510(k) Report

Devices descending from K014256

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

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+4K132466Mylabseven 6400, Mylabalpha 7400Esaote, S.p.A.201322—
+4K132231Mylabseven, MylabalphaEsaote, S.p.A.201322—
+4K120561Neuroblate SystemMonteris Medical, Inc.2013211
+4K122211Synthes Navigable Pedicle Preparation InstrumentsSynthes Spine201220—
+4K120867Viper and Expedium Navigated InstrumentsMedos International SARL20122—
+4K121384MylabsognoEsaote, S.p.A.201211
+4K111443X12 Sterile Reflective Marker SpherePinsco Inc. Dba B & L Engineering20110—
+4K111302Mylabseven, MylabalphaEsaote, S.p.A.201124—
+4K110688MylabgoldEsaote2011251
+4K102990Brainlab KneeBrainlab AG201171
+4K103192Navigation Marker, Reflective Marker SpheresIlumark GmbH20111—
+4K093118Brainlab Knee ArthroscopyBrainlab AG20100—
+4K093998Kneealign System with Reference SensorOrthalign, Inc.201040—
+4K091411Kneealign SystemOrthalign, Inc.200941—
+4K083310Spine & Trauma IctBrainlab AG200940—
+4K083565Pigalileo Total Hip Replacement (THR) Software Application V3.0Smith & Nephew, Inc.20090—
+4K081867Mako Surgical Tactile Guidance System Version 2.0Mako Surgical Corp.2008762
+4K081232Total Knee Surgetics Navigation System with PraxitelesPraxim200818—
+4K080875Pigalileo 4TH Generation SystemSmith & Nephew, Inc.200879—
+5K254157CROSSNAV Navigation Enabled Instruments for Disc Preparation and InterbodyMedos International SARL20260—
+5K250086OTS HipOrtoma AB202511
+5K243950ARVIS® ShoulderKico Knee Innovation Company Pty, Ltd.202502
+5K231061NeuroBlate SystemMonteris Medical,20236—
+5K223864Alignment System Cranial, Alignment Software Cranial, Cirq Alignment Software Cranial…Brainlab AG20231—
+5K223108TELIGEN System Navigation Ready Indications (TELIGEN Access Probe, TELIGEN Clear)Medos International SARL20234—
+5K213491Universal Pilot Guidance Instrument SystemCtl Medical Corporation20220—
+5K212756Discectomy Navigation Ready Instruments and Universal Navigation Adaptor SetMedos International SARL20225—
+5K203751OMNIVision systemCorin USA20210—
+5K203205Navigated Spine InstrumentsStryker Spine20218—
+5K202609Instrument Clamps ElectromagneticStryker Corporation20200—
+5K201661Symphony Navigation Ready Instruments and Universal Navigation Adaptor SetMedos International SARL20207—
+5K192653PerseusOrthokey Italia S.R.L.20200—
+5K201056NeuroBlate SystemMonteris Medical, Inc.20209—
+5K200892Harvey (R) Surgical AssistantOrthalign, Inc.202022
+5K193094Naviswiss Hip Navigation SystemNaviswiss AG20201—
+5K193118TGS Guidewire and updated Scopis SoftwareStryker Ent20201—
+5K192495Black Diamond Navigation InstrumentsOsseus Fusion Systems20200—
+5K193375NeuroBlate SystemMonteris Medical,202010—
+5K191722Vital Navigation SystemZimmer Biomet Spine, Inc.20192—
+5K192133Zimmer Biomet Universal Navigation SystemZimmer Biomet Spine, Inc.20190—
+5K190556Zimmer Biomet Universal Navigation SystemZimmer Biomet Spine, Inc.20190—
+5K191943SYMPHONY Navigation Ready Instruments, Universal Navigation Adaptor SetMedos International SARL20198—
+5K183605Spine & Trauma NavigationBrainlab AG2019253
+5K1910727410 Ultrasound System (MyLabSigma)Esaote, S.p.A.20190—
+5K1909896400 Ultrasound System (MyLabX6, MyLabX7)Esaote, S.p.A.20190—
+5K1904477400 Ultrasound SystemsNavigant Consulting - on Behalf of Esaote S.P.A.20190—
+5K1831916420 Ultrasound SystemEsaote, S.p.A.20180—
+5K173372ExactechGPS Total Shoulder ApplicationBlue Ortho2017141
+5K173305NeuroBlate SystemMonteris Medical,201712—
+5K171525Intellijoint HIP Generation 2B SystemIntellijoint Surgical, Inc.20173—
+5K170937VIPER PRIME navigated inserterMedos International SARL20176—
+5K171105AIXPLORER® & AIXPLORER® Ultimate Ultrasound SystemsSupersonic Imagine201719—
+5K171780OrthAlign Plus SystemOrthalign, Inc.201712—
+5K163119NaviSuite SSI EditionMedcom GmbH20171—
+5K170593Mako Total Hip ApplicationMako Surgical Corp.201771
+5K170724NeuroBlate SystemMonteris Medical,201715—
+5K1630826200 Ultrasound System and 6250 Ultrasound SystemEsaote, S.p.A.201792
+5K162762NeuroBlate SystemMonteris Medical, Inc.201616—
+5K162290MyLabSix CrystaLineEsaote, S.p.A.20160—
+5K162195TSolution One Cup1 Surgical SystemTHINK Surgical, Inc.20167—
+5K142077MylabgammaEsaote, S.p.A.201453
+5K141983Neuroblate SystemMonteris Medical Corp.2014182
+5K141486Mylabsix Ultrasound SystemEsaote Europe B.V.20148—
+5K140596NAVIOBlue Belt Technologies, Inc.201421—
+5K131955Neuroblate (TM) SystemMonteris Medical, Inc.2013192
+5K131278Monteris Medical Neuroblate SystemMonteris Medical, Inc.2013191
+5K121936NaviopfsBlue Belt Technologies, Inc.2012222
+5K112507Restoris Partial Knee Application (Pka), Rio Standard SystemMako Surgical Corporation2012466
+5K103829Kneealign SystemOrthalign, Inc.201139—
+5K090953Total Knee Surgetics Navigation System with IblockPraxim Medivision, SA2010172
+5K090420Smith & Nephew Pigalileo Screw Targeting System V 1.0Smith & Nephew, Inc.200978—
+6K261852OTS HipOrtoma AB20260—
+6K253507Packaged Assembly, Reusable Navigation Unit; Lantern ASC, Smart Pack kit, KneeOrthalign, Inc.20260—
+6K260240SYMPHONY Navigation Ready InstrumentsMedos International SARL20260—
+6K243698Alignment System Cranial, with Alignment Software Cranial with LITT; Cirq Alignment…Brainlab AG20250—
+6K242271Caduceus STaiwan Main Orthopaedic Biotechnology Co., Ltd.20240—
+6K242616Lantern® HipOrthalign, Inc.20241—
+6K233254TELIGEN System Navigation Ready InstrumentsDePuy Synthes20242—
+6K240662Spine Guidance Software (version 5.0); Xia 3/ Serrato Q Instruments; Everest Q…Stryker Leibinger GmbH & Co KG20247—
+6K240877Monteris Medical NeuroBlate SystemMonteris Medical,20245—
+6K233443Vital™ Navigation SystemZimvie Spine (Zimmer Biomet Spine, Inc.)20230—
+6K231280CarboClear® X Pedicle Screw System; CarboClear® X Navigated Instruments; CarboClear® X…CarboFix Orthopedics, Ltd.20234—
+6K222983NeuroBlate Fusion-S Software V3.17Monteris Medical,20237—
+6K223438TELIGEN System Peripheral Motor Nerve Stimulation IndicationsMedos International SARL20230—
+6K223351Naviswiss KneeNaviswiss AG20230—
+6K222510Blueprint Mixed Reality systemTornier S.A.S.2023010
+6K220554Caduceus STaiwan Main Orthopaedic Biotechnology Co., Ltd.20220—
+6K221098Scopis ENT Software, Scopis ENT Software with TGS, Scopis Planning Software…Stryker Corporation202201
+6K212245Spine and Trauma Navigation System, Spine & Trauma 3D Navigation, Instrument Selection…Brainlab AG202215—
+6K213720Vital Navigation SystemZimvie (Zimmer Biomet Spine, Inc.)20220—
+6K211269Visualase MRI-Guided Laser Ablation System (SW 3.4)Medtronic Navigation, Inc.202271
+6K213546ExactechGPS Total Shoulder Application, Equinoxe Planning SoftwareBlue Ortho202281
+6K210153NextAR RSA PlatformMedacta International S.A.202151
+6K203679Automatic RegistrationBrainlab AG20211—
+6K202769VELYS™ Robotic-Assisted SolutionDepuy Ireland UC202131
+6K202320CIRQ Robotic Alignment Module, Cirq, Cirq Robotic Alignment Module Spinal, Cirq Robotic…Brainlab AG20209—
+6K200642OrthAlign Plus SystemOrthalign, Inc.20200—
+6K191507Intellijoint® Navigation SystemIntellijoint Surgical, Inc.201922
+6K191998Mako Total Hip Application, Mako Total Knee ApplicationMako Surgical Corp.20196—
+6K1732916440 Ultrasound SystemEsaote, S.p.A.20188—