510(k) Report

Devices descending from K935080

5 later devices reach Insall-Burstein II through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K240043EVOLUTION® Hinge Knee System;GUARDIAN™ limb Salvage System;DCW Modular Distal Femoral…Microport Orthopedics, Inc.20240—
+1K140222Saiph Knee SystemMatortho20140—
+1K120038A200 Knee SystemRenovis Surgical Technologies, LLC20132—
+2K243295Initia Knee SystemKyocera Medical Technologies, Inc.20250—
+2K190122Renovis A200 PS Knee System as part of the Renovis A200 Knee SystemRenovis Surgical Technologies20191—