510(k) Report

Devices descending from K012448

251 later devices reach Vectorvision Trauma through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+5K1909896400 Ultrasound System (MyLabX6, MyLabX7)Esaote, S.p.A.20190—
+5K1904477400 Ultrasound SystemsNavigant Consulting - on Behalf of Esaote S.P.A.20190—
+5K182991EPIC Extremity Fusion Plate SystemEpic Extremity, LLC20190—
+5K1831916420 Ultrasound SystemEsaote, S.p.A.20180—
+5K182148SILVERBACK Gorilla Plating SystemParagon 28, Inc.20183—
+5K173121Ankle Fusion Plating SystemIn2bones Sas20172—
+5K171105AIXPLORER® & AIXPLORER® Ultimate Ultrasound SystemsSupersonic Imagine201719—
+5K163119NaviSuite SSI EditionMedcom GmbH20171—
+5K163650ORTHOLOC® 3Di Ankle Fusion Plating System Line ExtensionWrightmedicaltechnologyinc201712—
+5K1630826200 Ultrasound System and 6250 Ultrasound SystemEsaote, S.p.A.201792
+5K162199Cascade IOMAX Intraoperative MonitorCadwell Industries, Inc.201773
+5K162290MyLabSix CrystaLineEsaote, S.p.A.20160—
+5K160191Align Anterior Ankle Fusion PlateExtremity Medical, LLC20165—
+5K153237OrthAlign Plus SystemOrthalign, Inc.201618—
+5K152942NuVasiveNVM5 SystemNu Vasive, Incorporated201613—
+5K151364Intellijoint HIP (tm) SystemIntellijoint Surgical, Inc.20158—
+5K150741TSolution One w/ACG surgical SystemTHINK Surgical, Inc.20159—
+5K142077MylabgammaEsaote, S.p.A.201453
+5K141486Mylabsix Ultrasound SystemEsaote Europe B.V.20148—
+5K140397Paralock Plating System / Tuffnek ScrewParagon 28201431—
+6K263010ISIS Headboxes, ISIS Neurostimulator, ISIS Xpert Plus, ISIS Xpert, ISIS Xpressinomed Medizintechnik GmbH20260—
+6K261207Exalta Proximal Tibia Plating SystemTyber Medical, LLC20260—
+6K250086OTS HipOrtoma AB202511
+6K241387CoLink NeoFuse MIS Plating System (see attached parts list)In2bones USA20240—
+6K240662Spine Guidance Software (version 5.0); Xia 3/ Serrato Q Instruments; Everest Q…Stryker Leibinger GmbH & Co KG20247—
+6K230415Cadwell GuardianCadwell Industries, Inc.20230—
+6K212166ISIS Headboxes, ISIS Neurostimulator, ISIS Xpert Plus, ISIS Xpert, ISIS XpressInomed Medizintechnik GmbH20225—
+6K200398AxSOS 3 AF System and AxSOS 3 Ti SystemStryker GmbH20209—
+6K200762CoLink Cfx Plating SystemIn2bones USA, LLC20201—
+6K181466Cadwell Zenith SystemCadwell Industries, Inc.20180—
+6K181067AlignX Ankle Fusion SystemExtremity Medical, LLC20184—
+6K1732916440 Ultrasound SystemEsaote, S.p.A.20188—
+6K173021Aixplorer & Aixplorer Ultimate Ultrasound Diagnostic SystemsSupersonic Imagine201818—
+6K172973Life Spine Foot and Ankle Plating SystemLife Spine, Inc.20170—
+6K172886Breakaway Screw SystemParagon 2820174—
+6K172849Intellijoint HIP System (Cart), Intellijoint HIP System (Portable), Intellijoint HIP…Intellijoint Surgical, Inc.201711
+6K172260Omni Foot Plating SystemExtremity Medical, LLC20174—
+6K170841BiopSee, Mobile USMedcom GmbH20170—
+6K170693Phantom Small Bone Intramedullary Nail SystemParagon 28, Inc.20179—
+6K162647NuVasive NuvaLine Mobile AppNu Vasive, Incorporated20174—
+6K170214Additive Orthopaedics Locking Lattice PlateAdditive Orthopaedics, LLC20178—
+6K162313NuVasive Next Generation NVM5 SystemNu Vasive, Incorporated20177—
+6K162364Intellijoint HIP Generation 2A SystemIntellijoint Surgical, Inc.20177—
+6K163379KneeAlign 2 SystemOrthalign, Inc.20171—
+6K162962OrthAlign Plus SystemOrthalign, Inc.201715—
+6K153647TSolution One w/ACG+ Surgical SystemTHINK Surgical, Inc.20168—
+7K261852OTS HipOrtoma AB20260—
+7K260546Q Pedicle InstrumentsK2m, Inc.20260—
+7K252873Q Interbody InstrumentsK2m, Inc.20260—
+7K252871Spine Guidance 5.3 Software; Q Interbody Instruments; Elite Q Attachments; Elite Cutting…Stryker Leibinger GmbH & Co KG20261—
+7K241171Spine Guidance Software (Version 5.1); Consolidated Operating Room Equipment (CORE) 2…Stryker Leibinger GmbH & Co KG20244—
+7K233154SkyOPS™ Orthopedic Plate SystemSky Surgical, LLC20231—
+7K231887ARIX Ankle Distal Tibia SystemJeil Medical Corporation20231—
+7K2301796440 MyLabX90Esaote, S.p.A.202341
+7K233292ISIS Headboxes, ISIS Neurostimulator, ISIS Xpert Plus, ISIS Xpert, ISIS XpressInomed Medizintechnik GmbH20231—
+7K231262Pangea Femur Plating System, Pangea Fibula Plating System, Pangea Tibia Plating System…Stryker GmbH20234—
+7K231257Pangea Utility Plating System, Pangea PlatformStryker GmbH20231—
+7K222381PeriPRO™ Femur System, Variable Angle Fixation System, AxSOS 3Ti, Stryker Plating SystemStryker GmbH20238—
+7K211987ATEC Alignment AppAlphatec Spine, Inc.20212—
+7K212297Omni Foot and Ankle Plating SystemExtremity Medical, LLC20211—
+7K203751OMNIVision systemCorin USA20210—
+7K192653PerseusOrthokey Italia S.R.L.20200—
+7K200655FibroScan® 630Echosens20200—
+7K201149CoLink Plating SystemIn2bones USA, LLC20200—
+7K200892Harvey (R) Surgical AssistantOrthalign, Inc.202022
+7K193094Naviswiss Hip Navigation SystemNaviswiss AG20201—
+7K1921576450 Ultrasound systemEsaote, S.p.A.20194—
+7K192435NuVasive NuvaLineNu Vasive, Incorporated20190—
+7K182307Small Bone Phantom® Intramedullary Nail System; TTC Phantom® Intramedullary Nail SystemParagon 28, Inc.20198—
+7K183011Additive Orthopaedics Patient Specific 3D Locking Lattice PlatesAdditive Orthopaedics20195—
+7K180038NuVasive Pulse SystemNu Vasive, Incorporated20183—
+7K180572AIXPLORER MACH Ultrasound Diagnostic Systems Aixplorer Mach 30, Aixplorer Mach 20…Supersonic Imagine201816—
+7K180808Omni Foot Plating SystemExtremity Medical, LLC20183—
+7K173526SENTIO MMG Gen 2Medos International SARL20182—
+7K171525Intellijoint HIP Generation 2B SystemIntellijoint Surgical, Inc.20173—
+7K171780OrthAlign Plus SystemOrthalign, Inc.201712—
+7K162195TSolution One Cup1 Surgical SystemTHINK Surgical, Inc.20167—
+8K261481Pangea Femur Reconstruction SystemStryker GmbH20260—
+8K253507Packaged Assembly, Reusable Navigation Unit; Lantern ASC, Smart Pack kit, KneeOrthalign, Inc.20260—
+8K252246Leforte MMF SystemJeil Medical Corporation20260—
+8K253623Spine Guidance 5.4 Software; Spine Guidance 5.4 Upgrade; Spine Guidance 5.4 Update…Stryker Leibinger GmbH & Co KG20260—
+8K251732Wrist Fracture SystemMet One Technologies, LLC20260—
+8K253640T2 Alpha Femur Retrograde Nailing System; Pangea Femur Reconstruction SystemStryker GmbH20261—
+8K250163T2 Alpha Femur Retrograde Nailing SystemStryker GmbH20252—
+8K243636Neuralytix iD3 System (NTX-9001)Neuralytix, LLC20251—
+8K2432536600 Ultrasound System (MyLabA50); 6600 Ultrasound System (MyLabA70)Esaote, S.p.A.20252—
+8K2416716450 Ultrasound System (MyLabE80); 6450 Ultrasound System (MyLabE85)Esaote, S.p.A.20252—
+8K243958Consolidated Operating Room Equipment (CORE) 2 ConsoleStryker Instruments20250—
+8K242445Pangea Platform; Pangea Femur Plating System; Pangea Humerus Plating System; Pangea…Stryker GmbH20240—
+8K242616Lantern® HipOrthalign, Inc.20241—
+8K241517Q Guidance System; Mako Spine System;Stryker Leibinger GmbH & Co KG20242—
+8K240199IntraOp Alignment SystemAlphatec Spine, Inc.20241—
+8K231231MR Safety and Compatibility Testing and Labeling for Paragon 28 Orthopedic Fixation…Paragon 28, Inc.20231—
+8K223351Naviswiss KneeNaviswiss AG20230—
+8K221362Omni Foot and Ankle Plating SystemExremity Medical, LLC20220—
+8K2120216430 MyLabX75, 6430 MyLab XPro75Esaote, S.p.A.20210—
+8K210574NuVasive Pulse SystemNu Vasive, Incorporated202121
+8K200642OrthAlign Plus SystemOrthalign, Inc.20200—
+8K193614FINE Osteotomy around the kneeBodycad Laboratories, Inc.20204—
+8K192163TTC Phantom® Intramedullary Nail SystemParagon 28, Inc.20206—