510(k) Report

Devices descending from K013035

9 later devices reach Guardian Limb Salvage System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K240043EVOLUTION® Hinge Knee System;GUARDIAN™ limb Salvage System;DCW Modular Distal Femoral…Microport Orthopedics, Inc.20240—
+1K230563EVOLUTION® Hinge Knee SystemMicroport Orthopedics, Inc.20231—
+1K161520ELEOS Limb Salvage SystemOnkos Surgical, Inc.2016611
+2K253066ELEOS™ with NanoCept® Technology Limb Salvage SystemOnkos Surgical, Inc.20260—
+2K252920ELEOS™ Limb Salvage System with NanoCept® TechnologyOnkos Surgical, Inc.20250—
+2K211677ELEOS Limb Salvage SystemOnkos Surgical20210—
+2K203815ELEOS Limb Salvage System with BioGripOnkos Surgical202103
+2K203588ELEOS™ Limb Salvage SystemOnkos Surgical202103
+2K203090ELEOS Limb Salvage System featuring BIOGRIPOnkos Surgical20201—