510(k) Report

Devices descending from K041106

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

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K230653Smith & Nephew, Inc. ANTHEM Total Knee System, Genesis Uni Knee System, JOURNEY BCS and…Smith & Nephew, Inc.202331
+1K202924LinkSymphoKnee SystemWaldemar Link GmbH & Co. KG2021211
+1K121393Smith & Nephew, Inc. Total Knee System InstrumentationSmith & Nephew, Inc.201254
+1K060742Legion Cobalt Chrome Revision Knee SystemSmith & Nephew, Inc.2006103
+1K043440Smith & Nephew, Inc. Revision Knee SystemSmith & Nephew, Inc.2005317
+2K261462LANDMARK Total Knee SystemSmith & Nephew, Inc.20260—
+2K241260ACTIFY™ Unicondylar Knee SystemGlobus Medical, Inc.20240—
+2K242711JOURNEY II Unicompartmental Knee System (JOURNEY II UK)Smith & Nephew, Inc.20240—
+2K230471LinkSymphoKnee – Fixed Bearing Ultracongruent (FB UC) Articulating SurfaceWaldemar Link GmbH & Co. KG20230—
+2K220628LINK Endo-Model EVO Knee SystemWaldemar Link GmbH & Co. KG20220—
+2K180334LEGION Knee SystemSmith & Nephew, Inc.20184—
+2K173331JOURNEY II XR Knee InstrumentsSmith & Nephew, Inc.201714
+2K151118Smith and Nephew Legion Hinge Knee SystemSmith & Nephew20154—
+2K141585Smith & Nephew Disposable Fin PunchSmith & Nephew, Inc.20140—
+2K123159Smith & Newphew, Inc. Disposable Knee InstrumentsSmith & Nephew, Inc.20132—
+2K103837Balanced Knee System Revision Offset TibiaOrtho Development20110—
+2K100370Symmetric Total Knee AgumentsSignal Medical Corp.20110—
+2K100981United Stem, Psa TypeUnited Orthopedic Corp.20103—
+2K053390Columbus (CR) Total Knee SystemAesculap, Inc.200651
+2K052265Smith & Nephew Competitor Duo Knee FemoralSmith & Nephew, Inc.2005242
+3K200227Journey II XR Knee InstrumentSmith & Nephew, Inc.20200—
+3K190100USTAR II SystemUnited Orthopedic Corporation201925
+3K143443VEGA Knee System, Columbus Total Knee SystemAesculap Implants Systems, LLC20153—
+3K143226Visionaire Disposable InstrumentsSmith & Nephew, Inc.20150—
+3K120955Columbus Total Knee System as Columbus Revision Knee System Enduro Knee SystemAesculap Implant Systems, LLC20124—
+3K061569Smith & Nephew Competitor Deuce Femoral ComponentsSmith & Nephew, Inc.20061—
+4K252303Stem Extension Line (USTAR II System)United Orthopedic Corporation20250—
+4K243656U2 Total Knee System – PF+ Patella; USTAR II System– PF+ PatellaUnited Orthopedic Corporation20250—
+4K191765OMNI TiN Coated Apex Knee™ SystemOmni Life Science, Inc.20192—
+4K113038Smith & Nephew Inc. Unicompartmental and Biocompartmental Knee System InstrumentsSmith & Nephew, Inc.20120—
+5K252044Triathlon® Total Knee System - Triathlon® Gold Femoral ComponentsHowmedica Osteonics Corp., Dba Stryker Orthopaedics20250—
+5K201611Apex Knee SystemOmnilife Science20210—