510(k) Report

Devices descending from K010602

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

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+8K202307Activ FuseNewclip Technics20200—
+8K201188Clear Guide SCENERGYClear Guide Medical20201—
+8K201898Clear Guide SCENERGYClear Guide Medical20200—
+8K200449X-Cube 90Alpinion Medical Systems Co., Ltd.20204—
+8K200450X-Cube 70Alpinion Medical Systems Co., Ltd.20204—
+8K201633Terason uSmart 3200T Plus Ultrasound SystemTeratech Corporation20200—
+8K201012EPIQ Diagnostic Ultrasound System Series, Affiniti Diagnostic Ultrasound System Series…Philips Ultrasound, Inc.2020185
+8K192656Optimized Positioning System (OPS) InsightCorin USA20203—
+8K200339HS40 Diagnostic Ultrasound SystemSamsung Medison Co., Ltd.20208—
+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—
+8K1831916420 Ultrasound SystemEsaote, S.p.A.20180—
+8K182427Aplio a550 and a450, Software V2.8 Diagnostic Ultrasound SystemCanon Medical Systems Corporation20184—
+8K182077Mazor X System (Mazor X Stealth Edition)Mazor Robotics, Ltd.2018162
+8K182679Aplio i900/i800/i700/i600 Diagnostic Ultrasound System, V3.1Canon Medical Systems Corporation201810—
+8K182529Xperius Ultrasound SystemPhilips Ultrasound, Inc.20180—
+8K182148SILVERBACK Gorilla Plating SystemParagon 28, Inc.20183—
+8K181485EPIQ , EPIQ 5, EPIQ 7, Affiniti 30, Affiniti 50 and Affiniti 70 Diagnostic Ultrasound…Philips Ultrasound, Inc.20182724
+8K172346sterEOS WorkstationEos Imaging201871
+8K173940Astroid Planning App.Decimal, LLC20180—
+8K173471DC-80/DC-80 PRO/DC-80 EXP/DC-80S/DC-85 DiagnosticShenzhen Mindray Bio-Medical Electronics Co., Ltd.20181—
+8K172056InnoSight Diagnostic Ultrasound SystemQisda Corporation20172—
+8K173121Ankle Fusion Plating SystemIn2bones Sas20172—
+8K171891ZS3 Ultrasound System, z.one pro Ultrasound SystemShenzhen Mindray Bio-Medical Electronics Co., Ltd.20174—
+8K171034M9 Diagnostic Ultrasound System, M9T Diagnostic Ultrasound System, M9CV Diagnostic…Shenzhen Mindray Bio-Medical Electronics Co., Ltd.201712—
+8K163650ORTHOLOC® 3Di Ankle Fusion Plating System Line ExtensionWrightmedicaltechnologyinc201712—
+8K163443Interson USB Ultrasound SystemInterson Corporation20173—
+8K170430TSolution One Surgical System Model 210THINK Surgical, Inc.20176—
+8K163138Clarius Ultrasound SystemClarius Mobile Health Corp.201628—
+8K162549Lumify Ultrasound SystemPhilips Health Care2016436
+8K161119SonoSite iViz Ultrasound SystemFUJIFILM Sonosite, Inc.20164—
+8K160258X5 Digital Color Doppler Ultrasound SystemSonoscape Medical Corp.20162—
+8K160191Align Anterior Ankle Fusion PlateExtremity Medical, LLC20165—
+8K160420SpeqTSignostics Limited20161—
+8K152854S50 Digital Color Doppler Ultrasound SystemSonoscape Medical Corp.201616—
+8K141860RaystationRaysearch Laboratories AB2014175
+8K140397Paralock Plating System / Tuffnek ScrewParagon 28201431—
+9K261272ePascal S/ ePascal SOR/ ePascal S5/ ePascal SA/ ePascal SE/ ePascal 80Elite/ ePascal 80/…Esonic Technology (Wuhan) Co., Ltd.20260—
+9K261207Exalta Proximal Tibia Plating SystemTyber Medical, LLC20260—
+9K252558Lumify Diagnostic Ultrasound SystemPhilips Ultrasound, LLC20260—
+9K260546Q Pedicle InstrumentsK2m, Inc.20260—
+9K252873Q Interbody InstrumentsK2m, Inc.20260—
+9K252871Spine Guidance 5.3 Software; Q Interbody Instruments; Elite Q Attachments; Elite Cutting…Stryker Leibinger GmbH & Co KG20261—
+9K252557Lumify Diagnostic Ultrasound SystemPhilips Ultrasound, LLC20250—
+9K252103Acorn 3D Software (AC-SEG-4009); Acorn 3DP Model (AC-101-XX)Mighty Oak Medical20251—
+9K251747VEA Align; spineEOSEos Imaging20251—
+9K251629UNiD™ Spine AnalyzerMedicrea International S.A.S. (Medtronic)20251—
+9K251096PeekMed webPeek Health, S.A.20253—
+9K2432536600 Ultrasound System (MyLabA50); 6600 Ultrasound System (MyLabA70)Esaote, S.p.A.20252—
+9K2416716450 Ultrasound System (MyLabE80); 6450 Ultrasound System (MyLabE85)Esaote, S.p.A.20252—
+9K243447Rapid Surgical Plan (RSP-SW-001)Navbit Pty, Ltd.20240—
+9K242272CORIOGRAPH Pre-Op Planning and Modeling ServicesBlue Belt Technologies, Inc.20241—
+9K241387CoLink NeoFuse MIS Plating System (see attached parts list)In2bones USA20240—
+9K241171Spine Guidance Software (Version 5.1); Consolidated Operating Room Equipment (CORE) 2…Stryker Leibinger GmbH & Co KG20244—
+9K240139Real Intelligence™ CORI™Blue Belt Technologies, Inc.202431
+9K234030Clear Guide SCENERGYClear Guide Medical20240—
+9K231917VEA AlignEos Imaging20245—
+9K233734Interson USB Ultrasound SystemInterson Corporation20230—
+9K231354Pocket Ultrasound System (C10)Beijing Konted Medical Technology Co.,Ltd20232—
+9K232500Lumify Diagnostic Ultrasound SystemPhilips Ultrasound202301
+9K230066Carnation series Diagnostic Ultrasound SystemShenzhen Wisonic Medical Technology Co., Ltd.20230—
+9K2120216430 MyLabX75, 6430 MyLab XPro75Esaote, S.p.A.20210—
+9K211597EPIQ Series Diagnostic Ultrasound System, Affiniti Series Diagnostic Ultrasound SystemPhilips Medical Systems202117—
+9K211300X-CUBE 90Alpinion Medical Systems Co., Ltd.20213—
+9K211299X-CUBE 70Alpinion Medical Systems Co., Ltd.20213—
+9K210713HM70 EVO Diagnostic Ultrasound SystemSamsung Medison Co., Ltd.20214—
+9K210653ONE Planner HipOrthosoft D/B/A Zimmer Cas20210—
+9K203645Aixplorer MACH30/ SUPERSONIC MACH30, Aixplorer MACH20/ SUPERSONIC MACH20, SUPERSONIC…Supersonic Imagine20212—
+9K210416M9/M9CV/M9T/M8 Elite/M10/M10CV/Crius M10/M11/M11CV/Crius M11/Operus M11/M9 Premium…Shenzhen Mindray Bio-Medical Electronics Co., Ltd.20212—
+9K210426HS40 Diagnostic Ultrasound SystemSamsung Medison Co., Ltd.20211—
+9K202455Aixplorer®MACH20, Aixplorer®MACH30, Supersonic MACH40, Supersonic MACH30 & Supersoinc…Supersonic Imagine20200—
+9K202805Optimized Positioning System (OPS) InsightCorin USA20200—
+9K202556HS30 Diagnostic Ultrasound SystemSamsung Medison Co., Ltd.20200—
+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—
+9K193545Corin Optimized Positioning System (OPS) FemoralCorin USA20200—
+9K193042Optimized Positioning System (OPS) ReViewCorin USA20200—
+9K200398AxSOS 3 AF System and AxSOS 3 Ti SystemStryker GmbH20209—
+9K200935Mazor XMazor Robotics, Ltd.202015—
+9K200762CoLink Cfx Plating SystemIn2bones USA, LLC20201—
+9K200001MX7/ MX7T/ Vaus7/ Zeus Diagnostic Ultrasound System, ME7/ Anesus ME7/ Anesus ME7T…Shenzhen Mindray Bio-Medical Electronics Co., Ltd.20208—
+9K200304EPIQ Diagnostic Ultrasound SystemPhilips Ultrasound, Inc.2020243
+9K192170VistaScan USB Ultrasound Imaging SystemEmagine Solutions Technology, LLC20200—
+9K192410ZS3 and z.one pro Ultrasound SystemsShenzhen Mindray Bio-Medical Electronics Co., Ltd.20193—
+9K192152DC-80/DC-80 PRO/DC-80 EXP/DC-80S/DC-85/DC-86/DC-86S/DC-89/DC-TV/DC-TQ Diagnostic…Shenzhen Mindray Bio-Medical Electronics Co., Ltd.20196—
+9K192573Dolphin Medical Imaging USB Ultrasound SystemDolphin Medical Imaging, LLC20190—
+9K191369TSolution One Total Knee ApplicationTHINK Surgical, Inc.20195—
+9K191663Aplio a550, Aplio a450 and Aplio a, Diagnostic Ultrasound System, V4.0Canon Medical Systems Corporation20193—
+9K192226Lumify Diagnostic Ultrasound SystemPhilips Health Care2019315
+9K190206DC-90/DC-90S/DC-90Q/DC-95/DC-95S/DC-88/DC-88S/DC-80A/DC-80A Exp/DC-80A…Shenzhen Mindray Bio-Medical Electronics Co., Ltd.20190—
+9K182857EPIQ Diagnostic Ultrasound System, EPIQ 5 Diagnostic Ultrasound System, EPIQ 7…Philips Ultrasound, Inc.20181923
+9K181313BenQ Diagnostic Ultrasound SystemQisda Corporation20181—
+9K181574UscanEchoNous, Inc.20180—
+9K181067AlignX Ankle Fusion SystemExtremity Medical, LLC20184—
+9K172973Life Spine Foot and Ankle Plating SystemLife Spine, Inc.20170—