510(k) Report

Devices descending from K945028

75 later devices reach Finn Knee System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K051570Avl Hinge Knee SystemBiomet, Inc.20054—
+1K041352Compress Distal Femoral Replacement SystemBiomet, Inc.200412—
+1K031804Compress Distal Femoral ReplacementBiomet, Inc.200313—
+1K020381Expandable KneeBiomet Orthopedics, Inc.200232
+1K013385Nexgen Complete Knee Solution Rotatng Hinge KneeZimmer, Inc.2002542
+2K190100USTAR II SystemUnited Orthopedic Corporation201925
+2K173057Zimmer Knee Joint Replacement Prostheses MR LabelingZimmer, Inc.201852
+2K152494Zimmer NexGen Complete Knee Solution Tibial and Femoral AugmentsZimmer, Inc.201561
+2K143179The LINK® Endo-Model® Knee SystemWaldemar Link GmbH & Co. KG2015117
+2K140509Biomet Side Access Distal Femoral ExpandableBiomet Manufacturing, LLC20141—
+2K130299GMK HingeMedacta International201342
+2K122015Distal Femoral Growing Prosthesis, Tibial Rotating Components, Bearing, Axis, Circlip…Howmedica Osteonics Corp.20130—
+2K120992Mets Smiles Total Knee ReplacementStanmore Implants Worldwide, Ltd.201236
+2K110940Zimmer Segment System Trabecular Metal Proximal Tibial Component, Trabecular Metal…Zimmer, Inc.201110—
+2K101815Enduro Knee SystemAesculap Implant Systems201010—
+2K081111Legion Hinge Knee SystemSmith & Nephew, Inc.2008117
+2K070978Zimmer Segmental SystemZimmer, Inc.2007136
+2K043547Compress Segmental Femoral Replacement SystemBiomet, Inc.2005116
+3K252303Stem Extension Line (USTAR II System)United Orthopedic Corporation20250—
+3K243656U2 Total Knee System – PF+ Patella; USTAR II System– PF+ PatellaUnited Orthopedic Corporation20250—
+3K241059Pantheon Proximal Femur Reconstruction (PFR) SystemAdler Ortho S.P.A20250—
+3K230653Smith & Nephew, Inc. ANTHEM Total Knee System, Genesis Uni Knee System, JOURNEY BCS and…Smith & Nephew, Inc.202331
+3K220628LINK Endo-Model EVO Knee SystemWaldemar Link GmbH & Co. KG20220—
+3K211768LINK Endo-Model Knee System, Femoral Segments (Augments), UHMWPEWaldemar Link GmbH & Co. KG20210—
+3K202924LinkSymphoKnee SystemWaldemar Link GmbH & Co. KG2021211
+3K210010GMK Revision & Hinge Extension - TiNbN CoatingMedacta International S.A.20211—
+3K192798Zimmer Segmental SystemZimmer, Inc.20200—
+3K190181Instruments for LINK MEGASYSTEM-C FamilyLinkBio Corp.20190—
+3K191765OMNI TiN Coated Apex Knee™ SystemOmni Life Science, Inc.20192—
+3K191625Persona Revision Knee SystemZimmer, Inc.201911
+3K183136Zimmer Segmental System Proximal Femoral ComponentZimmer, Inc.20191—
+3K181947Persona Revision Knee SystemZimmer, Inc.201841
+3K172347GMK Hinge, GMK RevisionMedacta International S.A.20172—
+3K163311GMK Revision Femoral Distal AugmentationMedacta International S.A.20162—
+3K152431LINK Endo-Model Knee System with PorEx (TiNbN) coating, Link Sled Knee System with PorEx…Waldemar Link GmbH & Co. KG2016916
+3K152621OSS/Arcos IM Total Femur RodBiomet, Inc.20150—
+3K151118Smith and Nephew Legion Hinge Knee SystemSmith & Nephew20154—
+3K140900Patient Specific Smiles Total Knee ReplacementStanmore Worldwide Implants, Ltd.20150—
+3K150028Zimmer Segmental System XT ComponentsZimmer, Inc.20151—
+3K141331Biomet Orthopaedic Salvage System (Oss)Biomet, Inc.20143—
+3K133152JTS Extendible Distal Femoral ImplantStanmore Implants Worldwide, Ltd.201421
+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
+3K101475Compress Anti-Rotation SpindlesBiomet Manufacturing Corp20101—
+3K081860Zimmer Segmental System Variable Stiffness Stem Extensions and Intercalary SegmentsZimmer, Inc.200811
+3K080330Segmental Distal Femoral Components and Proximal Femoral Bodies with a Compress Female…Biomet, Inc.20082—
+3K062998Compress Segmental Femoral Replacement System (Short Spindle and Anchor Plug)Biomet Manufacturing Corp20071021
+4K261462LANDMARK Total Knee SystemSmith & Nephew, Inc.20260—
+4K253515Zimmer Biomet OSS™ Orthopedic Salvage System OsseoTi® Sleeves and AugmentsBiomet Orthopedics, Inc.20260—
+4K252044Triathlon® Total Knee System - Triathlon® Gold Femoral ComponentsHowmedica Osteonics Corp., Dba Stryker Orthopaedics20250—
+4K243724Persona® Revision Knee System (Persona Revision SoluTion™ Femoral Components)Zimmer, Inc.20250—
+4K241260ACTIFY™ Unicondylar Knee SystemGlobus Medical, Inc.20240—
+4K242711JOURNEY II Unicompartmental Knee System (JOURNEY II UK)Smith & Nephew, Inc.20240—
+4K230471LinkSymphoKnee – Fixed Bearing Ultracongruent (FB UC) Articulating SurfaceWaldemar Link GmbH & Co. KG20230—
+4K212742GEMINI SL Total Knee System, Endo-Model Knee System, and Sled Knee System with LINK…Waldemar Link GmbH & Co. KG2021122
+4K211664GMK Sphere RevisionMedacta International S.A.20210—
+4K210829Persona Revision Knee System Femoral Metaphyseal ConesZimmer, Inc.20210—
+4K201611Apex Knee SystemOmnilife Science20210—
+4K210551Persona Revision Knee SystemZimmer, Inc.202101
+4K202684GMK Total Knee System - TiNbN CoatingMedacta International S.A.20203—
+4K183553Compress and Mini Compress Anti-Rotation SpindlesBiomet, Inc.20190—
+4K173331JOURNEY II XR Knee InstrumentsSmith & Nephew, Inc.201714
+4K142814Biomet Orthopaedic Salvage System (OSSTM) - Proximal Femoral & Hybrid TibialBiomet Manufacturing, LLC201516
+4K143443VEGA Knee System, Columbus Total Knee SystemAesculap Implants Systems, LLC20153—
+4K140898Patient Specific Distal FemoralStanmore Implants Worldwide, Ltd.201502
+4K141585Smith & Nephew Disposable Fin PunchSmith & Nephew, Inc.20140—
+4K123159Smith & Newphew, Inc. Disposable Knee InstrumentsSmith & Nephew, Inc.20132—
+4K112905Compress (R) Segmental Humeral Replacement SystemBiomet Orthopedics, LLC201252
+5K203755Shoulder System - TiNbN CoatingMedacta International S.A.20210—
+5K200227Journey II XR Knee InstrumentSmith & Nephew, Inc.20200—
+5K173411Comprehensive Segmental Revision System (SRS)Biomet Manufacturing Corp20182—
+5K143226Visionaire Disposable InstrumentsSmith & Nephew, Inc.20150—
+5K123297Compress Segmental Humeral Replacement SystemBiomet Manufactuting Corp.20121—
+6K223631Comprehensive Segmental Revision System (SRS)Biomet Orthopedics20231—
+7K251686Tornier Humeral Reconstruction System Max (Tornier HRS Max)Tornier, Inc.202501