510(k) Report

Devices descending from K010612

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

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+7K170078Medisono Color Doppler Ultrasound System, models P11 Portable, P11 EXPERT Portable, P12…Medisono, LLC20170—
+7K170581Mako Total Knee ApplicationMako Surgical Corp.2017381
+7K170977SURESHOT Distal Targeting System V4.0 Trauma InterfaceSmith & Nephew, Inc.20170—
+7K163690DC-70/DC-70T /DC-70 Pro/DC-70 Exp/DC-75/DC-78/DC-70S Diagnostic Ultrasound SystemShenzhen Mindray Bio-Medical Electronics Co., Ltd.20179—
+7K170277DC-8/DC-8 PRO/DC-8 CV/DC-8 EXP/DC-8S Diagnostic Ultrasound SystemShenzhen Mindray Bio-Medical Electronics Co., Ltd.201720—
+7K162364Intellijoint HIP Generation 2A SystemIntellijoint Surgical, Inc.20177—
+7K163020Xperius Ultrasound SystemPhilips Health Care201611
+7K161439E-CUBE 11Alpinion Medical Systems Co., Ltd.201612—
+7K162329CX50 Diagnostic Ultrasound System, Sparq Diagnostic Ultrasound SystemPhilips Health Care2016273
+7K160914sterEOS WorkstationEos Imaging, Inc.20168—
+7K153424E-CUBE i7Alpinion Medical Systems Co., Ltd.201614—
+7K153647TSolution One w/ACG+ Surgical SystemTHINK Surgical, Inc.20168—
+7K152041Renaissance X SystemMazor Robotics, Ltd.201520—
+7K152976VLP Mini-Mod Talus PlatesSmith & Nephew, Inc.20158—
+7K152983FUJIFILM SonoSite iViz Ultrasound SystemFUJIFILM Sonosite, Inc.20155—
+7K152899Philips Lumify Diagnostic Ultrasound SystemPhilips Healthcare, Inc.2015794
+7K152574NavioBlue Belt Technologies, Inc.201519—
+7K152396S12 Digital Color Doppler Ultrasound SystemSonoscape Medical Corp.20151—
+7K152164S8 Exp/S9 Pro Portable Digital Color Doppler Ultrasound SystemSonoscape Medical Corp.20153—
+7K152165S9 Portable Digital Color Doppler Ultrasound SystemSonoscape Medical Corp.201502
+7K150547.decimal Astroid Dosimetry App.Decimal, Inc.20150—
+7K150045S30/S40 Digital Color Doppler Ultraound SystemSonoscape Company Limited201517—
+7K140167Renaissance X SystemMazor Robotics, Ltd.201421—
+7K141369Visiq Diagnostic Ultra Sound SystemPhilips Ultrasound, Inc.20140—
+7K140792Salvation 3DI Plating SystemWrightmedicaltechnologyinc201421
+7K140187Ray StationRaysearch Laboratories AB2014191
+7K140408Salvation Osteopenic ScrewWrightmedicaltechnologyinc20141—
+7K133930Flower Rear Foot Plating Set, Flower Calcaneus Planting Set, Flower Rearfoot Plating SetFlower Orthopedics Corporation201406
+7K123347Normed Ankle Fix System 4.0 and Normed Ankle Fix Plus System 4.0Normed Medizin-Technik GmbH201322
+7K121425Ortholoc 3DI Ankle Fusion Plating SystemWrightmedicaltechnologyinc201253—
+7K120667VLP 2.7MM Extra Large Percutaneous Calcaneus Plate, Peri-Loc 3.5MM Anterior Ankle Fusion…Smith & Nephew, Inc.20129—
+8K261852OTS HipOrtoma AB20260—
+8K253216IntraOp Alignment System; CONTOUR3D Bending SystemAlphatec Spine, Inc.20260—
+8K253050RadOncAIInformai20260—
+8K260077OrthoGrid Hip AI® 4.0OrthoGrid Systems, Inc.20260—
+8K260321HipGuide (V 1.0.0.0)Orthopedic Driven Imaging, LLC20260—
+8K260274Airlock® Ankle Plating SystemNovastep SAS20260—
+8K253713Arthrex Variable Angle (VA) Proximal Tibia Plating SystemArthrex, Inc.20260—
+8K252841Real Intelligence™ Cori™ XT (Cori XT)Blue Belt Technologies, Inc.20250—
+8K252665brAIn™ Shoulder PositioningAvatar Medical20250—
+8K252476Viewer (5.4); Elements Viewer; Mixed Reality Viewer; Smart Layout; Elements Viewer Smart…Brainlab AG20250—
+8K252214AIAS CephalonMetamorphosis GmbH20250—
+8K250064Dose+ (1.0)Mvision AI OY20250—
+8K252019CurvaFix Low Profile SystemCurvafix, Inc.20250—
+8K250290SurgiTwinTwinsight20250—
+8K243963Pediatric Plating Platform HipOrthoPediatrics Corp.20250—
+8K250030Flash Ultrasound System 5100 Point of CarePhilips Ultrasound, LLC202505
+8K242748OncospaceOncospace, Inc.20250—
+8K243292brAIn™ Shoulder PositioningAvatar Medical20250—
+8K250042PeekMed webPeek Health, S.A.20254—
+8K242161Radlink GPS Pro ImagingRadlink, Inc.20250—
+8K242616Lantern® HipOrthalign, Inc.20241—
+8K233816REDEMPTION Charcot Plating SystemVilex, LLC20240—
+8K240582VEA Align; spineEOSEos Imaging20244—
+8K240113CORIOGRAPH Knee Pre-Op PlanSmith & Nephew, Inc.20242—
+8K233199ROSA® Shoulder SystemOrthosoft Inc (D/B/A Zimmer Cas)20243—
+8K233299ExactechGPS® SystemBlue Ortho20240—
+8K233396Cannulated Screw SystemSmith & Nephew, Inc.20230—
+8K233017TM Plating SystemTyber Medical, LLC20231—
+8K2301796440 MyLabX90Esaote, S.p.A.202341
+8K232533ROSA Partial Knee SystemOrthosoft D/B/A Zimmer Cas20230—
+8K232521ExactechGPS® Total Ankle ApplicationBlue Ortho20230—
+8K231963Real Intelligence™ Cori™Blue Belt Technologies, Inc.202342
+8K230876RI.KNEE Adjustable Tibia Cut GuideEnztec Limited20230—
+8K230904Arthrex Virtual Implant Positioning (VIP) SystemArthrex, Inc.20231—
+8K223771Lumify Diagnostic Ultrasound SystemPhilips Ultrasound202322
+8K222665Medline UNITE® Ankle Fusion Plating SystemMedline Industries, Inc.20230—
+8K223804PercuNav Image Fusion and Interventional Navigation SystemPhilips Ultrasound, LLC20230—
+8K220169SonoMe Wireless Probe Type Ultrasound Scanner (Model: 5C, 5CB, H5C, 10L, 14L, 10LB…Bionet Co., Ltd.20220—
+8K221432Customize3D-Side S.A.20220—
+8K212040RI.Hip ModelerBlue Belt Technologies, Inc.20223—
+8K213523X-CUBE i8, X-CUBE i9Alpinion Medical Systems Co., Ltd.20220—
+8K212005UNiD Spine AnalyzerMedicrea International, Inc.202221
+8K213069CoLink NeoFuse Plating SystemIn2bones USA, LLC20211—
+8K212640Stratum® Ankle Fusion Plating SystemNextremity Solutions, Inc.20210—
+8K210157SOLE Medial Column Fusion PlateOrthofix Srl20210—
+8K203751OMNIVision systemCorin USA20210—
+8K203205Navigated Spine InstrumentsStryker Spine20218—
+8K203479ExtremiLOCK Lateral Ankle Fusion PlatesOsteomed20210—
+8K202749ADAPT for Gamma3Stryker GmbH20200—
+8K202307Activ FuseNewclip Technics20200—
+8K201188Clear Guide SCENERGYClear Guide Medical20201—
+8K201898Clear Guide SCENERGYClear Guide Medical20200—
+8K193515Mako Total Knee ApplicationMako Surgical Corp.202016
+8K200449X-Cube 90Alpinion Medical Systems Co., Ltd.20204—
+8K200450X-Cube 70Alpinion Medical Systems Co., Ltd.20204—
+8K201633Terason uSmart 3200T Plus Ultrasound SystemTeratech Corporation20200—
+8K193094Naviswiss Hip Navigation SystemNaviswiss AG20201—
+8K201012EPIQ Diagnostic Ultrasound System Series, Affiniti Diagnostic Ultrasound System Series…Philips Ultrasound, Inc.2020185
+8K192656Optimized Positioning System (OPS) InsightCorin USA20203—
+8K200642OrthAlign Plus SystemOrthalign, Inc.20200—
+8K200339HS40 Diagnostic Ultrasound SystemSamsung Medison Co., Ltd.20208—
+8K193128Mako Total Hip ApplicationMako Surgical Corp.20203—
+8K1921576450 Ultrasound systemEsaote, S.p.A.20194—
+8K191007Aixplorer MACH 30, Aixplorer MACH 20 Ultrasound Diagnostic SystemsSupersonic Imagine20195—
+8K192254InnoSight Diagnostic Ultrasound SystemQisda Corporation20190—
+8K191467Aplio i900/i800/i700/i600 Diagnostic Ultrasound System, V4.0Canon Medical Systems Corporation20199—
+8K182991EPIC Extremity Fusion Plate SystemEpic Extremity, LLC20190—
+8K181637DC-70/DC-70T/DC-70 Pro/DC-70 Exp/DC-75/DC-78/DC-70S Diagnostic Ultrasound SystemShenzhen Mindray Bio-Medical Electronics Co., Ltd.20198—
+8K182845minisonoAlpinion Medical Systems Co., Ltd.20180—