510(k) Report

Devices descending from K010612

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

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+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—
+8K172301Mako Partial Knee ApplicationMako Surgical Corp.201716
+8K171525Intellijoint HIP Generation 2B SystemIntellijoint Surgical, Inc.20173—
+8K171891ZS3 Ultrasound System, z.one pro Ultrasound SystemShenzhen Mindray Bio-Medical Electronics Co., Ltd.20174—
+8K172219Mako Total Knee ApplicationMako Surgical Corp.201737—
+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—
+8K163138Clarius Ultrasound SystemClarius Mobile Health Corp.201628—
+8K162549Lumify Ultrasound SystemPhilips Health Care2016436
+8K162195TSolution One Cup1 Surgical SystemTHINK Surgical, Inc.20167—
+8K160537NavioBlue Belt Technologies, Inc.201618—
+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—
+9K260582ROSA® Shoulder SystemOrthosoft Inc. (d/b/a) Zimmer CAS20260—
+9K252558Lumify Diagnostic Ultrasound SystemPhilips Ultrasound, LLC20260—
+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—
+9K243751Mako Total Hip Application 5.0Mako Surgical Corp.20251—
+9K243447Rapid Surgical Plan (RSP-SW-001)Navbit Pty, Ltd.20240—
+9K242272CORIOGRAPH Pre-Op Planning and Modeling ServicesBlue Belt Technologies, Inc.20241—
+9K242373Mako Shoulder Application (1.0)Mako Surgical Corp.20240—
+9K241097Arthrex Virtual Implant Positioning (VIP) System SoftwareArthrex, Inc.20240—
+9K241387CoLink NeoFuse MIS Plating System (see attached parts list)In2bones USA20240—
+9K240662Spine Guidance Software (version 5.0); Xia 3/ Serrato Q Instruments; Everest Q…Stryker Leibinger GmbH & Co KG20247—
+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—
+9K220774RobPath® Total Hip ApplicationHangzhou Lancet Robotics Co., Ltd.20220—
+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—
+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—
+9K182964ROSA Knee SystemOrthosoft Inc (D/B/A Zimmer Cas)201929—
+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—
+9K172886Breakaway Screw SystemParagon 2820174—
+9K172260Omni Foot Plating SystemExtremity Medical, LLC20174—
+9K173138Biim Diagnostic Ultrasound SystemBiim Ultrasound AS20170—
+9K170085SONON Ultrasound Imaging System, Model: 300LHealcerion Co., Ltd.20174—
+9K172385Clarius Ultrasound SystemClarius Mobile Health Corp.201722—
+9K163510Poseidon Ultrasound SystemButterfly Network, Inc.201762
+9K170693Phantom Small Bone Intramedullary Nail SystemParagon 28, Inc.20179—
+9K170303E5 Series Digital Color Doppler Ultrasound SystemSonoscape Medical Corp.20170—
+9K170360NAVIOBlue Belt Technologies, Inc.201717—
+9K170214Additive Orthopaedics Locking Lattice PlateAdditive Orthopaedics, LLC20178—
+9K170430TSolution One Surgical System Model 210THINK Surgical, Inc.20176—