510(k) Report

Devices descending from K014256

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

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+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—
+9K260274Airlock® Ankle Plating SystemNovastep SAS20260—
+9K253713Arthrex Variable Angle (VA) Proximal Tibia Plating SystemArthrex, Inc.20260—
+9K2533107600 Ultrasound System (MyLabC25); 7600 Ultrasound System (MyLabC30)Esaote, S.p.A.20250—
+9K252019CurvaFix Low Profile SystemCurvafix, Inc.20250—
+9K243963Pediatric Plating Platform HipOrthoPediatrics Corp.20250—
+9K242373Mako Shoulder Application (1.0)Mako Surgical Corp.20240—
+9K233816REDEMPTION Charcot Plating SystemVilex, LLC20240—
+9K240113CORIOGRAPH Knee Pre-Op PlanSmith & Nephew, Inc.20242—
+9K233396Cannulated Screw SystemSmith & Nephew, Inc.20230—
+9K233017TM Plating SystemTyber Medical, LLC20231—
+9K231963Real Intelligence™ Cori™Blue Belt Technologies, Inc.202342
+9K230876RI.KNEE Adjustable Tibia Cut GuideEnztec Limited20230—
+9K222665Medline UNITE® Ankle Fusion Plating SystemMedline Industries, Inc.20230—
+9K213069CoLink NeoFuse Plating SystemIn2bones USA, LLC20211—
+9K212640Stratum® Ankle Fusion Plating SystemNextremity Solutions, Inc.20210—
+9K203645Aixplorer MACH30/ SUPERSONIC MACH30, Aixplorer MACH20/ SUPERSONIC MACH20, SUPERSONIC…Supersonic Imagine20212—
+9K210157SOLE Medial Column Fusion PlateOrthofix Srl20210—
+9K203479ExtremiLOCK Lateral Ankle Fusion PlatesOsteomed20210—
+9K202455Aixplorer®MACH20, Aixplorer®MACH30, Supersonic MACH40, Supersonic MACH30 & Supersoinc…Supersonic Imagine20200—
+9K202307Activ FuseNewclip Technics20200—
+9K203040TSolution One Total Knee ApplicationTHINK Surgical, Inc.20202—
+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—
+9K182991EPIC Extremity Fusion Plate SystemEpic Extremity, LLC20190—
+9K182964ROSA Knee SystemOrthosoft Inc (D/B/A Zimmer Cas)201929—
+9K182148SILVERBACK Gorilla Plating SystemParagon 28, Inc.20183—
+9K173121Ankle Fusion Plating SystemIn2bones Sas20172—
+9K170360NAVIOBlue Belt Technologies, Inc.201717—
+9K163650ORTHOLOC® 3Di Ankle Fusion Plating System Line ExtensionWrightmedicaltechnologyinc201712—
+9K160191Align Anterior Ankle Fusion PlateExtremity Medical, LLC20165—
+9K140397Paralock Plating System / Tuffnek ScrewParagon 28201431—
+10K261207Exalta Proximal Tibia Plating SystemTyber Medical, LLC20260—
+10K252058ROSA Knee System with UltraSound Imaging Platform (USIP)Balmoral Medical, LLC20260—
+10K242272CORIOGRAPH Pre-Op Planning and Modeling ServicesBlue Belt Technologies, Inc.20241—
+10K241387CoLink NeoFuse MIS Plating System (see attached parts list)In2bones USA20240—
+10K240139Real Intelligence™ CORI™Blue Belt Technologies, Inc.202431
+10K230202TMINI™ Miniature Robotic SystemTHINK Surgical, Inc.2023101
+10K222191Aixplorer MACH30 / SUPERSONIC MACH30, Aixplorer MACH20 / SUPERSONIC , MACH20, SUPERSONIC…Supersonic Imagine20221—
+10K221928ROSA® Knee SystemOrthosoft D/B/A Zimmer Cas20228—
+10K220733OptiVu ROSA MxROrthosoft Inc (D/B/A Zimmer Cas)20221—
+10K213873SkyWalker Total Knee SystemMicroport Navibot International, LLC20220—
+10K213708ROSA® Knee SystemOrthosoft Inc (D/B/A Zimmer Cas)20220—
+10K212333Aplio i900/i800/i700 Diagnostic Ultrasound System, Software V6.5Canon Medical Systems Corporation202261
+10K210998ROSA Hip SystemOrthosoft D/B/A Zimmer Cas20211—
+10K210668TSolution One Total Knee ApplicationTHINK Surgical, Inc.20210—
+10K200398AxSOS 3 AF System and AxSOS 3 Ti SystemStryker GmbH20209—
+10K200762CoLink Cfx Plating SystemIn2bones USA, LLC20201—
+10K181067AlignX Ankle Fusion SystemExtremity Medical, LLC20184—
+10K180271NAVIO™ Surgical System (NAVIO system)Blue Belt Technologies, Inc.201816—
+10K172973Life Spine Foot and Ankle Plating SystemLife Spine, Inc.20170—
+10K172886Breakaway Screw SystemParagon 2820174—
+10K172260Omni Foot Plating SystemExtremity Medical, LLC20174—
+10K170693Phantom Small Bone Intramedullary Nail SystemParagon 28, Inc.20179—
+10K170214Additive Orthopaedics Locking Lattice PlateAdditive Orthopaedics, LLC20178—
+11K260601Real Intelligence™ Cori™Blue Belt Technologies, Inc.20260—
+11K251971RPS Primary TKA Software; RPS Console; RPS Saw One; RPS Cable; RPS Saw Oscillating Tip…Stryker Instruments20250—
+11K250921CORIOGRAPH Pre-Op Planning and Modeling ServicesBlue Belt Technologies, Inc.20250—
+11K242223SuperSonic HepaVuSupersonic Imagine20240—
+11K233154SkyOPS™ Orthopedic Plate SystemSky Surgical, LLC20231—
+11K231887ARIX Ankle Distal Tibia SystemJeil Medical Corporation20231—
+11K232802TMINI™ Miniature Robotic SystemTHINK Surgical, Inc.20239—
+11K231262Pangea Femur Plating System, Pangea Fibula Plating System, Pangea Tibia Plating System…Stryker GmbH20234—
+11K231257Pangea Utility Plating System, Pangea PlatformStryker GmbH20231—
+11K230567OptiVu™ ROSA® MxROrthosoft Inc (D/B/A Zimmer Cas)20230—
+11K231162ROSA Hip SystemOrthosoft Inc (D/B/A Zimmer Cas)20230—
+11K222381PeriPRO™ Femur System, Variable Angle Fixation System, AxSOS 3Ti, Stryker Plating SystemStryker GmbH20238—
+11K223017Aplio i900/i800/i700 Diagnostic Ultrasound System, Software V7.0Canon Medical Systems Corporation20235—
+11K230243ROSA® Knee SystemOrthosoft D/B/A Zimmer Cas20236—
+11K230180Rosa Knee SystemOrthosoft Inc (D/B/A Zimmer Cas)20230—
+11K212297Omni Foot and Ankle Plating SystemExtremity Medical, LLC20211—
+11K201149CoLink Plating SystemIn2bones USA, LLC20200—
+11K191223NAVIOBlue Belt Technologies, Inc.201915—
+11K182307Small Bone Phantom® Intramedullary Nail System; TTC Phantom® Intramedullary Nail SystemParagon 28, Inc.20198—
+11K183011Additive Orthopaedics Patient Specific 3D Locking Lattice PlatesAdditive Orthopaedics20195—
+11K180808Omni Foot Plating SystemExtremity Medical, LLC20183—
+12K261481Pangea Femur Reconstruction SystemStryker GmbH20260—
+12K252246Leforte MMF SystemJeil Medical Corporation20260—
+12K251732Wrist Fracture SystemMet One Technologies, LLC20260—
+12K253640T2 Alpha Femur Retrograde Nailing System; Pangea Femur Reconstruction SystemStryker GmbH20261—
+12K250163T2 Alpha Femur Retrograde Nailing SystemStryker GmbH20252—
+12K242864ROSA® Knee SystemOrthosoft Inc. (d/b/a) Zimmer CAS20241—
+12K242445Pangea Platform; Pangea Femur Plating System; Pangea Humerus Plating System; Pangea…Stryker GmbH20240—
+12K241582Aplio i900/i800/i700 Diagnostic Ultrasound System, Software V7.0 (TUS-AI900, TUS-AI800…Canon Medical Systems Corporation20240—
+12K241031TMINI Miniature Robotic System (TMINI 1.1)THINK Surgical, Inc.20248—
+12K233195Aplio i900, Aplio i800 and Aplio i700 Software V8.1 Diagnostic Ultrasound SystemCanon Medical Systems Corporation20243—
+12K231231MR Safety and Compatibility Testing and Labeling for Paragon 28 Orthopedic Fixation…Paragon 28, Inc.20231—
+12K221362Omni Foot and Ankle Plating SystemExremity Medical, LLC20220—
+12K201022Real Intelligence Cori (Cori)Blue Belt Technologies, Inc.202013—
+12K193614FINE Osteotomy around the kneeBodycad Laboratories, Inc.20204—
+12K193120Real Intelligence CoriBlue Belt Technologies, Inc.202014—
+12K192163TTC Phantom® Intramedullary Nail SystemParagon 28, Inc.20206—
+12K192592Axis Plating SystemExtremity Medical, LLC20190—
+12K191782TTC Phantom Intramedullary Nail SystemParagon 28, Inc.20196—
+13K251314Rosa® Knee SystemOrthosoft Inc. (d/b/a) Zimmer CAS20250—
+13K251850Phantom® Hindfoot TTC/TC Nail SystemParagon 28, Inc.20251—
+13K242808Aplio i900/i800/i700 Diagnostic Ultrasound System, Software V8.5Canon Medical Systems Corporation20252—
+13K242264TMINI Miniature Robotic SystemTHINK Surgical, Inc.20247—
+13K241262Baby Gorilla/Gorilla Plating System; Monster Screw SystemParagon 28, Inc.20240—