510(k) Report

Devices descending from K042721

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

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+5K1831916420 Ultrasound SystemEsaote, S.p.A.20180—
+5K163338OMNIBotics Knee SystemOmnllife Science, Inc.201712—
+5K171255Monteris Medical NeuroBlate SystemMonteris Medical, Inc.201714Class I
+5K171105AIXPLORER® & AIXPLORER® Ultimate Ultrasound SystemsSupersonic Imagine201719—
+5K163119NaviSuite SSI EditionMedcom GmbH20171—
+5K1630826200 Ultrasound System and 6250 Ultrasound SystemEsaote, S.p.A.201792
+5K162290MyLabSix CrystaLineEsaote, S.p.A.20160—
+5K143457NeuroBlate SystemMonteris Medical, Inc.201517Class I
+5K142077MylabgammaEsaote, S.p.A.201453
+5K141486Mylabsix Ultrasound SystemEsaote Europe B.V.20148—
+6K262315NeuroBlate SystemMonteris Medical20260—
+6K261852OTS HipOrtoma AB20260—
+6K260976NeuroBlate SystemMonteris Medical20261—
+6K254158SPINEART Navigation Instrument SystemSpineart SA20261—
+6K260546Q Pedicle InstrumentsK2m, Inc.20260—
+6K253391Visualase Cooled Laser Applicator System (9735559); Visualase Cooled Laser Applicator…Medtronic Navigation, Inc.20260—
+6K252873Q Interbody InstrumentsK2m, Inc.20260—
+6K252871Spine Guidance 5.3 Software; Q Interbody Instruments; Elite Q Attachments; Elite Cutting…Stryker Leibinger GmbH & Co KG20261—
+6K252755POINT Kinguide Agile Robotic Arm Surgical Stereotactic SystemPoint Robotics MedTech, Inc.20260—
+6K252847NextAR Hip PlatformMedacta International S.A.20260—
+6K252841Real Intelligence™ Cori™ XT (Cori XT)Blue Belt Technologies, Inc.20250—
+6K251737NextAR (TM) Shoulder PlatformMedacta International S.A.20250—
+6K251298Mobile Laser Unit (1001-N2); Thermoguide Workstation (1100-N1); Laser Applicator…Clinical Laserthermia Systems, AB20250—
+6K250108OptiVu™ ShoulderMr Surgical Solutions, LLC20251—
+6K242933SPINEART Navigation Instrument SystemSpineart SA20252—
+6K250307Visualase V2 MRI-guided Laser Ablation System (9736422)Medtronic Navigation20251—
+6K233793CarboClear® X Pedicle Screw SystemCarboFix Orthopedics, Ltd.20241—
+6K241171Spine Guidance Software (Version 5.1); Consolidated Operating Room Equipment (CORE) 2…Stryker Leibinger GmbH & Co KG20244—
+6K240721ExcelsiusFlex™Globus Medical, Inc.20240—
+6K240846CarboClear® Hybrid Pedicle Screw System; CarboClear® Hybrid Navigated Instruments…CarboFix Orthopedics, Ltd.20242—
+6K234047Automatic RegistrationBrainlab AG20240—
+6K233199ROSA® Shoulder SystemOrthosoft Inc (D/B/A Zimmer Cas)20243—
+6K233944CarboClear® X Pedicle Screw System; CarboClear® X Navigated InstrumentsCarboFix Orthopedics, Ltd.20243—
+6K233227VELYS™ Robotic-Assisted SolutionDepuy Ireland UC20231—
+6K232521ExactechGPS® Total Ankle ApplicationBlue Ortho20230—
+6K232280NextAR™ TSA PlatformMedacta International S.A.20231—
+6K223553Spine Planning (2.0), Elements Spine Planning, Elements Planning SpineBrainlab AG20231—
+6K230904Arthrex Virtual Implant Positioning (VIP) SystemArthrex, Inc.20231—
+6K222966Cirq Arm System (2.0);Alignment System SpineBrainlab AG202201
+6K200888OMNIBotics Knee SystemCorin, Ltd.202011—
+6K1732916440 Ultrasound SystemEsaote, S.p.A.20188—
+6K173021Aixplorer & Aixplorer Ultimate Ultrasound Diagnostic SystemsSupersonic Imagine201818—
+6K170841BiopSee, Mobile USMedcom GmbH20170—
+7K261205SPINEART Navigation Instrument SystemSpineart SA20260—
+7K260480VELYS™ Robotic-Assisted SolutionDepuy Ireland UC20260—
+7K260582ROSA® Shoulder SystemOrthosoft Inc. (d/b/a) Zimmer CAS20260—
+7K253623Spine Guidance 5.4 Software; Spine Guidance 5.4 Upgrade; Spine Guidance 5.4 Update…Stryker Leibinger GmbH & Co KG20260—
+7K252170OptiVu™ ShoulderMr Surgical Solutions, LLC20250—
+7K243958Consolidated Operating Room Equipment (CORE) 2 ConsoleStryker Instruments20250—
+7K243106CarboClear® Hybrid Pedicle Screw SystemCarboFix Orthopedics, Ltd.20240—
+7K241097Arthrex Virtual Implant Positioning (VIP) System SoftwareArthrex, Inc.20240—
+7K241517Q Guidance System; Mako Spine System;Stryker Leibinger GmbH & Co KG20242—
+7K2301796440 MyLabX90Esaote, S.p.A.202341
+7K231172ApolloKneeCorin U.S.A. Limited20230—
+7K221224Real Intelligence CoriBlue Belt Technologies, Inc.20229—
+7K200655FibroScan® 630Echosens20200—
+7K1921576450 Ultrasound systemEsaote, S.p.A.20194—
+7K180572AIXPLORER MACH Ultrasound Diagnostic Systems Aixplorer Mach 30, Aixplorer Mach 20…Supersonic Imagine201816—
+8K2432536600 Ultrasound System (MyLabA50); 6600 Ultrasound System (MyLabA70)Esaote, S.p.A.20252—
+8K2416716450 Ultrasound System (MyLabE80); 6450 Ultrasound System (MyLabE85)Esaote, S.p.A.20252—
+8K240113CORIOGRAPH Knee Pre-Op PlanSmith & Nephew, Inc.20242—
+8K231963Real Intelligence™ Cori™Blue Belt Technologies, Inc.202342
+8K230876RI.KNEE Adjustable Tibia Cut GuideEnztec Limited20230—
+8K2120216430 MyLabX75, 6430 MyLab XPro75Esaote, S.p.A.20210—
+8K191007Aixplorer MACH 30, Aixplorer MACH 20 Ultrasound Diagnostic SystemsSupersonic Imagine20195—
+8K191467Aplio i900/i800/i700/i600 Diagnostic Ultrasound System, V4.0Canon Medical Systems Corporation20199—
+9K261272ePascal S/ ePascal SOR/ ePascal S5/ ePascal SA/ ePascal SE/ ePascal 80Elite/ ePascal 80/…Esonic Technology (Wuhan) Co., Ltd.20260—
+9K2532886450 Ultrasound System (MyLabE80); 6450 Ultrasound System (MyLabE85)Esaote, S.p.A.20260—
+9K2533107600 Ultrasound System (MyLabC25); 7600 Ultrasound System (MyLabC30)Esaote, S.p.A.20250—
+9K242272CORIOGRAPH Pre-Op Planning and Modeling ServicesBlue Belt Technologies, Inc.20241—
+9K240139Real Intelligence™ CORI™Blue Belt Technologies, Inc.202431
+9K203645Aixplorer MACH30/ SUPERSONIC MACH30, Aixplorer MACH20/ SUPERSONIC MACH20, SUPERSONIC…Supersonic Imagine20212—
+9K202455Aixplorer®MACH20, Aixplorer®MACH30, Supersonic MACH40, Supersonic MACH30 & Supersoinc…Supersonic Imagine20200—
+9K202737Aplio i900/i800/i700/i600 Diagnostic Ultrasound System, Aplio a550, Aplio a450, and…Canon Medical Systems Corporation20200—
+9K201972Aplio i900/i800/i700 Diagnostic Ultrasound System, Software V5.1Canon Medical Systems Corporation20207—
+10K260601Real Intelligence™ Cori™Blue Belt Technologies, Inc.20260—
+10K251971RPS Primary TKA Software; RPS Console; RPS Saw One; RPS Cable; RPS Saw Oscillating Tip…Stryker Instruments20250—
+10K250921CORIOGRAPH Pre-Op Planning and Modeling ServicesBlue Belt Technologies, Inc.20250—
+10K222191Aixplorer MACH30 / SUPERSONIC MACH30, Aixplorer MACH20 / SUPERSONIC , MACH20, SUPERSONIC…Supersonic Imagine20221—
+10K212333Aplio i900/i800/i700 Diagnostic Ultrasound System, Software V6.5Canon Medical Systems Corporation202261
+11K242223SuperSonic HepaVuSupersonic Imagine20240—
+11K223017Aplio i900/i800/i700 Diagnostic Ultrasound System, Software V7.0Canon Medical Systems Corporation20235—
+12K241582Aplio i900/i800/i700 Diagnostic Ultrasound System, Software V7.0 (TUS-AI900, TUS-AI800…Canon Medical Systems Corporation20240—
+12K233195Aplio i900, Aplio i800 and Aplio i700 Software V8.1 Diagnostic Ultrasound SystemCanon Medical Systems Corporation20243—
+13K242808Aplio i900/i800/i700 Diagnostic Ultrasound System, Software V8.5Canon Medical Systems Corporation20252—
+14K253597Aplio beyond and Aplio me Software V2.0 Diagnostic Ultrasound SystemCanon Medical Systems Corporation20260—
+14K252074Aplio i900, Aplio i800 and Aplio i700 Software V9.0 Diagnostic Ultrasound SystemCanon Medical Systems Corporation20250—