510(k) Report

Devices descending from K010612

838 later devices reach Vectorvision Knee through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+11K231231MR Safety and Compatibility Testing and Labeling for Paragon 28 Orthopedic Fixation…Paragon 28, Inc.20231—
+11K232802TMINI™ Miniature Robotic SystemTHINK Surgical, Inc.20239—
+11K230567OptiVu™ ROSA® MxROrthosoft Inc (D/B/A Zimmer Cas)20230—
+11K223564X-Cube 50, X-Cube 60Alpinion Medical Systems Co., Ltd.20230—
+11K230064Mazor X System (Mazor X Stealth Edition)Mazor Robotics, Ltd.202332
+11K220068Butterfly iQ/iQ+ Ultrasound SystemButterfly Network, Inc.20232—
+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—
+11K221496Consona N6, Consona N6 Pro, Consona N6 Super, Consona AR, Consona N6S, Consona AE…Shenzhen Mindray Bio-Medical Electronics Co., Ltd.20220—
+11K221300Consona N9, Consona N9 Pro, Consona N9 Super, Consona Nova, Consona N9S, Consona NI…Shenzhen Mindray Bio-Medical Electronics Co., Ltd.20223—
+11K221089P12 Elite Series Digital Color Doppler Ultrasound SystemSonoscape Medical Corp.20220—
+11K221140P20 Elite Series Digital Color Doppler Ultrasound SystemSonoscape Medical Corp.20220—
+11K221362Omni Foot and Ankle Plating SystemExremity Medical, LLC20220—
+11K212960Aplio a550, Aplio a450, and Aplio a, Diagnostic Ultrasound System, Software V6.5Canon Medical Systems Corporation202201
+11K210432LELTEK Ultrasound Imaging System (Model: LU700 Series)Leltek, Inc.20218—
+11K212704Philips EPIQ Diagnostic Ultrasound System, Philips Affiniti Diagnostic Ultrasound SystemPhilips Medical Systems20212—
+11K211527Exo IrisExo Imaging, Inc.20211—
+11K211337DC-70/DC-70T/DC-70 Pro/DC-70 Exp/DC-75/DC-78/DC-70S Diagnostic Ultrasound SystemShenzhen Mindray Bio-Medical Electronics Co., Ltd.20210—
+11K211441Navigated Anterolateral Disc Prep InstrumentsMedtronic Sofamor Danek USA, Inc.20219—
+11K202160Sonosite PX Ultrasound System, Sonosite SII Ultrasound System, Sonosite iViz Ultrasound…FUJIFILM Sonosite, Inc.20200—
+11K201059S60 Elite Series/S70 Series Digital Color Doppler Ultrasound SystemSonoscape Medical Corp.20204—
+11K201255TSolution® One Total Knee ApplicationTHINK Surgical, Inc.20203—
+11K193614FINE Osteotomy around the kneeBodycad Laboratories, Inc.20204—
+11K192163TTC Phantom® Intramedullary Nail SystemParagon 28, Inc.20206—
+11K193135TSolution One Total Knee ApplicationTHINK Surgical, Inc.20194—
+11K192592Axis Plating SystemExtremity Medical, LLC20190—
+11K191782TTC Phantom Intramedullary Nail SystemParagon 28, Inc.20196—
+11K192107Clarius Ultrasound ScannerClarius Mobile Health Corp.201910—
+11K191223NAVIOBlue Belt Technologies, Inc.201915—
+11K172993P20 Series Digital Color Doppler Ultrasound SystemSonoscape Medical Corp.20171—
+11K173058P10 Series Digital Color Doppler Ultrasound SystemSonoscape Medical Corp.20171—
+11K170750RT Elements, Cranial SRS, Spine SRS, Multiple Brain Mets SRS, RT QA, Adaptive Hybrid…Brainlab AG201701
+11K171536RayStationRaySearch Laboratories AB (PUBL)2017136
+12K260011Foundation Surgical Navigated Lateral Disc Prep InstrumentsFoundation Surgical Group, Inc.20260—
+12K254099EVO Q30 Diagnostic Ultrasound System; EVO Q20 Diagnostic Ultrasound System; EVO Q10…Samsung Medison Co., Ltd.20261—
+12K251853Consona N5, Consona N5 Pro, Consona N5 Super, Consona N5 Exp, Consona ER, Consona N5S…Shenzhen Mindray Bio-Medical Electronics Co., Ltd.20251—
+12K251316Mazor X System / Mazor X Stealth EditionMazor Robotics, Ltd.20251—
+12K251192Diagnostic Ultrasound System (MX7); Diagnostic Ultrasound System (MX7T); Diagnostic…Shenzhen Mindray Bio-Medical Electronics Co., Ltd.20250—
+12K251455EPIQ Series Diagnostic Ultrasound System; Affiniti Series Diagnostic Ultrasound SystemPhilips Ultrasound, LLC20250—
+12K251850Phantom® Hindfoot TTC/TC Nail SystemParagon 28, Inc.20251—
+12K250886EPIQ Series Diagnostic Ultrasound Systems; Affiniti Series Diagnostic Ultrasound SystemsPhilips Ultrasound, LLC20250—
+12K243793EPIQ Series Diagnostic Ultrasound System; Affiniti Series Diagnostic Ultrasound SystemPhilips Ultrasound, LLC20250—
+12K250110Diagnostic Ultrasound System (MX6); Diagnostic Ultrasound System (MX6S); Diagnostic…Shenzhen Mindray Bio-Medical Electronics Co., Ltd.20250—
+12K251110EPIQ Series Diagnostic Ultrasound Systems; Affiniti Series Diagnostic Ultrasound SystemsPhilips Ultrasound, LLC20250—
+12K243794EPIQ Series Diagnostic Ultrasound System; Affiniti Series Diagnostic Ultrasound SystemPhilips Ultrasound, LLC20255—
+12K242020EPIQ Series Diagnostic Ultrasound System; Affiniti Series Diagnostic Ultrasound SystemPhilips Ultrasound, LLC20243—
+12K242864ROSA® Knee SystemOrthosoft Inc. (d/b/a) Zimmer CAS20241—
+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—
+12K241262Baby Gorilla/Gorilla Plating System; Monster Screw SystemParagon 28, Inc.20240—
+12K240625CORUS Navigation Access SystemProvidence Medical Technology, Inc.20244—
+12K233195Aplio i900, Aplio i800 and Aplio i700 Software V8.1 Diagnostic Ultrasound SystemCanon Medical Systems Corporation20243—
+12K232808Butterfly iQ3 Ultrasound SystemButterfly Network, Inc.20241—
+12K232345ATEC Posterior Navigated Disc Prep InstrumentsAlphatec Spine, Inc.20232—
+12K230716Robotic Graft Delivery InstrumentsMedtronic Sofamor Danek, Inc.20230—
+12K231190EPIQ Series Diagnostic Ultrasound SystemPhilips Ultrasound, LLC202314
+12K222596S90 Exp Series Digital Color Doppler Ultrasound SystemSonoscape Medical Corp.20233—
+12K222198Exo Iris (El2001)Exo Imaging, Inc.20220—
+12K222365Leltek Ultrasound Imaging System (Model: LU700 Series)Leltek, Inc.20227—
+12K211665SONON Ultrasound Imaging System, Model: SONON300CHealcerion Co., Ltd.20220—
+12K220490ImaCor Zura Handheld ZHH-010Imacor, Inc.202202
+12K211746Pocket Ultrasound SystemGuangdong Youkey Medical Co., Ltd.20221—
+12K213436Clarius Ultrasound ScannerClarius Mobile Health Corp.20212—
+12K211646FINE OsteotomyBodycad Laboratories, Inc.20213—
+12K211232Apache Ultrasound SystemAco Healthcare Co., Ltd.20210—
+12K203040TSolution One Total Knee ApplicationTHINK Surgical, Inc.20202—
+12K202074Apache Ultrasound System (Model C62)Compal Electronics, Inc.20200—
+12K201227Phantom® Hindfoot TTC/TC Nail SystemParagon 28, Inc.20205—
+12K201022Real Intelligence Cori (Cori)Blue Belt Technologies, Inc.202013—
+12K193120Real Intelligence CoriBlue Belt Technologies, Inc.202014—
+12K182648X5 Series Digital Color Doppler Ultrasound SystemSonoscape Medical Corp.20190—
+12K180379RayStation 7RaySearch Laboratories AB (PUBL)2018127
+13K263182EVO X30 Diagnostic Ultrasound System; EVO X20 Diagnostic Ultrasound System; EVO X10…Samsung Medison Co., Ltd.20260—
+13K254027Digital Color Doppler Ultrasound System (Marvo 95/Marvo 95 Elite/Marvo 90/Marvo 90…Sonoscape Medical Corp.20260—
+13K260667Alturion Series Diagnostic Ultrasound SystemPhilips Ultrasound, LLC20261—
+13K260680EPIQ Series Diagnostic Ultrasound Systems; Affiniti Series Diagnostic Ultrasound SystemsPhilips Ultrasound, LLC202601
+13K260329Ion-C Navigation InstrumentsSurGenTec, LLC20261—
+13K254028Digital Color Doppler Ultrasound System (Autra RS, Autra 90, Autra Senior, Autra CV…Sonoscape Medical Corp.20260—
+13K260846Diagnostic Ultrasound System (MU9);Diagnostic Ultrasound System (MU9S);Diagnostic…Shenzhen Mindray Bio-Medical Electronics Co., Ltd.20260—
+13K252148Butterfly Gestational Age ToolButterfly Network, Inc.20260—
+13K253595EPIQ Series Diagnostic Ultrasound System, Affiniti Series Diagnostic Ultrasound SystemPhilips Ultrasound, LLC20261—
+13K253591Phantom® Hindfoot TTC/TC Nail SystemParagon 28, Inc.20260—
+13K252597Valence Robotic Navigation System; Valence Robotic Navigation Instruments (For Use with…Alphatec Spine, Inc.20261—
+13K253381Stealth AXiS™ Surgical System with Stealth AXiS™ Spine clinical applicationMedtronic Navigation, Inc.20260—
+13K252498Digital Color Doppler Ultrasound System (X11 Exp/X11 Elite/X11 Pro/X11 Plus/X11…Sonoscape Medical Corp.20250—
+13K250791ASUS Ultrasound Imaging System (LU800 series)Asustek Computer, Inc.20250—
+13K251314Rosa® Knee SystemOrthosoft Inc. (d/b/a) Zimmer CAS20250—
+13K251060CORUS™ Navigation System-GXProvidence Medical Technology, Inc.20250—
+13K242808Aplio i900/i800/i700 Diagnostic Ultrasound System, Software V8.5Canon Medical Systems Corporation20252—
+13K250177EPIQ Series Diagnostic Ultrasound System; Affiniti Series Diagnostic Ultrasound SystemPhilips Ultrasound, LLC20252—
+13K243659FLASH™ Facet Fusion Instruments, IsoTis® Facet Fusion InstrumentsSeaSpine Orthopedics Corporation20250—
+13K242681NUSONO Handheld Ultrasound Scanner (NUSONO-C35); NUSONO Handheld Ultrasound Scanner…Nurodata, Inc.20251—
+13K241161Ultrasound Imaging System (LK128L); Ultrasound Imaging System (LK128LH); Ultrasound…Leltek, Inc.20243—
+13K242264TMINI Miniature Robotic SystemTHINK Surgical, Inc.20247—
+13K231930Digital Ultrasonic Diagnostic Imaging System (Model: F6)Guangdong Youkey Medical Co., Ltd.20240—
+13K233545EPIQ Series Diagnostic Ultrasound SystemPhilips Ultrasound, LLC202301
+13K231509Aco Apache Ultrasound SystemAco Healthcare Co., Ltd.20230—
+13K232704Clarius Ultrasound ScannerClarius Mobile Health Corp.20230—
+13K231314Fine Osteotomy™Bodycad Laboratories, Inc.20232—