510(k) Report

Devices descending from K052144

665 later devices reach TSRH Spinal System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+7K240872Erisma® Deformity Spinal System; Erisma® Lp Spinal Fixation SystemClariance20241—
+7K233638VERZA™ High Speed DrillsGlobus Medical, Inc.20241—
+7K233684TriALTIS™ Spine SystemMedos International SARL20234—
+7K233078Posterior Cervical Spine SystemDouble Medical Technology, Inc.20231—
+7K232719ProMIS Extension Rod SystemPremia Spine, Ltd.20230—
+7K233443Vital™ Navigation SystemZimvie Spine (Zimmer Biomet Spine, Inc.)20230—
+7K231494CoreLink Robotic Navigation InstrumentsCorelink, LLC20230—
+7K231809Momentum® Posterior Spinal Fixation System with G21 V-STEADY Bone Cement; Momentum® MIS…Ulrich Medical USA20231—
+7K231658VEOS Spinal Fixation SystemSpineway20230—
+7K232044Invictus Robotic Navigation InstrumentsAlphatec Spine, Inc.20233—
+7K232275Invictus® Spinal Fixation SystemAlphatec Spine, Inc.202311—
+7K223558CUVIS-spineCurexo, Inc.20230—
+7K231199Solar Lumbar Interbody Fusion SystemDegen Medical20235—
+7K230721ATEC Lateral Plate SystemAlphatec Spine, Inc.20230—
+7K230565HILINE™ Fixation SystemGlobus Medical, Inc.20230—
+7K223765ATEC Lateral Navigation InstrumentsAlphatec Spine, Inc.202302
+7K223350Remi Robotic Navigation SystemFusion Robotics, LLC20230—
+7K223413Pisces™-SA STANDALONE ALIF Interbody SystemOsseus Fusion Systems20233—
+7K222614Zavation Spinal SystemZavation Medical Products, LLC20223—
+7K221403Cortera Spinal Fixation SystemSurgalign Spine Technologies202232
+7K213876Spineology Navigation InstrumentsSpineology, Inc.20221—
+7K220862E-GPS Navigated InstrumentsPrecision Spine, Inc.20227—
+7K220782IdentiTi™ Porous Ti Interbody System, IdentiTi™ NanoTec™ Interbody System, Transcend™…Alphatec Spine, Inc.202236—
+7K213654NuVasive Reline Cervical SystemNu Vasive, Incorporated20221—
+7K213720Vital Navigation SystemZimvie (Zimmer Biomet Spine, Inc.)20220—
+7K213460Invictus Spinal Fixation SystemAlphatec Spine, Inc.202117—
+7K211616ExcelsiusHubGlobus Medical, Inc.20219Class I
+7K211993Z-LINKPC SystemZavation Medical Products, LLC20210—
+7K211710Ascent POCT System, Centurion POCT System, Spinal Fixation System (SFS), Firebird Spinal…Orthofix, Inc.20212—
+7K210574NuVasive Pulse SystemNu Vasive, Incorporated202121
+7K211113Zavation Spinal SystemZavation Medical Products, LLC20214—
+7K211238SpineJack Expansion Kit, Vertaplex Radiopaque Bone Cement, Vertaplex HV Radiopaque Bone…Stryker Instruments20212—
+7K201569CUVIS-spineCurexo, Inc.20212—
+7K210874Reliance Spinal Screw SystemReliance Medical Systems, LLC20212—
+7K210539CoreLink Midline Fixation SystemCorelink, LLC20214—
+7K202184Practical Navigation Surgical Guidance System (PNSGS)Practical Navigation, LLC20215—
+7K200922Altus Spine HA Pedicle Screw SystemAltus Partners, LLC20213—
+7K203056Invictus™ Spinal Fixation SystemAlphatec Spine, Inc.202061—
+7K202327Invictus™ OsseoScrew® SystemAlphatec Spine, Inc.20200—
+7K200596G21 Cement, VADER® Pedicle SystemIcotec AG2020271
+7K200981Mega Plus MIS Spine SystemBk Meditech, Co., Ltd.20200—
+7K201240Mariner Cap SystemSeaSpine Orthopedics Corporation20200—
+7K200047ExcelsiusGPS Cranial 1.0 ModuleGlobus Medical, Inc.202053
+7K193423VADER®one Pedicle System MIS and LightMore® Pedicle System 6.0Icotec AG202061
+7K200896Solstice CCILife Spine, Inc.20200—
+7K192646SYMPHONY™ OCT SystemMedos International SARL20202—
+7K191655MEGAFIX® Pedicle Screw Spinal SystemSeohancare Co., Ltd.20200—
+7K190636NuVasive® Reline® 4.5-5.0 SystemNu Vasive, Incorporated201913—
+7K191553NuVaisve® Reline® Cervical SystemNu Vasive, Incorporated20192—
+7K191217Jazz PFImplanet, S.A.20190—
+7K191100ExcelsiusGPS Spine 1.1 Interbody ModuleGlobus Medical, Inc.201942—
+7K191045Salvo™ Spine SystemSpine Wave, Inc.20195—
+7K190360LineSider™ Spinal SystemIntegrity Implants, Inc.201913—
+7K190545VADER® one Pedicle System MIS and LightMore® Pedicle System 6.0Icotec AG2019291
+7K172105The Plateau-LO Spacer SystemLife Spine, Inc.20181—
+7K173130Reform® Midline Cortical Screw SystemPrecision Spine, Inc.201721—
+7K172469TiLock Modular Spinal SystemGenesys Spine20170—
+7K171570Additional VIPER PRIME™ screws with fenestrationsMedos International SARL201720—
+7K171881JAZZ Passer BandImplanet, S.A.20170—
+7K171456Thunderbolt™ Minimally Invasive and Lancer™ Open Pedicle Screw SystemsChoicespine20170—
+7K170730JAZZ System, including JAZZ BandImplanet, S.A.20175—
+7K170647Connector SystemOrthofix, Inc.201718—
+7K171082Firebird Spinal Fixation System, Phoenix MIS Spinal Fixation System, JANUS Midline…Orthofix, Inc.2017611
+7K160020Captiva Spine and CapLOX II/TowerLOX Pedicle Screw SystemCaptiva Spine20160—
+7K153463CD HORIZON Spinal System, IPC POWEREASE SystemMedtronic Sofamor Danek USA, Inc.201587—
+7K150552ELLIPSE and PROTEX CT OCCIPITO-CERVICO-THORACIC SPINAL SYSTEMSGlobus Medical, Inc.2015961
+8K262193RIVA® Posterior Fixation System with NanoACTIV Surface Technology; RIVA® Anchor…Xenix Medical20260—
+8K253216IntraOp Alignment System; CONTOUR3D Bending SystemAlphatec Spine, Inc.20260—
+8K260369Dynamis Robotic Surgical SystemLEM Surgical AG20260—
+8K261665CORUS™ Navigation System-GNProvidence Medical Technology, Inc.20260—
+8K252205Curiteva Porous PEEK Cervical Interbody System; Curiteva Porous PEEK Lumbar Interbody…Curiteva, Inc.20260—
+8K251943Spineology Navigation InstrumentsSpineology, Inc.20250—
+8K250599ExcelsiusGPS™ InstrumentsGlobus Medical, Inc.20250—
+8K252088Firebird SI Navigation SystemOrthofix US, LLC20251—
+8K252737DeGen Medical Latitude-C AM Cervical Interbody Fusion SystemDegen Medical20250—
+8K251060CORUS™ Navigation System-GXProvidence Medical Technology, Inc.20250—
+8K242900VADER® Pedicle System and VADER®one Pedicle SystemIcotec AG20250—
+8K243908Tiger 2 SystemZavation Medical Products, LLC20251—
+8K242260aprevo® Cervical ACDF; aprevo® Cervical ACDF-X; aprevo® Cervical ACDF-X NO CAMCarlsmed, Inc.20243—
+8K241077DeGen Medical Patient Specific Implant (PSI) SystemDegen Medical20242—
+8K242364IdentiTi™ II Interbody SystemAlphatec Spine, Inc.20244—
+8K242042TriALTIS™ Spine SystemMedos International SARL20241—
+8K241892Cortera™ Spinal Fixation SystemXtant Medical Holdings, Inc.20242—
+8K241863Erisma® Lp Spinal Fixation System; Erisma® LP MISClariance20240—
+8K233256Robotic Integration InstrumentsDePuy Synthes20240—
+8K233228Spine Navigation and Robotic-Assistance DeviceEcential Robotics202421
+8K240126ProAM ALIF SystemPro Surgical, Inc.20242—
+8K232432E3D™-A Interbody SystemEvolution Spine20248—
+8K233332Statera-C™ Spinal SystemK&J Consulting Corp.20230—
+8K233366SYMPHONY OCT SystemMedos International SARL20230—
+8K231811Zavation Connector SystemZavation Medical Products, LLC20230—
+8K230989Rod Registration FrameNu Vasive, Incorporated20230—
+8K222097OLYMPIC Deformity Band SystemAstura Medical20233—
+8K223513UniVy™ OsteoVy™-Ti Cervical IBF SystemVy Spine, LLC20231—
+8K222789VADER® Pedicle System, G21 CementIcotec AG202352
+8K223294SpineJack® Expansion KitStryker Instruments20221—
+8K222973IdentiTi and Transcend Interbody Systems: IndentiTi Cervical Porous Ti Interbody System…Alphatec Spine, Inc.202213—
+8K223070Remi Robotic Navigation SystemFusion Robotics, LLC20224—
+8K222270HEDRON Cervical Spacers, HEDRON Lumbar Spacers, SABLE Expandable Spacer, ExcelsiusGPS…Globus Medical, Inc.202223—
+8K222698CUVIS-spineCurexo, Inc.20220—