510(k) Report

Devices descending from K021980

355 later devices reach Hip Module for the Stealthstation System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K060727Vectorvision HipBrainlab AG200671—
+1K053610AbarisTraxtal Technologies, Inc.20062783
+1K052623Imageless Hip Module for the Stealthstation SystemMedtronic Navigation, Inc.200612—
+1K050651Medtronic Orthopaedic Trauma ApplicationMedtronic Navigation, Inc.20051—
+2K151414IQQA GuideEdda Technology20151—
+2K133759Intellijoint HipIntellijoint Surgical, Inc.201410—
+2K133901Pari-Path Surgical Navigation SystemParitic, Inc.20140—
+2K121498PercunavPhilips Health Care2012222—
+2K120187Multi-Modality Image FusionIgt, LLC Dba Eigen20124—
+2K093206Orthomap 3D 1.1 ModuleStryker Corp.20100—
+2K093672Aegis Navigation Anda Egis Pelvic ApplicationSentinelle Medical, Inc.20098—
+2K092619Etrax Needle System, Etrax Variable Angle Needle Guidance System, Virtutrax Universal…Civco20096117
+2K083483Brainlab Hip Unlimited, CI Hip UnlimitedBrainlab AG200970—
+2K080624Navstationirad Emt, Version 1.1Cas Innovations AG200863—
+2K061248Axiem Imageless Hip Module for the Stealthstation SystemMedtronic Navigation, Inc.20060—
+3K182524GALILEO Spine Alignment Monitoring SystemMiRus, LLC20190—
+3K162314IMACTIS CT-Navigation systemImactis, Sas201804
+3K161109iSR'obot MRI-US FusionBiobot Surgical Pte., Ltd.20162—
+3K151364Intellijoint HIP (tm) SystemIntellijoint Surgical, Inc.20158—
+3K143396omni TRAX Active Patient TrackerCivco Medical Instruments CO Inc Dba Civco Medical Solutions20150—
+3K141459Aplio 500/400/300 Diagnostic Ultrasound System, V5.0Toshibamedical Systems Corporation201439—
+3K140033TARGET3D FusionConvergent Life Sciences, Inc.20140—
+3K132304Epiq Diagnostic Ultrasound SystemPhilips Ultrasound, Inc.201321136
+3K132087Percunav SystemPhilips Health Care20139—
+3K131489Tractus Tissuemapper Image Recording System ApplicationTractus Corporation20132—
+3K123901Tractus Tissuemapper Reviewer ApplicationTractus Corporation20132—
+3K122011Navigation Software Hip-Universal; Navigation Software Hip THR-AesculapBrainlab AG201251
+3K111818Sonixgps Needle SensorUltrasonix Medical Corporation201215—
+3K113680Soma Access Systems Exacttrack Procedure KitSoma Access Systems, LLC201101
+3K110021Dash HipBrainlab AG201147—
+3K110204Brainlab TraumaBrainlab AG201127—
+3K093787Iguide CappaCas Innovations GmbH & Co. KG20100—
+4K221618Spine & Trauma Navigation, Spine Navigation, Navigation Software Spine & Trauma…Brainlab AG20226—
+4K213411iSR’obot Mona Lisa 2.0Biobot Surgical Pte., Ltd.20211—
+4K193307HIP7Brainlab AG20200—
+4K181449Ortoma Treatment Solution - OTSOrtoma AB20183—
+4K172849Intellijoint HIP System (Cart), Intellijoint HIP System (Portable), Intellijoint HIP…Intellijoint Surgical, Inc.201711
+4K171709BR-FHUS Viewer 1.0Taihao Medical, Inc.20171—
+4K171309BR-FHUS Navigation 1.0Taihao Medical, Inc.20171—
+4K171105AIXPLORER® & AIXPLORER® Ultimate Ultrasound SystemsSupersonic Imagine201719—
+4K170716PercuNav Image Fusion and Interventional NavigationPhilips Ultrasound, Inc.20173—
+4K162364Intellijoint HIP Generation 2A SystemIntellijoint Surgical, Inc.20177—
+4K163120EPIQ 5 Diagnostic Ultrasound System; EPIQ 7 Diagnostic Ultrasound System; Affiniti 50…Philips Ultrasound, Inc.20175828
+4K160807EPIQ 5 Diagnostic Ultrasound System, EPIQ 7Diagnostic Ultrasound System, Affiniti 50…Philips Ultrasound, Inc.201610033
+4K153004Clear Guide SCENERGYClear Guide Medical20164—
+4K153480ClearVue850 Diagnostic Ultrasound SystemPhilips Health Care2015210
+4K150773E-CUBE 15 Diagnostic Ultrasound SystemAlpinion Medical Systems Co., Ltd.201515—
+4K151451Aplio 500/400/300 Diagnostic Ultrasound System V6.0Toshibamedical Systems Corporation2015342
+4K150533Terason uSmart3200T Ultrasound SystemTeratech Corp.20152—
+4K150148Terason uSmart3300 Ultrasound SystemTeratech Corp.20150—
+4K142714S8 Exp/S9 Pro Portable Digital Color Doppler Ultrasound SystemSonoscape Company Limited20154—
+4K142815S22 Digital Color Doppler Ultrasound SystemSonoscape Company Limited20152—
+4K142710S9 Portable Digital Color Doppler Ultrasound SystemSonoscape Company Limited201519—
+4K142474S12 Digital Color Doppler Ultrasound SystemSonoscape Company Limited20144—
+4K140331Orthalign Plus SystemOrthalign, Inc.201429—
+4K140808Q-StationPhilips Ultrasound, Inc.201402
+4K140254EZONO 4000Ezono AG201413—
+4K133833Nuvis Diagnostic Ultrasound SystemPhilips Ultrasound, Inc.2014873
+4K130887S4C Navigation InstrumentsAesculap Implant System, Inc.201313—
+5K262257Spine Planning (3.0); Spine & Trauma Navigation; Alignment System SpineBrainlab SE20260—
+5K262253Lantern Knee Navigation Unit (406000-03);Lantern Hip Navigation Unit (502000-03)Orthalign, Inc.20260—
+5K260123EPIQ Series Diagnostic Ultrasound SystemPhilips Ultrasound, LLC202601
+5K252562Spine & Trauma Navigation InstrumentsBrainlab AG20250—
+5K242569Mixed Reality Spine NavigationBrainlab AG20250—
+5K241893CROSSNAV Navigation Enabled Instruments and UNAS Navigation ArraysMedos International SARL20241—
+5K240701Drill Guide; Drill Bit; Spine & Trauma NavigationBrainlab AG20240—
+5K232140OTS HipOrtoma AB202421
+5K232320iSR`obot Mona Lisa 2.0Biobot Surgical Pte., Ltd.20230—
+5K211098Breast Volume Navigator (BVN) Model G-2000Metritrack, Inc.20210—
+5K203751OMNIVision systemCorin USA20210—
+5K193094Naviswiss Hip Navigation SystemNaviswiss AG20201—
+5K192914Stimuplex Onvision SystemPhilips Medical Systems Nederland B.V.20200—
+5K201053PercuNav Image Fusion and Interventional NavigationPhilips Ultrasound, Inc.20201—
+5K193510Terason uSmart3200T Ultrasound SystemTeratech Corporation20201—
+5K190120Vinno 8, Vinno 6, Vinno 5Vinno Technology (Suzhou) Co.,Ltd20201—
+5K182594E-CUBE i7Alpinion Medical Systems Co., Ltd.20191—
+5K182894HM70A Diagnostic Ultrasound SystemSamsung Medison Co., Ltd.201910—
+5K181890Brainlab Compatible K2M Navigation InstrumentsK2m201811—
+5K181617E-CUBE 8Alpinion Medical Systems Co., Ltd.20180—
+5K181277E-CUBE 12Alpinion Medical Systems Co., Ltd.20187—
+5K180572AIXPLORER MACH Ultrasound Diagnostic Systems Aixplorer Mach 30, Aixplorer Mach 20…Supersonic Imagine201816—
+5K173021Aixplorer & Aixplorer Ultimate Ultrasound Diagnostic SystemsSupersonic Imagine201818—
+5K172732E-CUBE 8Alpinion Medical Systems Co., Ltd.201711—
+5K171677Clear Guide SCENERGYClear Guide Medical20173—
+5K171525Intellijoint HIP Generation 2B SystemIntellijoint Surgical, Inc.20173—
+5K171926C5 Diagnostic Ultrasound SystemGuangzhou Sonostar Technologies Co., Ltd.20171—
+5K172607Philips EPIQ 5 Diagnostic Ultrasound System, EPIQ 7 Diagnostic Ultrasound System…Philips Health Care20172831
+5K172055DUS-7000 Digital Color Doppler Ultrasound SystemAdvanced Instrumentations, Inc.20170—
+5K163702Aplio i900/i800/i700 Diagnostic Ultrasound System, V2.1Toshibamedical Systems Corporation2017221
+5K170078Medisono Color Doppler Ultrasound System, models P11 Portable, P11 EXPERT Portable, P12…Medisono, LLC20170—
+5K163690DC-70/DC-70T /DC-70 Pro/DC-70 Exp/DC-75/DC-78/DC-70S Diagnostic Ultrasound SystemShenzhen Mindray Bio-Medical Electronics Co., Ltd.20179—
+5K170277DC-8/DC-8 PRO/DC-8 CV/DC-8 EXP/DC-8S Diagnostic Ultrasound SystemShenzhen Mindray Bio-Medical Electronics Co., Ltd.201720—
+5K1630826200 Ultrasound System and 6250 Ultrasound SystemEsaote, S.p.A.201792
+5K163020Xperius Ultrasound SystemPhilips Health Care201611
+5K161439E-CUBE 11Alpinion Medical Systems Co., Ltd.201612—
+5K161843Aplio i900/i800/i700 Diagnostic Ultrasound System, V2.0Toshibamedical Systems Corporation2016231
+5K162329CX50 Diagnostic Ultrasound System, Sparq Diagnostic Ultrasound SystemPhilips Health Care2016273
+5K153700Aesculap (R) Implant Systems (AIS) S4 Navigation InstrumentsAesculap Implant Systems, LLC20160—
+5K153237OrthAlign Plus SystemOrthalign, Inc.201618—
+5K153424E-CUBE i7Alpinion Medical Systems Co., Ltd.201614—