510(k) Report

Devices descending from K853661

7 later devices reach Millar/Galante Precoated Total Knee through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K071499Columbus Total Knee System Mios CR/PS Tibial TrayAesculap Implant Systems, Inc.20076—
+2K143443VEGA Knee System, Columbus Total Knee SystemAesculap Implants Systems, LLC20153—
+2K081293Univation Unicondylar Knee SystemAesculap Implant Systems, Inc.200818
+3K191765OMNI TiN Coated Apex Knee™ SystemOmni Life Science, Inc.20192—
+3K131167UnivationAesculap Implant Systems, LLC201308
+4K252044Triathlon® Total Knee System - Triathlon® Gold Femoral ComponentsHowmedica Osteonics Corp., Dba Stryker Orthopaedics20250—
+4K201611Apex Knee SystemOmnilife Science20210—