510(k) Report

Devices descending from K014256

419 later devices reach Kolibri Igs Systems through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K122096Karl Storz Navigationpanel Unit (Npu) SystemKARL STORZ Endoscopy-America, Inc.20125—
+1K110021Dash HipBrainlab AG201147—
+1K102251Dash KneeBrainlab AG201110—
+1K052213Navigation SW Hip 3.1 on CIBrainlab AG2005170—
+1K042721Kolibri SpineBrainlab AG2005187—
+1K042391Kolibri Image Guided Surgery SystemBrainlab AG200472—
+1K031770CI TKR/UkrBrainlab AG2003134—
+2K213989Cranial EM SystemBrainlab AG20221—
+2K220652Knee 3Brainlab AG20220—
+2K172462OrthAlign Plus SystemOrthalign, Inc.20178—
+2K163439NaviENTClaronav, Inc.20171—
+2K161555KARL STORZ NAV1 Electromagnetic Navigation SystemKarl Storz Endoscopy America, Inc.20162—
+2K133759Intellijoint HipIntellijoint Surgical, Inc.201410—
+2K140331Orthalign Plus SystemOrthalign, Inc.201429—
+2K130887S4C Navigation InstrumentsAesculap Implant System, Inc.201313—
+2K122011Navigation Software Hip-Universal; Navigation Software Hip THR-AesculapBrainlab AG201251
+2K110204Brainlab TraumaBrainlab AG201127—
+2K093425Mako Surgical Corp Robotic Arm Interactive Orthopedic System-ThaMako Surgical Corp.2010112
+2K091998Robotic Arm Interactive Orthopedic System-HipMako Surgical Corp.200912—
+2K083644Mako Surgical Tactile Guidance System-HipMako Surgical Corp.200913—
+2K082060Cranial Image Guided Surgery SystemBrainlab AG200916—
+2K083483Brainlab Hip Unlimited, CI Hip UnlimitedBrainlab AG200970—
+2K081386Model 6150 (MYLAB70) and Model 6100 (MYLAB90)Esaote, S.p.A.2008532
+2K072716Vector Vision HipBrainlab AG200784—
+2K062086NavivisionBrainlab AG200677—
+2K053159Vectorvision SpineBrainlab AG20061551
+2K060121Biomet Pre-Calibrated Computer Aided Surgery Navigation Instruments for Hip ApplicationsBiomet Manufacturing Corp20060—
+2K060468Vectorvision HipBrainlab AG2006154—
+2K052966CI Knee, CI MI TKRBrainlab AG200654—
+2K041899Vectorvision Uni-KneeBrainlab AG2004133—
+3K262253Lantern Knee Navigation Unit (406000-03);Lantern Hip Navigation Unit (502000-03)Orthalign, Inc.20260—
+3K243053Navient Image Guided Navigation System (ENT) (955-NC-NC)Claronav20250—
+3K223288Cranial Navigation, Navigation Software Cranial, Navigation Software Craniofacial…Brainlab AG20230—
+3K221618Spine & Trauma Navigation, Spine Navigation, Navigation Software Spine & Trauma…Brainlab AG20226—
+3K203115ARVIS Surgical Navigation SystemInsight Medical Systems, Inc.202132
+3K201752Disposable Pre-calibrated SuctionBrainlab AG20210—
+3K200376Navbit Sprint System- Supine Registration, Navbit Sprint Kit - Lateral RegistrationNavbit Pty, Ltd.20201—
+3K201174TruDi CuretteAcclarent, Inc.20200—
+3K193307HIP7Brainlab AG20200—
+3K193580VERASENSE for Zimmer Biomet Persona CR C-D/3-9 Left, VERASENSE for Zimmer Biomet Persona…Orthosensor, Inc.20201—
+3K190250Microscope NavigationBrainlab AG20190—
+3K182524GALILEO Spine Alignment Monitoring SystemMiRus, LLC20190—
+3K181890Brainlab Compatible K2M Navigation InstrumentsK2m201811—
+3K181449Ortoma Treatment Solution - OTSOrtoma AB20183—
+3K180948TruDi NAV Suction InstrumentsAcclarent, Inc.201805
+3K172820Microscope Navigation SoftwareBrainlab AG20181—
+3K153700Aesculap (R) Implant Systems (AIS) S4 Navigation InstrumentsAesculap Implant Systems, LLC20160—
+3K153237OrthAlign Plus SystemOrthalign, Inc.201618—
+3K151364Intellijoint HIP (tm) SystemIntellijoint Surgical, Inc.20158—
+3K150741TSolution One w/ACG surgical SystemTHINK Surgical, Inc.20159—
+3K142008Mylabseven, MylabalphaEsaote, S.p.A.2014193
+3K1339056200 / 6250 Ultrasound SystemEsaote, S.p.A.201434—
+3K121765Sculptor Robotic Guidance Arm (Rga)Stanmore Implants Worldwide, Ltd.20130—
+3K121064Makoplasty Total Hip Application, Rio Standard SystemMako Surgical Corporation2012912
+3K1031526250 Ultrasound SytemsEsaote, S.p.A.201135—
+3K100038Disposable Reflective Marker SpheresBrainlab AG201023
+3K100931Mylabtwice, Model 6200Esaote, S.p.A.201046—
+3K092467Vectorvision Cranial, Vectorvision Ent, Kolibri Cranial, Kolibri Ent, Cranial Essential…Brainlab AG201010Class I
+3K091009MY LABS25 Gold/MYLAB30 Gold Cardiovascular Model 7340, MY LAB70/MY LAB70XVISION/MYLAB60…Esaote, S.p.A.200951—
+3K081509Monteris Medical Autolitt Laser ProbeMonteris Medical,200922—
+3K073615Brainlab Knee Essential, Brainlab Knee Unlimited CI Knee, CI Knee UnlimitedBrainlab AG200852—
+3K080678Uni-Knee 2.0Brainlab AG20081—
+3K072806Mako Surgical Tactile Guidance System (TGS)Mako Surgical Corp.2008781
+3K072267Total Hip Surgetics Navigation SystemPraxim S.A20070—
+3K070731Pigalileo Total Hip Replacement (THR) SystemPlus Orthopedics AG200781—
+3K070106VV Fluoro 3DBrainlab AG2007119Class I
+3K063408Ctlogics Navigations SystemsPraxim Medivision, SA200734—
+4K262257Spine Planning (3.0); Spine & Trauma Navigation; Alignment System SpineBrainlab SE20260—
+4K261410Navbit MARQ (PRD-001-SUP (Supine Registration Kit), PRD-001-LAT (Lateral Registration…Suite 201, National Innovation Centre20260—
+4K231897NeuroAlign softwareMedivis, Inc.20250—
+4K252562Spine & Trauma Navigation InstrumentsBrainlab AG20250—
+4K242569Mixed Reality Spine NavigationBrainlab AG20250—
+4K243980ARVIS Surgical Navigation SystemKico Knee Innovation Company Pty Limited202501
+4K241893CROSSNAV Navigation Enabled Instruments and UNAS Navigation ArraysMedos International SARL20241—
+4K240701Drill Guide; Drill Bit; Spine & Trauma NavigationBrainlab AG20240—
+4K240062ARVIS® ShoulderInsight Medical Systems, Inc.20241—
+4K232140OTS HipOrtoma AB202421
+4K220830TrueBalance™ Surgical SystemThese Three Medical, LLC20220—
+4K192703Cranial Image Guided Surgery System, Navigation Software Cranial, Navigation Software…Brainlab AG20203—
+4K201006K2M Navigation InstrumentsK2m, Inc.20200—
+4K192911Brainlab Compatible K2M Navigation InstrumentsK2m, Inc.20199—
+4K191285Spine & Trauma NavigationBrainlab AG20190—
+4K182036NeuroBlate SystemMonteris Medical,201811—
+4K172115Navigated Instrument SystemOrthofix, Inc.20184—
+4K172849Intellijoint HIP System (Cart), Intellijoint HIP System (Portable), Intellijoint HIP…Intellijoint Surgical, Inc.201711
+4K172881NeuroBlate SystemMonteris Medical,201713—
+4K171661Scopis Extended Instrument Set EMScopis GmbH20173—
+4K162567ExactechGPS Total Shoulder Application, Equinoxe Planning SoftwareBlue Ortho2017151
+4K162921Navigated Instrument SystemOrthofix, Inc.20175—
+4K162364Intellijoint HIP Generation 2A SystemIntellijoint Surgical, Inc.20177—
+4K163379KneeAlign 2 SystemOrthalign, Inc.20171—
+4K162962OrthAlign Plus SystemOrthalign, Inc.201715—
+4K161999AixplorerSupersonic Imagine201620—
+4K161168MyLabSix Ultrasound SystemEsaote Europe B.V.20161—
+4K1613596400 Ultrasound System,7400 Ultrasound System, 7410 Ultrasound SystemEsaote, S.p.A.201645
+4K1532776200 Ultrasound System and 6250 Ultrasound SystemEsaote, S.p.A.201612—
+4K153647TSolution One w/ACG+ Surgical SystemTHINK Surgical, Inc.20168—
+4K141989Makoplasty Total Hip Allpication, Rio Standard SystemMako Surgical Corporation201483
+4K140927Universal Navigation InstrumentsMedos International SARL20141—
+4K140677MylabssognoEsaote, S.p.A.20140—