510(k) Report

Devices descending from K042721

187 later devices reach Kolibri Spine through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K130887S4C Navigation InstrumentsAesculap Implant System, Inc.201313—
+1K110204Brainlab TraumaBrainlab AG201127—
+1K062086NavivisionBrainlab AG200677—
+1K053159Vectorvision SpineBrainlab AG20061551
+2K221618Spine & Trauma Navigation, Spine Navigation, Navigation Software Spine & Trauma…Brainlab AG20226—
+2K181890Brainlab Compatible K2M Navigation InstrumentsK2m201811—
+2K153700Aesculap (R) Implant Systems (AIS) S4 Navigation InstrumentsAesculap Implant Systems, LLC20160—
+2K122011Navigation Software Hip-Universal; Navigation Software Hip THR-AesculapBrainlab AG201251
+2K081509Monteris Medical Autolitt Laser ProbeMonteris Medical,200922—
+2K081386Model 6150 (MYLAB70) and Model 6100 (MYLAB90)Esaote, S.p.A.2008532
+2K070106VV Fluoro 3DBrainlab AG2007119Class I
+2K063408Ctlogics Navigations SystemsPraxim Medivision, SA200734—
+3K262257Spine Planning (3.0); Spine & Trauma Navigation; Alignment System SpineBrainlab SE20260—
+3K252562Spine & Trauma Navigation InstrumentsBrainlab AG20250—
+3K242569Mixed Reality Spine NavigationBrainlab AG20250—
+3K241893CROSSNAV Navigation Enabled Instruments and UNAS Navigation ArraysMedos International SARL20241—
+3K240701Drill Guide; Drill Bit; Spine & Trauma NavigationBrainlab AG20240—
+3K192703Cranial Image Guided Surgery System, Navigation Software Cranial, Navigation Software…Brainlab AG20203—
+3K201006K2M Navigation InstrumentsK2m, Inc.20200—
+3K193307HIP7Brainlab AG20200—
+3K192911Brainlab Compatible K2M Navigation InstrumentsK2m, Inc.20199—
+3K191285Spine & Trauma NavigationBrainlab AG20190—
+3K182036NeuroBlate SystemMonteris Medical,201811—
+3K181449Ortoma Treatment Solution - OTSOrtoma AB20183—
+3K172115Navigated Instrument SystemOrthofix, Inc.20184—
+3K172881NeuroBlate SystemMonteris Medical,201713—
+3K162567ExactechGPS Total Shoulder Application, Equinoxe Planning SoftwareBlue Ortho2017151
+3K162921Navigated Instrument SystemOrthofix, Inc.20175—
+3K140927Universal Navigation InstrumentsMedos International SARL20141—
+3K142008Mylabseven, MylabalphaEsaote, S.p.A.2014193
+3K1339056200 / 6250 Ultrasound SystemEsaote, S.p.A.201434—
+3K120561Neuroblate SystemMonteris Medical, Inc.2013211
+3K122211Synthes Navigable Pedicle Preparation InstrumentsSynthes Spine201220—
+3K120867Viper and Expedium Navigated InstrumentsMedos International SARL20122—
+3K1031526250 Ultrasound SytemsEsaote, S.p.A.201135—
+3K100931Mylabtwice, Model 6200Esaote, S.p.A.201046—
+3K091009MY LABS25 Gold/MYLAB30 Gold Cardiovascular Model 7340, MY LAB70/MY LAB70XVISION/MYLAB60…Esaote, S.p.A.200951—
+3K083310Spine & Trauma IctBrainlab AG200940—
+3K081232Total Knee Surgetics Navigation System with PraxitelesPraxim200818—
+4K254157CROSSNAV Navigation Enabled Instruments for Disc Preparation and InterbodyMedos International SARL20260—
+4K232140OTS HipOrtoma AB202421
+4K231061NeuroBlate SystemMonteris Medical,20236—
+4K223864Alignment System Cranial, Alignment Software Cranial, Cirq Alignment Software Cranial…Brainlab AG20231—
+4K223288Cranial Navigation, Navigation Software Cranial, Navigation Software Craniofacial…Brainlab AG20230—
+4K223108TELIGEN System Navigation Ready Indications (TELIGEN Access Probe, TELIGEN Clear)Medos International SARL20234—
+4K213491Universal Pilot Guidance Instrument SystemCtl Medical Corporation20220—
+4K212756Discectomy Navigation Ready Instruments and Universal Navigation Adaptor SetMedos International SARL20225—
+4K203205Navigated Spine InstrumentsStryker Spine20218—
+4K201661Symphony Navigation Ready Instruments and Universal Navigation Adaptor SetMedos International SARL20207—
+4K201056NeuroBlate SystemMonteris Medical, Inc.20209—
+4K192495Black Diamond Navigation InstrumentsOsseus Fusion Systems20200—
+4K193375NeuroBlate SystemMonteris Medical,202010—
+4K191722Vital Navigation SystemZimmer Biomet Spine, Inc.20192—
+4K192133Zimmer Biomet Universal Navigation SystemZimmer Biomet Spine, Inc.20190—
+4K190556Zimmer Biomet Universal Navigation SystemZimmer Biomet Spine, Inc.20190—
+4K191943SYMPHONY Navigation Ready Instruments, Universal Navigation Adaptor SetMedos International SARL20198—
+4K183605Spine & Trauma NavigationBrainlab AG2019253
+4K173372ExactechGPS Total Shoulder ApplicationBlue Ortho2017141
+4K173305NeuroBlate SystemMonteris Medical,201712—
+4K170937VIPER PRIME navigated inserterMedos International SARL20176—
+4K170724NeuroBlate SystemMonteris Medical,201715—
+4K161999AixplorerSupersonic Imagine201620—
+4K162762NeuroBlate SystemMonteris Medical, Inc.201616—
+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—
+4K141983Neuroblate SystemMonteris Medical Corp.2014182
+4K140677MylabssognoEsaote, S.p.A.20140—
+4K132466Mylabseven 6400, Mylabalpha 7400Esaote, S.p.A.201322—
+4K132231Mylabseven, MylabalphaEsaote, S.p.A.201322—
+4K131955Neuroblate (TM) SystemMonteris Medical, Inc.2013192
+4K131278Monteris Medical Neuroblate SystemMonteris Medical, Inc.2013191
+4K121384MylabsognoEsaote, S.p.A.201211
+4K111302Mylabseven, MylabalphaEsaote, S.p.A.201124—
+4K110688MylabgoldEsaote2011251
+4K090953Total Knee Surgetics Navigation System with IblockPraxim Medivision, SA2010172
+5K260240SYMPHONY Navigation Ready InstrumentsMedos International SARL20260—
+5K250086OTS HipOrtoma AB202511
+5K243698Alignment System Cranial, with Alignment Software Cranial with LITT; Cirq Alignment…Brainlab AG20250—
+5K242271Caduceus STaiwan Main Orthopaedic Biotechnology Co., Ltd.20240—
+5K233254TELIGEN System Navigation Ready InstrumentsDePuy Synthes20242—
+5K240662Spine Guidance Software (version 5.0); Xia 3/ Serrato Q Instruments; Everest Q…Stryker Leibinger GmbH & Co KG20247—
+5K240877Monteris Medical NeuroBlate SystemMonteris Medical,20245—
+5K233443Vital™ Navigation SystemZimvie Spine (Zimmer Biomet Spine, Inc.)20230—
+5K231280CarboClear® X Pedicle Screw System; CarboClear® X Navigated Instruments; CarboClear® X…CarboFix Orthopedics, Ltd.20234—
+5K222983NeuroBlate Fusion-S Software V3.17Monteris Medical,20237—
+5K223438TELIGEN System Peripheral Motor Nerve Stimulation IndicationsMedos International SARL20230—
+5K222510Blueprint Mixed Reality systemTornier S.A.S.2023010
+5K220554Caduceus STaiwan Main Orthopaedic Biotechnology Co., Ltd.20220—
+5K212245Spine and Trauma Navigation System, Spine & Trauma 3D Navigation, Instrument Selection…Brainlab AG202215—
+5K213720Vital Navigation SystemZimvie (Zimmer Biomet Spine, Inc.)20220—
+5K211269Visualase MRI-Guided Laser Ablation System (SW 3.4)Medtronic Navigation, Inc.202271
+5K213546ExactechGPS Total Shoulder Application, Equinoxe Planning SoftwareBlue Ortho202281
+5K210153NextAR RSA PlatformMedacta International S.A.202151
+5K203679Automatic RegistrationBrainlab AG20211—
+5K202769VELYS™ Robotic-Assisted SolutionDepuy Ireland UC202131
+5K202320CIRQ Robotic Alignment Module, Cirq, Cirq Robotic Alignment Module Spinal, Cirq Robotic…Brainlab AG20209—
+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—