510(k) Report

Devices descending from K010602

715 later devices reach Vectorvision Hip through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+7K240199IntraOp Alignment SystemAlphatec Spine, Inc.20241—
+7K232759Viewer (5.4); Elements Viewer; Mixed Reality Viewer; Smart Layout; Elements Viewer Smart…Brainlab AG202411
+7K233172NextAR™ Spine PlatformMedacta International S.A.20241—
+7K240172Preview ShoulderGenesis Software Innovations20240—
+7K232320iSR`obot Mona Lisa 2.0Biobot Surgical Pte., Ltd.20230—
+7K232086spineEOSEos Imaging20235—
+7K231172ApolloKneeCorin U.S.A. Limited20230—
+7K222803OncospaceOncospace, Inc.20233—
+7K221911Vinno 6PRO, Vinno 6EXP, Vinno 5PRO, Vinno 5EXP, Vinno 3, Vinno 3PRO, Vinno 3EXPVinno Technology (Suzhou) Co.,Ltd20220—
+7K220774RobPath® Total Hip ApplicationHangzhou Lancet Robotics Co., Ltd.20220—
+7K213126Smith & Nephew, Inc. Plates and Screws Systems: EVOS, Peri-Loc, D-Rad, TC-100, VLP…Smith & Nephew, Inc.202221
+7K221224Real Intelligence CoriBlue Belt Technologies, Inc.20229—
+7K213779Customize3D-Side S.A.20221—
+7K210837Smith & Nephew Plates and ScrewsSmith & Nephew, Inc.202171
+7K203205Navigated Spine InstrumentsStryker Spine20218—
+7K202487HealthJOINTZebra Medical Vision, Ltd.20200—
+7K192653PerseusOrthokey Italia S.R.L.20200—
+7K200655FibroScan® 630Echosens20200—
+7K192914Stimuplex Onvision SystemPhilips Medical Systems Nederland B.V.20200—
+7K201053PercuNav Image Fusion and Interventional NavigationPhilips Ultrasound, Inc.20201—
+7K193510Terason uSmart3200T Ultrasound SystemTeratech Corporation20201—
+7K192435NuVasive NuvaLineNu Vasive, Incorporated20190—
+7K191055HS40 Diagnostic Ultrasound SystemSamsung Medison Co., Ltd.20199—
+7K190042Brainlab Elements Image Fusion AngioBrainlab AG20190—
+7K182594E-CUBE i7Alpinion Medical Systems Co., Ltd.20191—
+7K181617E-CUBE 8Alpinion Medical Systems Co., Ltd.20180—
+7K181277E-CUBE 12Alpinion Medical Systems Co., Ltd.20187—
+7K180572AIXPLORER MACH Ultrasound Diagnostic Systems Aixplorer Mach 30, Aixplorer Mach 20…Supersonic Imagine201816—
+7K180307Mazor XMazor Robotics, Ltd.201817—
+7K173390hipEOSOnefit Medical20188—
+7K180394BrightMatter Plan 1.6.0Synaptive Medical, Inc.20180—
+7K180091UNiD Spine AnalyzerMedicrea International20186—
+7K1732916440 Ultrasound SystemEsaote, S.p.A.20188—
+7K173090Aplio i900/i800/i700/i600 Diagnostic Ultrasound System, V2.4Toshibamedical Systems Corporation201821—
+7K172732E-CUBE 8Alpinion Medical Systems Co., Ltd.201711—
+7K171677Clear Guide SCENERGYClear Guide Medical20173—
+7K173247Surgical Planning Software version 1.1Ortho Kinematics, Inc.20170—
+7K171926C5 Diagnostic Ultrasound SystemGuangzhou Sonostar Technologies Co., Ltd.20171—
+7K172607Philips EPIQ 5 Diagnostic Ultrasound System, EPIQ 7 Diagnostic Ultrasound System…Philips Health Care20172831
+7K172522Mazor XMazor Robotics, Ltd.20170—
+7K172055DUS-7000 Digital Color Doppler Ultrasound SystemAdvanced Instrumentations, Inc.20170—
+7K170078Medisono Color Doppler Ultrasound System, models P11 Portable, P11 EXPERT Portable, P12…Medisono, LLC20170—
+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—
+7K163020Xperius Ultrasound SystemPhilips Health Care201611
+7K161439E-CUBE 11Alpinion Medical Systems Co., Ltd.201612—
+7K162195TSolution One Cup1 Surgical SystemTHINK Surgical, Inc.20167—
+7K162329CX50 Diagnostic Ultrasound System, Sparq Diagnostic Ultrasound SystemPhilips Health Care2016273
+7K160914sterEOS WorkstationEos Imaging, Inc.20168—
+7K153424E-CUBE i7Alpinion Medical Systems Co., Ltd.201614—
+7K152976VLP Mini-Mod Talus PlatesSmith & Nephew, Inc.20158—
+7K152983FUJIFILM SonoSite iViz Ultrasound SystemFUJIFILM Sonosite, Inc.20155—
+7K152899Philips Lumify Diagnostic Ultrasound SystemPhilips Healthcare, Inc.2015794
+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—
+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—
+8K253216IntraOp Alignment System; CONTOUR3D Bending SystemAlphatec Spine, Inc.20260—
+8K253050RadOncAIInformai20260—
+8K260274Airlock® Ankle Plating SystemNovastep SAS20260—
+8K253713Arthrex Variable Angle (VA) Proximal Tibia Plating SystemArthrex, Inc.20260—
+8K252476Viewer (5.4); Elements Viewer; Mixed Reality Viewer; Smart Layout; Elements Viewer Smart…Brainlab AG20250—
+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—
+8K250042PeekMed webPeek Health, S.A.20254—
+8K233816REDEMPTION Charcot Plating SystemVilex, LLC20240—
+8K240582VEA Align; spineEOSEos Imaging20244—
+8K240662Spine Guidance Software (version 5.0); Xia 3/ Serrato Q Instruments; Everest Q…Stryker Leibinger GmbH & Co KG20247—
+8K240113CORIOGRAPH Knee Pre-Op PlanSmith & Nephew, Inc.20242—
+8K233396Cannulated Screw SystemSmith & Nephew, Inc.20230—
+8K233017TM Plating SystemTyber Medical, LLC20231—
+8K2301796440 MyLabX90Esaote, S.p.A.202341
+8K231963Real Intelligence™ Cori™Blue Belt Technologies, Inc.202342
+8K230876RI.KNEE Adjustable Tibia Cut GuideEnztec Limited20230—
+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—
+8K203479ExtremiLOCK Lateral Ankle Fusion PlatesOsteomed20210—