510(k) Report

Devices descending from K083772

12 later devices reach Columbus Revision Knee System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K122985Columbus Revision Knee SystemAesculap Implant System, Inc.201201
+1K101815Enduro Knee SystemAesculap Implant Systems201010—
+2K191765OMNI TiN Coated Apex Knee™ SystemOmni Life Science, Inc.20192—
+2K130299GMK HingeMedacta International201342
+2K120955Columbus Total Knee System as Columbus Revision Knee System Enduro Knee SystemAesculap Implant Systems, LLC20124—
+3K252044Triathlon® Total Knee System - Triathlon® Gold Femoral ComponentsHowmedica Osteonics Corp., Dba Stryker Orthopaedics20250—
+3K201611Apex Knee SystemOmnilife Science20210—
+3K210010GMK Revision & Hinge Extension - TiNbN CoatingMedacta International S.A.20211—
+3K172347GMK Hinge, GMK RevisionMedacta International S.A.20172—
+3K163311GMK Revision Femoral Distal AugmentationMedacta International S.A.20162—
+3K143443VEGA Knee System, Columbus Total Knee SystemAesculap Implants Systems, LLC20153—
+4K211664GMK Sphere RevisionMedacta International S.A.20210—