510(k) Report

Devices descending from K101815

10 later devices reach Enduro Knee System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K191765OMNI TiN Coated Apex Knee™ SystemOmni Life Science, Inc.20192—
+1K130299GMK HingeMedacta International201342
+1K120955Columbus Total Knee System as Columbus Revision Knee System Enduro Knee SystemAesculap Implant Systems, LLC20124—
+2K252044Triathlon® Total Knee System - Triathlon® Gold Femoral ComponentsHowmedica Osteonics Corp., Dba Stryker Orthopaedics20250—
+2K201611Apex Knee SystemOmnilife Science20210—
+2K210010GMK Revision & Hinge Extension - TiNbN CoatingMedacta International S.A.20211—
+2K172347GMK Hinge, GMK RevisionMedacta International S.A.20172—
+2K163311GMK Revision Femoral Distal AugmentationMedacta International S.A.20162—
+2K143443VEGA Knee System, Columbus Total Knee SystemAesculap Implants Systems, LLC20153—
+3K211664GMK Sphere RevisionMedacta International S.A.20210—