510(k) Report

Devices descending from K980485

643 later devices reach Isola Spinal System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+5K254148VERTICALE GPS InstrumentsSilony Medical GmbH20260—
+5K252597Valence Robotic Navigation System; Valence Robotic Navigation Instruments (For Use with…Alphatec Spine, Inc.20261—
+5K250520OsteoCentric Navigated Instruments SystemOsteocentric Technologies, Inc.20250—
+5K252322SIros-X SystemGenesys Spine20250—
+5K242827A8 INTEGR8™ Porous Pedicle ScrewsAllumin8, Inc.20251—
+5K251780iGPS Navigation InstrumentsSI-BONE, Inc.20250—
+5K251575IdentiTi™ II ALIF Standalone Interbody System; Transcend™ ALIF Standalone Interbody SystemAlphatec Spine20250—
+5K251073Innovasis Navigation Instruments (Vector G-E Navigation Instruments and the Excella G-E…Innovasis, Inc.202501
+5K241525ExcelsiusXR™Globus Medical, Inc.20250—
+5K243419Altus Spine Navigation SystemAltus Partners, LLC20250—
+5K243326Dynamis Robotic Surgical SystemLEM Surgical AG20251—
+5K243514Salvo® Robotic Navigation InstrumentsSpine Wave, Inc.20250—
+5K243814NuVasive Pulse SystemGlobus Medical, Inc.20250—
+5K243671ExcelsiusGPS® InstrumentsGlobus Medical, Inc.20240—
+5K242297Reform Pedicle Screw SystemPrecision Spine, Inc.20240—
+5K242764MediRod Pedicle Screw SystemCmf Medicon Surgical, Inc.20240—
+5K240160EGPS Navigated InstrumentsAstura Medical20240—
+5K242069Eminent Spine Scoliosis Deformity Pedicle Screw SystemEminent Spine20240—
+5K241892Cortera™ Spinal Fixation SystemXtant Medical Holdings, Inc.20242—
+5K241863Erisma® Lp Spinal Fixation System; Erisma® LP MISClariance20240—
+5K240721ExcelsiusFlex™Globus Medical, Inc.20240—
+5K240951Invictus Robotic Navigation InstrumentsAlphatec Spine20242—
+5K240568DuraPro™ Oscillating SystemGlobus Medical, Inc.20240—
+5K240846CarboClear® Hybrid Pedicle Screw System; CarboClear® Hybrid Navigated Instruments…CarboFix Orthopedics, Ltd.20242—
+5K233951CD Horizon ModuLeX Spinal System (Shanks, Head Assemblies, and Set Screw)Medtronic Sofamor Danek USA, Inc.20245—
+5K233989CarboClear® Posterior Cervical Screw SystemCarboFix Orthopedics, Ltd.20242—
+5K231850QUARTEX® Occipito-Cervico-Thoracic Spinal System ExcelsiusGPS® InstrumentsGlobus Medical, Inc.20242—
+5K233638VERZA™ High Speed DrillsGlobus Medical, Inc.20241—
+5K233508iFuse Bedrock Granite® Implant SystemSI-BONE, Inc.20245—
+5K233332Statera-C™ Spinal SystemK&J Consulting Corp.20230—
+5K231069PERLA® TL Posterior Thoraco-lumbar Fixation SystemSpineart SA20231—
+5K231809Momentum® Posterior Spinal Fixation System with G21 V-STEADY Bone Cement; Momentum® MIS…Ulrich Medical USA20231—
+5K232044Invictus Robotic Navigation InstrumentsAlphatec Spine, Inc.20233—
+5K223301ASTRA & AVANT Navigation Instruments System and ASTRA-OCT Navigation Instruments SystemSpinecraft, LLC20230—
+5K231799INERTIA® CONNEXX™ Modular Pedicle Screw SystemNexxt Spine, LLC20230—
+5K231280CarboClear® X Pedicle Screw System; CarboClear® X Navigated Instruments; CarboClear® X…CarboFix Orthopedics, Ltd.20234—
+5K223558CUVIS-spineCurexo, Inc.20230—
+5K222684XIA® 4.5 Spinal System, XIA® 4.5 Cortical Trajectory, XIA® 3 Spinal System, Serrato®…Stryker Spine20234—
+5K223096Dark Star Deformity Pedicle Screw SystemRepublic Spine, LLC20231—
+5K230880CoreLink Navigation InstrumentsCorelink, LLC20230—
+5K230766Altus Spine Monaco Pedicle Screw SystemAltus Spine20231—
+5K223350Remi Robotic Navigation SystemFusion Robotics, LLC20230—
+5K230063G Surgical Marksman Spinal Deformity SystemG Surgical, LLC20230—
+5K221926Invictus® Bone Cement, Invictus Spinal Fixation SystemAlphatec Spine, Inc.202214—
+5K211027Altus Spine Pedicle Screw SystemAltus Partners, LLC20222—
+5K221905INERTIA CONNEXX Modular Pedicle Screw SystemNexxt Spine, LLC20221—
+5K220862E-GPS Navigated InstrumentsPrecision Spine, Inc.20227—
+5K201788EDEN Spinal Fixation SystemJmt Co., Ltd.20221—
+5K220782IdentiTi™ Porous Ti Interbody System, IdentiTi™ NanoTec™ Interbody System, Transcend™…Alphatec Spine, Inc.202236—
+5K221244CD Horizon™ Spinal SystemMedtronic202220—
+5K213491Universal Pilot Guidance Instrument SystemCtl Medical Corporation20220—
+5K213935PISCES-SA Standalone ALIF Interbody SystemOsseus Fusion Systems202212—
+5K220038Camber Spine Navigation SystemCamber Spine Technologies20220—
+5K220025ARx® Spinal SystemLife Spine, Inc.20220—
+5K213470PERLA® TL Posterior Osteosynthesis SystemSpineart20222—
+5K213460Invictus Spinal Fixation SystemAlphatec Spine, Inc.202117—
+5K211616ExcelsiusHubGlobus Medical, Inc.20219Class I
+5K203607MOSS VRS Spinal SystemBiedermann Motech GmbH & Co. KG20210—
+5K201569CUVIS-spineCurexo, Inc.20212—
+5K202184Practical Navigation Surgical Guidance System (PNSGS)Practical Navigation, LLC20215—
+5K200922Altus Spine HA Pedicle Screw SystemAltus Partners, LLC20213—
+5K203506PERLA® TL posterior osteosynthesis systemSpineart202132
+5K203452Nano FortiFix® SystemNanovis, LLC20200—
+5K203222PERLA TL Posterior Osteosynthesis SystemSpineart20204—
+5K201427Trivergent Spinal Fixation SystemBenvenue Medical, Inc.20202—
+5K200596G21 Cement, VADER® Pedicle SystemIcotec AG2020271
+5K201926CarboClear® Pedicle Screw System, CarboClear® II Pedicle Screw SystemCarboFix Orthopedics, Ltd.202010—
+5K201251CarboClear Navigated InstrumentsCarboFix Orthopedics, Ltd.20209—
+5K200047ExcelsiusGPS Cranial 1.0 ModuleGlobus Medical, Inc.202053
+5K200322Altus Spine Pedicle Screw SystemAltus Partners, LLC20204—
+5K193423VADER®one Pedicle System MIS and LightMore® Pedicle System 6.0Icotec AG202061
+5K200245EXPEDIUM® Spine System; EXPEDIUM VERSE® Spine SystemMedos International Sàrl202012—
+5K193270CapLOX II®/TowerLOX® MIS Pedicle Screw SystemCaptiva Spine, Inc.20200—
+5K192800Streamline TL Spinal Fixation SystemPioneer Surgical Technology, Inc. (Dba Rti Surgical, Inc.)20203—
+5K192396Streamline MIS Spinal Fixation SystemPioneer Surgical Technology, Inc.20190—
+5K191854Premia Spine XL InstrumentsPremia Spine, Ltd.20190—
+5K190526High V+ Bone Cement, CarboClear® Fenestrated Pedicle ScrewsCarboFix Orthopedics, Ltd.201928—
+5K191575ARx Spinal SystemLife Spine, Inc.201910—
+5K191100ExcelsiusGPS Spine 1.1 Interbody ModuleGlobus Medical, Inc.201942—
+5K191045Salvo™ Spine SystemSpine Wave, Inc.20195—
+5K190545VADER® one Pedicle System MIS and LightMore® Pedicle System 6.0Icotec AG2019291
+5K190762The JASPER Spinal Fixation System IIGbs Commonwealth Co., Ltd.20191—
+5K183119SI-LOK® Sacroiliac Joint Fixation System, Navigation Instruments, ExcelsiusGPS®…Globus Medical, Inc.20192—
+5K182000AQrate Robotic Assistance SystemGlobus Medical, Inc.20191—
+5K182721Choice Spine Navigation SystemChoicespine, LP20192—
+5K183080Mega Plus Spine SystemBk Meditech, Co., Ltd.20182—
+5K182508Saxxony™ Posterior Cervical Thoracic SystemNexxt Spine, LLC20184—
+5K180980ORTHROS™ Posterior Stabilization System; ORTHROS™ MIS Posterior Stabilization SystemCamber Spine Technologies, LLC20181—
+5K182059Prase MIS Spinal SystemGbs Commonwealth Co., Ltd.20182—
+5K181821MOSS VRS Spinal SystemBiedermann Motech GmbH & Co. KG20181—
+5K181495Republic Spine Dark Star Spinal SystemRepublic Spine, LLC20183—
+5K181350ASTRA-OCT Spine SystemSpinecraft, LLC20180—
+5K181188EVEREST Spinal SystemK2m, Inc.20186—
+5K180475CapLOX II® / TowerLOX® MIS Pedicle Screw SystemCaptiva Spine, Inc.20180—
+5K172115Navigated Instrument SystemOrthofix, Inc.20184—
+5K173130Reform® Midline Cortical Screw SystemPrecision Spine, Inc.201721—
+5K172275Vitality® Spinal Fixation System, Vitality®+ Power Instrument SystemZimmer Biomet Spine, Inc.20170—
+5K171321K2M Navigation InstrumentsK2m201711
+5K171456Thunderbolt™ Minimally Invasive and Lancer™ Open Pedicle Screw SystemsChoicespine20170—
+5K171813OpenLoc-L Spinal Fixation System, LnK Spinal Fixation SystemL&K BIOMED Co., Ltd.201730—