510(k) Report

Devices descending from K012448

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

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K123307Nuvasive NVM5 SystemNuvasive, Inc.201333—
+1K090420Smith & Nephew Pigalileo Screw Targeting System V 1.0Smith & Nephew, Inc.200978—
+1K062358Modification to Vectorvision TraumaBrainlab AG200734—
+1K060727Vectorvision HipBrainlab AG200671—
+1K050651Medtronic Orthopaedic Trauma ApplicationMedtronic Navigation, Inc.20051—
+1K042512Vectorvision AclBrainlab AG200557—
+2K140400ES2 Neuromonitoring Accessory InstrumentsStryker Corporation20149—
+2K132694Nuvasive NVM5 SystemNu Vasive, Incorporated201424—
+2K130887S4C Navigation InstrumentsAesculap Implant System, Inc.201313—
+2K111843Acufex Director Application Anatomic Guide SystemSmith & Nephew Inc., Endoscopy Div.20110—
+2K110204Brainlab TraumaBrainlab AG201127—
+2K103400Fluoromap Software, 9 Fluorodisc (Belt), 12 Fluoro Disc (Belt), Close Tube ClipStryker Corporation20115—
+2K093206Orthomap 3D 1.1 ModuleStryker Corp.20100—
+2K093118Brainlab Knee ArthroscopyBrainlab AG20100—
+2K092497Smith & Nephew Pigalileo Screw Targeting System, Version 1.1Smith & Nephew, Inc.200977—
+2K083483Brainlab Hip Unlimited, CI Hip UnlimitedBrainlab AG200970—
+2K081386Model 6150 (MYLAB70) and Model 6100 (MYLAB90)Esaote, S.p.A.2008532
+3K221618Spine & Trauma Navigation, Spine Navigation, Navigation Software Spine & Trauma…Brainlab AG20226—
+3K182359HipCheckStryker Corp.20181—
+3K181890Brainlab Compatible K2M Navigation InstrumentsK2m201811—
+3K173946ADAPT for Gamma3Stryker GmbH20182—
+3K180277Smith & Nephew SURESHOT Distal Targeting System V4.0 TargeterSmith & Nephew, Inc.20180—
+3K171807ES2 Neuromonitoring Accessory InstrumentsStryker Corporation20177—
+3K170280Smith & Nephew SURESHOT Distal Targeting System V4.0Smith & Nephew, Inc.20170—
+3K153700Aesculap (R) Implant Systems (AIS) S4 Navigation InstrumentsAesculap Implant Systems, LLC20160—
+3K142438Nerve Monitoring Cable SystemPioneer Surgical Technology, Inc. (Rti Surgical, Inc.)20154—
+3K141968Nuvasive NVM5 SystemNuvasive, Inc.201423—
+3K142008Mylabseven, MylabalphaEsaote, S.p.A.2014193
+3K1339056200 / 6250 Ultrasound SystemEsaote, S.p.A.201434—
+3K130748Smith & Nephew Sureshot Distal Targeting System V3.0Smith & Nephew, Inc.20131—
+3K122011Navigation Software Hip-Universal; Navigation Software Hip THR-AesculapBrainlab AG201251
+3K110021Dash HipBrainlab AG201147—
+3K110670VLP Foot Talus Plates, VLP Percutaneous Calcaneus Plates and Misc VLP Bone Screws…Smith & Nephew, Inc.201169—
+3K110240Smith & Nephew, Inc. Sureshot Distal Targeting System V2.1Smith & Nephew, Inc.20112—
+3K1031526250 Ultrasound SytemsEsaote, S.p.A.201135—
+3K102967Smith & Nephew, Inc. Sureshot Distal Targeting System V2.0.2Smith & Newphew, Inc.20103—
+3K100931Mylabtwice, Model 6200Esaote, S.p.A.201046—
+3K100107Smith & Nephew Sureshot Distal Targeting System V2.0Smith & Nephew, Inc.2010751
+3K091009MY LABS25 Gold/MYLAB30 Gold Cardiovascular Model 7340, MY LAB70/MY LAB70XVISION/MYLAB60…Esaote, S.p.A.200951—
+4K262257Spine Planning (3.0); Spine & Trauma Navigation; Alignment System SpineBrainlab SE20260—
+4K252562Spine & Trauma Navigation InstrumentsBrainlab AG20250—
+4K242569Mixed Reality Spine NavigationBrainlab AG20250—
+4K241893CROSSNAV Navigation Enabled Instruments and UNAS Navigation ArraysMedos International SARL20241—
+4K240701Drill Guide; Drill Bit; Spine & Trauma NavigationBrainlab AG20240—
+4K230045HipCheckStryker Corp.20230—
+4K213126Smith & Nephew, Inc. Plates and Screws Systems: EVOS, Peri-Loc, D-Rad, TC-100, VLP…Smith & Nephew, Inc.202221
+4K221821ATEC IOM Accessory InstrumentsAlphatec Spine, Inc.20221—
+4K210837Smith & Nephew Plates and ScrewsSmith & Nephew, Inc.202171
+4K201006K2M Navigation InstrumentsK2m, Inc.20200—
+4K193307HIP7Brainlab AG20200—
+4K192911Brainlab Compatible K2M Navigation InstrumentsK2m, Inc.20199—
+4K190163ALARA Neuro Access KitSurGenTec, LLC20192—
+4K182617ATEC IOM Accessory InstrumentsAlphatec Spine, Inc.20193—
+4K181848ADAPT for Gamma3, Gamma3Stryker GmbH20181—
+4K181449Ortoma Treatment Solution - OTSOrtoma AB20183—
+4K170977SURESHOT Distal Targeting System V4.0 Trauma InterfaceSmith & Nephew, Inc.20170—
+4K161999AixplorerSupersonic Imagine201620—
+4K161168MyLabSix Ultrasound SystemEsaote Europe B.V.20161—
+4K1613596400 Ultrasound System,7400 Ultrasound System, 7410 Ultrasound SystemEsaote, S.p.A.201645
+4K1532776200 Ultrasound System and 6250 Ultrasound SystemEsaote, S.p.A.201612—
+4K152976VLP Mini-Mod Talus PlatesSmith & Nephew, Inc.20158—
+4K143641NuVasive NVM5 SystemNu Vasive, Incorporated2015221
+4K133759Intellijoint HipIntellijoint Surgical, Inc.201410—
+4K140331Orthalign Plus SystemOrthalign, Inc.201429—
+4K140792Salvation 3DI Plating SystemWrightmedicaltechnologyinc201421
+4K140408Salvation Osteopenic ScrewWrightmedicaltechnologyinc20141—
+4K140677MylabssognoEsaote, S.p.A.20140—
+4K133930Flower Rear Foot Plating Set, Flower Calcaneus Planting Set, Flower Rearfoot Plating SetFlower Orthopedics Corporation201406
+4K132466Mylabseven 6400, Mylabalpha 7400Esaote, S.p.A.201322—
+4K132231Mylabseven, MylabalphaEsaote, S.p.A.201322—
+4K123347Normed Ankle Fix System 4.0 and Normed Ankle Fix Plus System 4.0Normed Medizin-Technik GmbH201322
+4K121425Ortholoc 3DI Ankle Fusion Plating SystemWrightmedicaltechnologyinc201253—
+4K121384MylabsognoEsaote, S.p.A.201211
+4K120667VLP 2.7MM Extra Large Percutaneous Calcaneus Plate, Peri-Loc 3.5MM Anterior Ankle Fusion…Smith & Nephew, Inc.20129—
+4K111302Mylabseven, MylabalphaEsaote, S.p.A.201124—
+4K110688MylabgoldEsaote2011251
+5K262253Lantern Knee Navigation Unit (406000-03);Lantern Hip Navigation Unit (502000-03)Orthalign, Inc.20260—
+5K254157CROSSNAV Navigation Enabled Instruments for Disc Preparation and InterbodyMedos International SARL20260—
+5K260274Airlock® Ankle Plating SystemNovastep SAS20260—
+5K253713Arthrex Variable Angle (VA) Proximal Tibia Plating SystemArthrex, Inc.20260—
+5K252019CurvaFix Low Profile SystemCurvafix, Inc.20250—
+5K243963Pediatric Plating Platform HipOrthoPediatrics Corp.20250—
+5K243945ALARA BMA Neuro Access Kit (ALARA BMAN and ALARA BMAC Kit)SurGenTec, LLC20250—
+5K233816REDEMPTION Charcot Plating SystemVilex, LLC20240—
+5K240664ALARA BMA Neuro Access Kit (ALARA BMAN and ALARA BMAC Kit)SurGenTec, LLC20241—
+5K232140OTS HipOrtoma AB202421
+5K233396Cannulated Screw SystemSmith & Nephew, Inc.20230—
+5K233017TM Plating SystemTyber Medical, LLC20231—
+5K223765ATEC Lateral Navigation InstrumentsAlphatec Spine, Inc.202302
+5K222665Medline UNITE® Ankle Fusion Plating SystemMedline Industries, Inc.20230—
+5K213069CoLink NeoFuse Plating SystemIn2bones USA, LLC20211—
+5K212640Stratum® Ankle Fusion Plating SystemNextremity Solutions, Inc.20210—
+5K210157SOLE Medial Column Fusion PlateOrthofix Srl20210—
+5K203205Navigated Spine InstrumentsStryker Spine20218—
+5K203479ExtremiLOCK Lateral Ankle Fusion PlatesOsteomed20210—
+5K202749ADAPT for Gamma3Stryker GmbH20200—
+5K202307Activ FuseNewclip Technics20200—
+5K191723ATEC IOM Accessory InstrumentsAlphatec Spine, Inc.20192—
+5K182524GALILEO Spine Alignment Monitoring SystemMiRus, LLC20190—
+5K1910727410 Ultrasound System (MyLabSigma)Esaote, S.p.A.20190—