentsOrtho Development Corp.20250—
+1K152169Balanced Knee System TriMax CR Femoral Component and E-Vitalize CR and UC Tibial InsertsOrtho Development Corporation20151—
+1K131337Balanced Knee System High Flex Vitamin E PS Tibial Insert and PatellaOrtho Development Corp.20133—
+2K233093Balanced Knee® System TriMax PS Plus Tibial InsertOrtho Development Corporation20230—