510(k) Report

Devices descending from K014256

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

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+6K173021Aixplorer & Aixplorer Ultimate Ultrasound Diagnostic SystemsSupersonic Imagine201818—
+6K163338OMNIBotics Knee SystemOmnllife Science, Inc.201712—
+6K170841BiopSee, Mobile USMedcom GmbH20170—
+6K171255Monteris Medical NeuroBlate SystemMonteris Medical, Inc.201714Class I
+6K170584Mako Partial Knee ApplicationMako Surgical Corp.201722
+6K170430TSolution One Surgical System Model 210THINK Surgical, Inc.20176—
+6K142530Partial Knee Application (PKA)Mako Surgical Corporation20153—
+6K143752Total Knee Application (TKA)Mako Surgical Corp.2015442
+6K143668NavioBlue Belt Technologies, Inc.201520—
+6K143457NeuroBlate SystemMonteris Medical, Inc.201517Class I
+6K130387Orthoalign Plus SystemOrthalign, Inc.201331—
+6K122326Smarttools Knee SystemZimmer201232
+6K092497Smith & Nephew Pigalileo Screw Targeting System, Version 1.1Smith & Nephew, Inc.200977—
+7K262315NeuroBlate SystemMonteris Medical20260—
+7K260976NeuroBlate SystemMonteris Medical20261—
+7K254158SPINEART Navigation Instrument SystemSpineart SA20261—
+7K260546Q Pedicle InstrumentsK2m, Inc.20260—
+7K253391Visualase Cooled Laser Applicator System (9735559); Visualase Cooled Laser Applicator…Medtronic Navigation, Inc.20260—
+7K252873Q Interbody InstrumentsK2m, Inc.20260—
+7K252871Spine Guidance 5.3 Software; Q Interbody Instruments; Elite Q Attachments; Elite Cutting…Stryker Leibinger GmbH & Co KG20261—
+7K252755POINT Kinguide Agile Robotic Arm Surgical Stereotactic SystemPoint Robotics MedTech, Inc.20260—
+7K252847NextAR Hip PlatformMedacta International S.A.20260—
+7K252841Real Intelligence™ Cori™ XT (Cori XT)Blue Belt Technologies, Inc.20250—
+7K251737NextAR (TM) Shoulder PlatformMedacta International S.A.20250—
+7K251298Mobile Laser Unit (1001-N2); Thermoguide Workstation (1100-N1); Laser Applicator…Clinical Laserthermia Systems, AB20250—
+7K250108OptiVu™ ShoulderMr Surgical Solutions, LLC20251—
+7K242933SPINEART Navigation Instrument SystemSpineart SA20252—
+7K250307Visualase V2 MRI-guided Laser Ablation System (9736422)Medtronic Navigation20251—
+7K242121mBôs (Monogram mBôs TKA System)Monogram Orthopaedics, Inc.20250—
+7K243387GYDER® Hip SystemGyder Surgical Pty, Ltd.20251—
+7K233793CarboClear® X Pedicle Screw SystemCarboFix Orthopedics, Ltd.20241—
+7K241171Spine Guidance Software (Version 5.1); Consolidated Operating Room Equipment (CORE) 2…Stryker Leibinger GmbH & Co KG20244—
+7K240721ExcelsiusFlex™Globus Medical, Inc.20240—
+7K240846CarboClear® Hybrid Pedicle Screw System; CarboClear® Hybrid Navigated Instruments…CarboFix Orthopedics, Ltd.20242—
+7K234047Automatic RegistrationBrainlab AG20240—
+7K233199ROSA® Shoulder SystemOrthosoft Inc (D/B/A Zimmer Cas)20243—
+7K233944CarboClear® X Pedicle Screw System; CarboClear® X Navigated InstrumentsCarboFix Orthopedics, Ltd.20243—
+7K233227VELYS™ Robotic-Assisted SolutionDepuy Ireland UC20231—
+7K2301796440 MyLabX90Esaote, S.p.A.202341
+7K232521ExactechGPS® Total Ankle ApplicationBlue Ortho20230—
+7K232280NextAR™ TSA PlatformMedacta International S.A.20231—
+7K223553Spine Planning (2.0), Elements Spine Planning, Elements Planning SpineBrainlab AG20231—
+7K230904Arthrex Virtual Implant Positioning (VIP) SystemArthrex, Inc.20231—
+7K222966Cirq Arm System (2.0);Alignment System SpineBrainlab AG202201
+7K210121ROSA Partial Knee SystemOrthosoft D/B/A Zimmer Cas20211—
+7K200655FibroScan® 630Echosens20200—
+7K193515Mako Total Knee ApplicationMako Surgical Corp.202016
+7K200888OMNIBotics Knee SystemCorin, Ltd.202011—
+7K193128Mako Total Hip ApplicationMako Surgical Corp.20203—
+7K1921576450 Ultrasound systemEsaote, S.p.A.20194—
+7K192080iASSIST Knee SystemOrthosoft Inc (D/B/A Zimmer Cas)20191—
+7K191369TSolution One Total Knee ApplicationTHINK Surgical, Inc.20195—
+7K180572AIXPLORER MACH Ultrasound Diagnostic Systems Aixplorer Mach 30, Aixplorer Mach 20…Supersonic Imagine201816—
+7K180277Smith & Nephew SURESHOT Distal Targeting System V4.0 TargeterSmith & Nephew, Inc.20180—
+7K170891Mako Partial Knee ApplicationMako Surgical Corp.201723
+7K170581Mako Total Knee ApplicationMako Surgical Corp.2017381
+7K170280Smith & Nephew SURESHOT Distal Targeting System V4.0Smith & Nephew, Inc.20170—
+7K152574NavioBlue Belt Technologies, Inc.201519—
+7K141601Iassist Knee SystemZimmer Cas20142—
+7K130748Smith & Nephew Sureshot Distal Targeting System V3.0Smith & Nephew, Inc.20131—
+7K110670VLP Foot Talus Plates, VLP Percutaneous Calcaneus Plates and Misc VLP Bone Screws…Smith & Nephew, Inc.201169—
+7K110240Smith & Nephew, Inc. Sureshot Distal Targeting System V2.1Smith & Nephew, Inc.20112—
+7K102967Smith & Nephew, Inc. Sureshot Distal Targeting System V2.0.2Smith & Newphew, Inc.20103—
+7K100107Smith & Nephew Sureshot Distal Targeting System V2.0Smith & Nephew, Inc.2010751
+8K261205SPINEART Navigation Instrument SystemSpineart SA20260—
+8K260480VELYS™ Robotic-Assisted SolutionDepuy Ireland UC20260—
+8K260582ROSA® Shoulder SystemOrthosoft Inc. (d/b/a) Zimmer CAS20260—
+8K252037CUVIS-joint (CJ150)Curexo, Inc.20260—
+8K253623Spine Guidance 5.4 Software; Spine Guidance 5.4 Upgrade; Spine Guidance 5.4 Update…Stryker Leibinger GmbH & Co KG20260—
+8K252170OptiVu™ ShoulderMr Surgical Solutions, LLC20250—
+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—
+8K243958Consolidated Operating Room Equipment (CORE) 2 ConsoleStryker Instruments20250—
+8K243751Mako Total Hip Application 5.0Mako Surgical Corp.20251—
+8K243106CarboClear® Hybrid Pedicle Screw SystemCarboFix Orthopedics, Ltd.20240—
+8K241097Arthrex Virtual Implant Positioning (VIP) System SoftwareArthrex, Inc.20240—
+8K241517Q Guidance System; Mako Spine System;Stryker Leibinger GmbH & Co KG20242—
+8K232533ROSA Partial Knee SystemOrthosoft D/B/A Zimmer Cas20230—
+8K231172ApolloKneeCorin U.S.A. Limited20230—
+8K220774RobPath® Total Hip ApplicationHangzhou Lancet Robotics Co., Ltd.20220—
+8K213126Smith & Nephew, Inc. Plates and Screws Systems: EVOS, Peri-Loc, D-Rad, TC-100, VLP…Smith & Nephew, Inc.202221
+8K221224Real Intelligence CoriBlue Belt Technologies, Inc.20229—
+8K213033iASSIST Knee SystemOrthosoft D/B/A Zimmer Cas20220—
+8K2120216430 MyLabX75, 6430 MyLab XPro75Esaote, S.p.A.20210—
+8K210837Smith & Nephew Plates and ScrewsSmith & Nephew, Inc.202171
+8K201255TSolution® One Total Knee ApplicationTHINK Surgical, Inc.20203—
+8K193135TSolution One Total Knee ApplicationTHINK Surgical, Inc.20194—
+8K191007Aixplorer MACH 30, Aixplorer MACH 20 Ultrasound Diagnostic SystemsSupersonic Imagine20195—
+8K191467Aplio i900/i800/i700/i600 Diagnostic Ultrasound System, V4.0Canon Medical Systems Corporation20199—
+8K172301Mako Partial Knee ApplicationMako Surgical Corp.201716
+8K172219Mako Total Knee ApplicationMako Surgical Corp.201737—
+8K170977SURESHOT Distal Targeting System V4.0 Trauma InterfaceSmith & Nephew, Inc.20170—
+8K160537NavioBlue Belt Technologies, Inc.201618—
+8K152976VLP Mini-Mod Talus PlatesSmith & Nephew, Inc.20158—
+8K140792Salvation 3DI Plating SystemWrightmedicaltechnologyinc201421
+8K140408Salvation Osteopenic ScrewWrightmedicaltechnologyinc20141—
+8K133930Flower Rear Foot Plating Set, Flower Calcaneus Planting Set, Flower Rearfoot Plating SetFlower Orthopedics Corporation201406
+8K123347Normed Ankle Fix System 4.0 and Normed Ankle Fix Plus System 4.0Normed Medizin-Technik GmbH201322
+8K121425Ortholoc 3DI Ankle Fusion Plating SystemWrightmedicaltechnologyinc201253—
+8K120667VLP 2.7MM Extra Large Percutaneous Calcaneus Plate, Peri-Loc 3.5MM Anterior Ankle Fusion…Smith & Nephew, Inc.20129—