510(k) Report

Devices descending from K042210

666 later devices reach MSD Silo Spinal System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+8K240526POWEReam Xia/SerratoStryker Instruments20240—
+8K240872Erisma® Deformity Spinal System; Erisma® Lp Spinal Fixation SystemClariance20241—
+8K233638VERZA™ High Speed DrillsGlobus Medical, Inc.20241—
+8K233684TriALTIS™ Spine SystemMedos International SARL20234—
+8K233078Posterior Cervical Spine SystemDouble Medical Technology, Inc.20231—
+8K232719ProMIS Extension Rod SystemPremia Spine, Ltd.20230—
+8K233443Vital™ Navigation SystemZimvie Spine (Zimmer Biomet Spine, Inc.)20230—
+8K231494CoreLink Robotic Navigation InstrumentsCorelink, LLC20230—
+8K231809Momentum® Posterior Spinal Fixation System with G21 V-STEADY Bone Cement; Momentum® MIS…Ulrich Medical USA20231—
+8K231658VEOS Spinal Fixation SystemSpineway20230—
+8K232044Invictus Robotic Navigation InstrumentsAlphatec Spine, Inc.20233—
+8K232275Invictus® Spinal Fixation SystemAlphatec Spine, Inc.202311—
+8K223558CUVIS-spineCurexo, Inc.20230—
+8K231199Solar Lumbar Interbody Fusion SystemDegen Medical20235—
+8K230721ATEC Lateral Plate SystemAlphatec Spine, Inc.20230—
+8K230565HILINE™ Fixation SystemGlobus Medical, Inc.20230—
+8K223765ATEC Lateral Navigation InstrumentsAlphatec Spine, Inc.202302
+8K223350Remi Robotic Navigation SystemFusion Robotics, LLC20230—
+8K223413Pisces™-SA STANDALONE ALIF Interbody SystemOsseus Fusion Systems20233—
+8K222614Zavation Spinal SystemZavation Medical Products, LLC20223—
+8K221403Cortera Spinal Fixation SystemSurgalign Spine Technologies202232
+8K213876Spineology Navigation InstrumentsSpineology, Inc.20221—
+8K220862E-GPS Navigated InstrumentsPrecision Spine, Inc.20227—
+8K220782IdentiTi™ Porous Ti Interbody System, IdentiTi™ NanoTec™ Interbody System, Transcend™…Alphatec Spine, Inc.202236—
+8K213654NuVasive Reline Cervical SystemNu Vasive, Incorporated20221—
+8K213720Vital Navigation SystemZimvie (Zimmer Biomet Spine, Inc.)20220—
+8K213460Invictus Spinal Fixation SystemAlphatec Spine, Inc.202117—
+8K211616ExcelsiusHubGlobus Medical, Inc.20219Class I
+8K211993Z-LINKPC SystemZavation Medical Products, LLC20210—
+8K211710Ascent POCT System, Centurion POCT System, Spinal Fixation System (SFS), Firebird Spinal…Orthofix, Inc.20212—
+8K210574NuVasive Pulse SystemNu Vasive, Incorporated202121
+8K211113Zavation Spinal SystemZavation Medical Products, LLC20214—
+8K211238SpineJack Expansion Kit, Vertaplex Radiopaque Bone Cement, Vertaplex HV Radiopaque Bone…Stryker Instruments20212—
+8K201569CUVIS-spineCurexo, Inc.20212—
+8K210874Reliance Spinal Screw SystemReliance Medical Systems, LLC20212—
+8K210539CoreLink Midline Fixation SystemCorelink, LLC20214—
+8K202184Practical Navigation Surgical Guidance System (PNSGS)Practical Navigation, LLC20215—
+8K200922Altus Spine HA Pedicle Screw SystemAltus Partners, LLC20213—
+8K203056Invictus™ Spinal Fixation SystemAlphatec Spine, Inc.202061—
+8K202327Invictus™ OsseoScrew® SystemAlphatec Spine, Inc.20200—
+8K200596G21 Cement, VADER® Pedicle SystemIcotec AG2020271
+8K200981Mega Plus MIS Spine SystemBk Meditech, Co., Ltd.20200—
+8K201240Mariner Cap SystemSeaSpine Orthopedics Corporation20200—
+8K200047ExcelsiusGPS Cranial 1.0 ModuleGlobus Medical, Inc.202053
+8K193423VADER®one Pedicle System MIS and LightMore® Pedicle System 6.0Icotec AG202061
+8K200896Solstice CCILife Spine, Inc.20200—
+8K192646SYMPHONY™ OCT SystemMedos International SARL20202—
+8K191655MEGAFIX® Pedicle Screw Spinal SystemSeohancare Co., Ltd.20200—
+8K190636NuVasive® Reline® 4.5-5.0 SystemNu Vasive, Incorporated201913—
+8K191553NuVaisve® Reline® Cervical SystemNu Vasive, Incorporated20192—
+8K191217Jazz PFImplanet, S.A.20190—
+8K191100ExcelsiusGPS Spine 1.1 Interbody ModuleGlobus Medical, Inc.201942—
+8K191045Salvo™ Spine SystemSpine Wave, Inc.20195—
+8K190360LineSider™ Spinal SystemIntegrity Implants, Inc.201913—
+8K190545VADER® one Pedicle System MIS and LightMore® Pedicle System 6.0Icotec AG2019291
+8K172105The Plateau-LO Spacer SystemLife Spine, Inc.20181—
+8K173130Reform® Midline Cortical Screw SystemPrecision Spine, Inc.201721—
+8K172469TiLock Modular Spinal SystemGenesys Spine20170—
+8K171570Additional VIPER PRIME™ screws with fenestrationsMedos International SARL201720—
+8K171881JAZZ Passer BandImplanet, S.A.20170—
+8K171456Thunderbolt™ Minimally Invasive and Lancer™ Open Pedicle Screw SystemsChoicespine20170—
+8K170730JAZZ System, including JAZZ BandImplanet, S.A.20175—
+8K170647Connector SystemOrthofix, Inc.201718—
+8K171082Firebird Spinal Fixation System, Phoenix MIS Spinal Fixation System, JANUS Midline…Orthofix, Inc.2017611
+8K160020Captiva Spine and CapLOX II/TowerLOX Pedicle Screw SystemCaptiva Spine20160—
+8K153463CD HORIZON Spinal System, IPC POWEREASE SystemMedtronic Sofamor Danek USA, Inc.201587—
+8K150552ELLIPSE and PROTEX CT OCCIPITO-CERVICO-THORACIC SPINAL SYSTEMSGlobus Medical, Inc.2015961
+9K262193RIVA® Posterior Fixation System with NanoACTIV Surface Technology; RIVA® Anchor…Xenix Medical20260—
+9K253216IntraOp Alignment System; CONTOUR3D Bending SystemAlphatec Spine, Inc.20260—
+9K260369Dynamis Robotic Surgical SystemLEM Surgical AG20260—
+9K261665CORUS™ Navigation System-GNProvidence Medical Technology, Inc.20260—
+9K252205Curiteva Porous PEEK Cervical Interbody System; Curiteva Porous PEEK Lumbar Interbody…Curiteva, Inc.20260—
+9K251943Spineology Navigation InstrumentsSpineology, Inc.20250—
+9K250599ExcelsiusGPS™ InstrumentsGlobus Medical, Inc.20250—
+9K252088Firebird SI Navigation SystemOrthofix US, LLC20251—
+9K252737DeGen Medical Latitude-C AM Cervical Interbody Fusion SystemDegen Medical20250—
+9K251060CORUS™ Navigation System-GXProvidence Medical Technology, Inc.20250—
+9K242900VADER® Pedicle System and VADER®one Pedicle SystemIcotec AG20250—
+9K243908Tiger 2 SystemZavation Medical Products, LLC20251—
+9K242260aprevo® Cervical ACDF; aprevo® Cervical ACDF-X; aprevo® Cervical ACDF-X NO CAMCarlsmed, Inc.20243—
+9K241077DeGen Medical Patient Specific Implant (PSI) SystemDegen Medical20242—
+9K242364IdentiTi™ II Interbody SystemAlphatec Spine, Inc.20244—
+9K242042TriALTIS™ Spine SystemMedos International SARL20241—
+9K241892Cortera™ Spinal Fixation SystemXtant Medical Holdings, Inc.20242—
+9K241863Erisma® Lp Spinal Fixation System; Erisma® LP MISClariance20240—
+9K233256Robotic Integration InstrumentsDePuy Synthes20240—
+9K233228Spine Navigation and Robotic-Assistance DeviceEcential Robotics202421
+9K240126ProAM ALIF SystemPro Surgical, Inc.20242—
+9K232432E3D™-A Interbody SystemEvolution Spine20248—
+9K233332Statera-C™ Spinal SystemK&J Consulting Corp.20230—
+9K233366SYMPHONY OCT SystemMedos International SARL20230—
+9K231811Zavation Connector SystemZavation Medical Products, LLC20230—
+9K230989Rod Registration FrameNu Vasive, Incorporated20230—
+9K222097OLYMPIC Deformity Band SystemAstura Medical20233—
+9K223513UniVy™ OsteoVy™-Ti Cervical IBF SystemVy Spine, LLC20231—
+9K222789VADER® Pedicle System, G21 CementIcotec AG202352
+9K223294SpineJack® Expansion KitStryker Instruments20221—
+9K222973IdentiTi and Transcend Interbody Systems: IndentiTi Cervical Porous Ti Interbody System…Alphatec Spine, Inc.202213—
+9K223070Remi Robotic Navigation SystemFusion Robotics, LLC20224—
+9K222270HEDRON Cervical Spacers, HEDRON Lumbar Spacers, SABLE Expandable Spacer, ExcelsiusGPS…Globus Medical, Inc.202223—