510(k) Report

Devices descending from K013340

20 later devices reach RT-Plus Knee Additional Components through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K023667RT-Plus Solution & RT-Plus Modular Solution KneePlus Orthopedics200219—
+2K081111Legion Hinge Knee SystemSmith & Nephew, Inc.2008117
+2K053390Columbus (CR) Total Knee SystemAesculap, Inc.200651
+2K032215VKS/TC-Plus Revision KneePlus Orthopedics20036—
+3K230653Smith & Nephew, Inc. ANTHEM Total Knee System, Genesis Uni Knee System, JOURNEY BCS and…Smith & Nephew, Inc.202331
+3K151118Smith and Nephew Legion Hinge Knee SystemSmith & Nephew20154—
+3K143443VEGA Knee System, Columbus Total Knee SystemAesculap Implants Systems, LLC20153—
+3K120955Columbus Total Knee System as Columbus Revision Knee System Enduro Knee SystemAesculap Implant Systems, LLC20124—
+3K121393Smith & Nephew, Inc. Total Knee System InstrumentationSmith & Nephew, Inc.201254
+4K261462LANDMARK Total Knee SystemSmith & Nephew, Inc.20260—
+4K241260ACTIFY™ Unicondylar Knee SystemGlobus Medical, Inc.20240—
+4K242711JOURNEY II Unicompartmental Knee System (JOURNEY II UK)Smith & Nephew, Inc.20240—
+4K191765OMNI TiN Coated Apex Knee™ SystemOmni Life Science, Inc.20192—
+4K173331JOURNEY II XR Knee InstrumentsSmith & Nephew, Inc.201714
+4K141585Smith & Nephew Disposable Fin PunchSmith & Nephew, Inc.20140—
+4K123159Smith & Newphew, Inc. Disposable Knee InstrumentsSmith & Nephew, Inc.20132—
+5K252044Triathlon® Total Knee System - Triathlon® Gold Femoral ComponentsHowmedica Osteonics Corp., Dba Stryker Orthopaedics20250—
+5K201611Apex Knee SystemOmnilife Science20210—
+5K200227Journey II XR Knee InstrumentSmith & Nephew, Inc.20200—
+5K143226Visionaire Disposable InstrumentsSmith & Nephew, Inc.20150—