510(k) Report

Devices descending from K010612

838 later devices reach Vectorvision Knee through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K021306Vectorvision CT-Free KneeBrainlab AG2002387—
+1K020631IPLANBrainlab AG2002343—
+1K021327Orthopilot Hto ModuleAesculap, Inc.20020—
+1K014113EndomapSiemens Medical Solutions USA, Inc.2002139—
+1K013569Orthopilot 2Aesculap, Inc.2002153—
+2K073615Brainlab Knee Essential, Brainlab Knee Unlimited CI Knee, CI Knee UnlimitedBrainlab AG200852—
+2K080678Uni-Knee 2.0Brainlab AG20081—
+2K080547Orthopilot Next Generation, Model FS101-FS106Aesculap Implant System, Inc.200822—
+2K072899Orthopilot 2 Total Hip Arthroplasty (Tha) Version 3.0Aesculap Implant Systems, Inc.20080—
+2K061362Pigalileo Total Knee Replacement (TKR) SystemPlus Orthopedics AG2006126—
+2K052966CI Knee, CI MI TKRBrainlab AG200654—
+2K031196Surgetics Ortho Kneelogics Navigation SystemPraxim2005149—
+2K042543Iplan! Digital TemplatingBrainlab AG20057—
+2K050752Aesculap Orthopilot 2 Tha V 2.0Aesculap, Inc.200583—
+2K050751Impax Orthopaedic Workstation, Model Impax ES 5.XAgfa Corp.20051353
+2K042513Vectorvision OsteotomyBrainlab AG200513—
+2K042512Vectorvision AclBrainlab AG200557—
+2K041703IPLAN!Brainlab AG200456—
+2K041899Vectorvision Uni-KneeBrainlab AG2004133—
+2K041330Iplan! FlowBrainlab AG20042—
+2K040368Vectorvision Hip 3.0Brainlab AG2004180—
+2K040344Impax OT3000 Orthopedic WorkstationAgfa Corp.20042—
+2K040050Instatrak System with Multiple Dataset Navigation, Model IT3500Ge Medical Systems Navigation and Visualization IN2004280Class I
+2K032511Intuition ImageBrainlab AG200435—
+2K033413Spineassist DeviceMazor Surgical Technologies, Ltd.200435—
+2K031770CI TKR/UkrBrainlab AG2003134—
+3K220652Knee 3Brainlab AG20220—
+3K111843Acufex Director Application Anatomic Guide SystemSmith & Nephew Inc., Endoscopy Div.20110—
+3K102251Dash KneeBrainlab AG201110—
+3K102990Brainlab KneeBrainlab AG201171
+3K093206Orthomap 3D 1.1 ModuleStryker Corp.20100—
+3K093118Brainlab Knee ArthroscopyBrainlab AG20100—
+3K093998Kneealign System with Reference SensorOrthalign, Inc.201040—
+3K093425Mako Surgical Corp Robotic Arm Interactive Orthopedic System-ThaMako Surgical Corp.2010112
+3K092619Etrax Needle System, Etrax Variable Angle Needle Guidance System, Virtutrax Universal…Civco20096117
+3K091000KneekgEmovi20090—
+3K091998Robotic Arm Interactive Orthopedic System-HipMako Surgical Corp.200912—
+3K091411Kneealign SystemOrthalign, Inc.200941—
+3K090375Orthopilot Next Generation-Uka Software, Model FS210Aesculap Implant System, Inc.200921—
+3K083644Mako Surgical Tactile Guidance System-HipMako Surgical Corp.200913—
+3K083483Brainlab Hip Unlimited, CI Hip UnlimitedBrainlab AG200970—
+3K083872Imns Medacta Navigation SystemMedacta International S.A.200914—
+3K082267Pigalileo Cas, Version 4.0 and TKR Base, Version 2.1Smith & Nephew, Inc.20081—
+3K081386Model 6150 (MYLAB70) and Model 6100 (MYLAB90)Esaote, S.p.A.2008532
+3K081232Total Knee Surgetics Navigation System with PraxitelesPraxim200818—
+3K080875Pigalileo 4TH Generation SystemSmith & Nephew, Inc.200879—
+3K080886Iplan RT ImageBrainlab AG200833—
+3K073467Spineassist SystemMazor Surgical Technologies, Ltd.200832—
+3K080608Digital LightboxBrainlab AG20086—
+3K072806Mako Surgical Tactile Guidance System (TGS)Mako Surgical Corp.2008781
+3K072716Vector Vision HipBrainlab AG200784—
+3K072573Vectorvision Hip and Hip SRBrainlab AG20070—
+3K063607Spineassist SystemMazor Surgical Technologies, Ltd.200733—
+3K070731Pigalileo Total Hip Replacement (THR) SystemPlus Orthopedics AG200781—
+3K071972Orthopedic Software for Impax WorkstationsAgfa Healthcare Corp.2007133—
+3K071297Impax SE Sigmacom Client (Pacs Workstation)Agfa Healthcare Corp.200701
+3K063028Vectorvision Hip SRBrainlab AG200611—
+3K062146Uni Knee Surgetics Navigation SystemPraxim S.A200699—
+3K060727Vectorvision HipBrainlab AG200671—
+3K053610AbarisTraxtal Technologies, Inc.20062783
+3K053542Surgetics Ortho Osteologics Navigation SystemPraxim S.A20060—
+3K060282Total Knee Surgetics Navigation SystemPraxim S.A2006147—
+3K053164Iplan FlowBrainlab AG20061—
+3K060121Biomet Pre-Calibrated Computer Aided Surgery Navigation Instruments for Hip ApplicationsBiomet Manufacturing Corp20060—
+3K060468Vectorvision HipBrainlab AG2006154—
+3K053127IPLANBrainlab AG200654—
+3K052213Navigation SW Hip 3.1 on CIBrainlab AG2005170—
+3K052178Depuy Cas Hip InstrumentationDePuy Orthopaedics, Inc.20052—
+3K052220Iplan RT FibertrackingBrainlab AG200534—
+3K051676Spineassist Device with Additional AccessoriesMazor Surgical Technologies, Ltd.200534—
+3K042867Philips Orthopaedic ApplicationsPhilips Medical Systems North America, Inc.20041—
+4K201435Molecular Flow SimulationsTherataxis, LLC20210—
+4K193559NextAR TKA PlatformMedacta Inernational SA202012—
+4K172462OrthAlign Plus SystemOrthalign, Inc.20178—
+4K153396Aesculap OrthoPilot Next GenerationAesculap Implant Systems, LLC20160—
+4K151414IQQA GuideEdda Technology20151—
+4K141694Aesculap Orthopilot Next GenerationAesculap Implant Systems, LLC201519—
+4K143396omni TRAX Active Patient TrackerCivco Medical Instruments CO Inc Dba Civco Medical Solutions20150—
+4K142944ArthroPlan Digital Templating SoftwareArthromeda, Inc.20140—
+4K141459Aplio 500/400/300 Diagnostic Ultrasound System, V5.0Toshibamedical Systems Corporation201439—
+4K142008Mylabseven, MylabalphaEsaote, S.p.A.2014193
+4K133901Pari-Path Surgical Navigation SystemParitic, Inc.20140—
+4K140434Medicad ClassicHectec GmbH20140—
+4K1339056200 / 6250 Ultrasound SystemEsaote, S.p.A.201434—
+4K131489Tractus Tissuemapper Image Recording System ApplicationTractus Corporation20132—
+4K121765Sculptor Robotic Guidance Arm (Rga)Stanmore Implants Worldwide, Ltd.20130—
+4K121498PercunavPhilips Health Care2012222—
+4K122011Navigation Software Hip-Universal; Navigation Software Hip THR-AesculapBrainlab AG201251
+4K111818Sonixgps Needle SensorUltrasonix Medical Corporation201215—
+4K121064Makoplasty Total Hip Application, Rio Standard SystemMako Surgical Corporation2012912
+4K120187Multi-Modality Image FusionIgt, LLC Dba Eigen20124—
+4K113680Soma Access Systems Exacttrack Procedure KitSoma Access Systems, LLC201101
+4K110021Dash HipBrainlab AG201147—
+4K111945Impax Next GenerationAgfa Healthcare N.V.201122
+4K110204Brainlab TraumaBrainlab AG201127—
+4K101627IPLANBrainlab AG201112—
+4K103829Kneealign SystemOrthalign, Inc.201139—
+4K103246Iplan RTBrainlab AG2011322
+4K101398Stereos WorkstationBiospace Med2011121
+4K1031526250 Ultrasound SytemsEsaote, S.p.A.201135—