510(k) Report

Devices descending from K013385

54 later devices reach Nexgen Complete Knee Solution Rotatng Hinge Knee through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K190100USTAR II SystemUnited Orthopedic Corporation201925
+1K173057Zimmer Knee Joint Replacement Prostheses MR LabelingZimmer, Inc.201852
+1K152494Zimmer NexGen Complete Knee Solution Tibial and Femoral AugmentsZimmer, Inc.201561
+1K143179The LINK® Endo-Model® Knee SystemWaldemar Link GmbH & Co. KG2015117
+1K130299GMK HingeMedacta International201342
+1K110940Zimmer Segment System Trabecular Metal Proximal Tibial Component, Trabecular Metal…Zimmer, Inc.201110—
+1K101815Enduro Knee SystemAesculap Implant Systems201010—
+1K081111Legion Hinge Knee SystemSmith & Nephew, Inc.2008117
+1K070978Zimmer Segmental SystemZimmer, Inc.2007136
+2K252303Stem Extension Line (USTAR II System)United Orthopedic Corporation20250—
+2K243656U2 Total Knee System – PF+ Patella; USTAR II System– PF+ PatellaUnited Orthopedic Corporation20250—
+2K241059Pantheon Proximal Femur Reconstruction (PFR) SystemAdler Ortho S.P.A20250—
+2K230653Smith & Nephew, Inc. ANTHEM Total Knee System, Genesis Uni Knee System, JOURNEY BCS and…Smith & Nephew, Inc.202331
+2K220628LINK Endo-Model EVO Knee SystemWaldemar Link GmbH & Co. KG20220—
+2K211768LINK Endo-Model Knee System, Femoral Segments (Augments), UHMWPEWaldemar Link GmbH & Co. KG20210—
+2K202924LinkSymphoKnee SystemWaldemar Link GmbH & Co. KG2021211
+2K210010GMK Revision & Hinge Extension - TiNbN CoatingMedacta International S.A.20211—
+2K192798Zimmer Segmental SystemZimmer, Inc.20200—
+2K190181Instruments for LINK MEGASYSTEM-C FamilyLinkBio Corp.20190—
+2K191765OMNI TiN Coated Apex Knee™ SystemOmni Life Science, Inc.20192—
+2K191625Persona Revision Knee SystemZimmer, Inc.201911
+2K183136Zimmer Segmental System Proximal Femoral ComponentZimmer, Inc.20191—
+2K181947Persona Revision Knee SystemZimmer, Inc.201841
+2K172347GMK Hinge, GMK RevisionMedacta International S.A.20172—
+2K163311GMK Revision Femoral Distal AugmentationMedacta International S.A.20162—
+2K152431LINK Endo-Model Knee System with PorEx (TiNbN) coating, Link Sled Knee System with PorEx…Waldemar Link GmbH & Co. KG2016916
+2K151118Smith and Nephew Legion Hinge Knee SystemSmith & Nephew20154—
+2K150028Zimmer Segmental System XT ComponentsZimmer, Inc.20151—
+2K141331Biomet Orthopaedic Salvage System (Oss)Biomet, Inc.20143—
+2K120955Columbus Total Knee System as Columbus Revision Knee System Enduro Knee SystemAesculap Implant Systems, LLC20124—
+2K121393Smith & Nephew, Inc. Total Knee System InstrumentationSmith & Nephew, Inc.201254
+2K081860Zimmer Segmental System Variable Stiffness Stem Extensions and Intercalary SegmentsZimmer, Inc.200811
+3K261462LANDMARK Total Knee SystemSmith & Nephew, Inc.20260—
+3K253515Zimmer Biomet OSS™ Orthopedic Salvage System OsseoTi® Sleeves and AugmentsBiomet Orthopedics, Inc.20260—
+3K252044Triathlon® Total Knee System - Triathlon® Gold Femoral ComponentsHowmedica Osteonics Corp., Dba Stryker Orthopaedics20250—
+3K243724Persona® Revision Knee System (Persona Revision SoluTion™ Femoral Components)Zimmer, Inc.20250—
+3K241260ACTIFY™ Unicondylar Knee SystemGlobus Medical, Inc.20240—
+3K242711JOURNEY II Unicompartmental Knee System (JOURNEY II UK)Smith & Nephew, Inc.20240—
+3K230471LinkSymphoKnee – Fixed Bearing Ultracongruent (FB UC) Articulating SurfaceWaldemar Link GmbH & Co. KG20230—
+3K212742GEMINI SL Total Knee System, Endo-Model Knee System, and Sled Knee System with LINK…Waldemar Link GmbH & Co. KG2021122
+3K211664GMK Sphere RevisionMedacta International S.A.20210—
+3K210829Persona Revision Knee System Femoral Metaphyseal ConesZimmer, Inc.20210—
+3K201611Apex Knee SystemOmnilife Science20210—
+3K210551Persona Revision Knee SystemZimmer, Inc.202101
+3K202684GMK Total Knee System - TiNbN CoatingMedacta International S.A.20203—
+3K173331JOURNEY II XR Knee InstrumentsSmith & Nephew, Inc.201714
+3K152621OSS/Arcos IM Total Femur RodBiomet, Inc.20150—
+3K142814Biomet Orthopaedic Salvage System (OSSTM) - Proximal Femoral & Hybrid TibialBiomet Manufacturing, LLC201516
+3K143443VEGA Knee System, Columbus Total Knee SystemAesculap Implants Systems, LLC20153—
+3K141585Smith & Nephew Disposable Fin PunchSmith & Nephew, Inc.20140—
+3K123159Smith & Newphew, Inc. Disposable Knee InstrumentsSmith & Nephew, Inc.20132—
+4K203755Shoulder System - TiNbN CoatingMedacta International S.A.20210—
+4K200227Journey II XR Knee InstrumentSmith & Nephew, Inc.20200—
+4K143226Visionaire Disposable InstrumentsSmith & Nephew, Inc.20150—