510(k) Report

Devices descending from K131337

3 later devices reach Balanced Knee System High Flex Vitamin E PS Tibial Insert and Patella through their predicates, nearest generation first.

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