510(k) Report

Devices descending from K952236

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

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+7K183119SI-LOK® Sacroiliac Joint Fixation System, Navigation Instruments, ExcelsiusGPS®…Globus Medical, Inc.20192—
+7K182000AQrate Robotic Assistance SystemGlobus Medical, Inc.20191—
+7K183168OpenLoc-L Spinal Fixation SystemL&K BIOMED Co., Ltd.201823—
+7K183080Mega Plus Spine SystemBk Meditech, Co., Ltd.20182—
+7K182598VersaLink™ Fixation SystemPremia Spine, Ltd.20180—
+7K182508Saxxony™ Posterior Cervical Thoracic SystemNexxt Spine, LLC20184—
+7K181846ASSURE Anterior Cervical Plate System, PROVIDENCE Anterior Cervical Plate System, VIP…Globus Medical, Inc.20184—
+7K180980ORTHROS™ Posterior Stabilization System; ORTHROS™ MIS Posterior Stabilization SystemCamber Spine Technologies, LLC20181—
+7K181821MOSS VRS Spinal SystemBiedermann Motech GmbH & Co. KG20181—
+7K180179Firebird® Spinal Fixation Systems: Firebird System; Firebird Deformity System; Firebird®…Orthofix, Inc.201837—
+7K181978Zenius™, Iliad™ and Kora™ Spinal Fixation SystemsMedyssey USA, Inc.20180—
+7K181350ASTRA-OCT Spine SystemSpinecraft, LLC20180—
+7K180433Ennovate®Aesculap Implant Systems, LLC201811
+7K171421VERTICALE® Posterior Spinal Fixation System/VERTICALE® SystemSilony Medical GmbH20186—
+7K173130Reform® Midline Cortical Screw SystemPrecision Spine, Inc.201721—
+7K171582NEO Pedicle Screw System™Neo Medical SA20170—
+7K172107Threshold™ V2 Pedicular Fixation System, Threshold™ Pedicular Fixation System, Fortress™…Spineology, Inc.20170—
+7K172194Connector SystemOrthofix, Inc.2017162
+7K171438Palisade™ Pedicular Fixation SystemSpineology, Inc.20171—
+7K170989Dymaxeon Spine SystemBack 2 Basics Direct, LLC20172—
+7K170061ProMIS™ Fixation SystemPremia Spine, Ltd.20170—
+7K162367Erisma® LP MISClariance, Sas20162—
+7K161591QUARTEX™ Occipito-Cervico-Thoracic Spinal System, Globus Navigation InstrumentsGlobus Medical, Inc.201678—
+7K161387Mont Blanc and Mont Blanc MIS Spinal SystemsSpineway SA20163—
+7K153442CD HORIZON Spinal System, Medtronic Navigated Manual Reusable Instruments for Use with…Medtronic Sofamor Danek USA, Inc.201684—
+7K153370Caspian OCT/MESA Mini/DENALI Mini Spinal SystemK2m, Incorporated201617—
+7K151974Polaris Spinal SystemBiomet Spine201516—
+7K150896Vitality Spinal Fixation SystemZimmer Spine, Inc.2015193
+7K152174Sniper Spine SystemSpine Wave, Inc.20158—
+7K151216Everest Spinal SystemK2m, Inc.201511—
+7K151196Nautilus Spinal SystemLife Spine, Inc.201512—
+7K150856Reform Pedicle Screw SystemPrecision Spine, Inc.201526—
+7K143377PedFuse Pedicle Screw SystemSpinefrontier, Inc.20150—
+7K143200MIS Z-Pedicle Screw SystemZ-Medical GmbH & Co. KG201514—
+7K143248Reform Pedicle Screw SystemPrecision Spine, Inc.201430—
+7K133153Spinefrontier Pedfuse Pedicle Screw SystemSpinefrontier, Inc.20141—
+7K131538Caplox II Pedicle Screw System/Towerlox Pedicle Screw SystemCaptiva Spine20136—
+7K131343Reform Pedicle Screw SystemSpinal USA201331—
+7K130279Reform Pedicle Screw SystemSpinal USA201331—
+7K123487Gso GS1 Cannulated Screw SystemGold Standard Orthopaedics, LLC20130—
+7K123373Nautilus Spinal SystemLife Spine201317—
+7K122332Towerlox Pedicle Screw SystemCaptiva Spine201214—
+7K111953Nautilus Spinal SystemLife Spine20123—
+7K120292Caplox II Pedicle Screw SystemCaptiva Spine, Inc.2012151
+7K090320Conquest Spinal SystemLife Spine20092—
+8K262712Duet™ Spinal Fixation SystemDuet Spine Holdings, LLC20260—
+8K253943Tiger 2 SystemZavation Medical Products, LLC20260—
+8K253216IntraOp Alignment System; CONTOUR3D Bending SystemAlphatec Spine, Inc.20260—
+8K260369Dynamis Robotic Surgical SystemLEM Surgical AG20260—
+8K261665CORUS™ Navigation System-GNProvidence Medical Technology, Inc.20260—
+8K253045“Socko” Vimax Spinal Fixation SystemSocko Medical Co., Ltd.20260—
+8K251251ChanPin Pedicle Screw Spinal SystemChanpin Medtak Co., Ltd.20260—
+8K260571SIMPACT Sacroiliac Joint Fixation System GX Navigation InstrumentsLife Spine, Inc.20260—
+8K253966PERLA® TL Posterior Thoraco-lumbar Fixation SystemSpineart SA20260—
+8K254045CarboClear® Posterior Cervical Screw System; CarboClear® Hybrid Posterior Cervical Screw…CarboFix Orthopedics, Ltd.20260—
+8K252205Curiteva Porous PEEK Cervical Interbody System; Curiteva Porous PEEK Lumbar Interbody…Curiteva, Inc.20260—
+8K252729Universal Spinal SystemDouble Medical Technology, Inc.20250—
+8K252327CMORE® CT System; CMORE® CT System Navigated InstrumentsIcotec AG20251—
+8K250599ExcelsiusGPS™ InstrumentsGlobus Medical, Inc.20250—
+8K252737DeGen Medical Latitude-C AM Cervical Interbody Fusion SystemDegen Medical20250—
+8K251060CORUS™ Navigation System-GXProvidence Medical Technology, Inc.20250—
+8K242674Freedom Posterior Cervical ScrewsSignature Orthopaedics Pty, Ltd.20250—
+8K242516EUROPA™ Posterior Cervical Fusion SystemMiRus, LLC20242—
+8K242260aprevo® Cervical ACDF; aprevo® Cervical ACDF-X; aprevo® Cervical ACDF-X NO CAMCarlsmed, Inc.20243—
+8K241077DeGen Medical Patient Specific Implant (PSI) SystemDegen Medical20242—
+8K242899NOVA Minimally Invasive SystemBaui Biotech Co., Ltd.20240—
+8K230325GREENS BRAND Posterior, Non-cervical Pedicle Screw Spinal SystemGreens Surgicals Pvt., Ltd.20240—
+8K242364IdentiTi™ II Interbody SystemAlphatec Spine, Inc.20244—
+8K233256Robotic Integration InstrumentsDePuy Synthes20240—
+8K233228Spine Navigation and Robotic-Assistance DeviceEcential Robotics202421
+8K240126ProAM ALIF SystemPro Surgical, Inc.20242—
+8K233951CD Horizon ModuLeX Spinal System (Shanks, Head Assemblies, and Set Screw)Medtronic Sofamor Danek USA, Inc.20245—
+8K232628VADER® Pedicle SystemIcotec AG20241—
+8K232432E3D™-A Interbody SystemEvolution Spine20248—
+8K233735ADIRA™ Lateral Plate SystemGlobus Medical, Inc.20240—
+8K233455ARx MIS Spinal Screw SystemLife Spine, Inc.20230—
+8K231923Liberty SI Lateral Implant SystemSpinal Simplicity, LLC20230—
+8K233443Vital™ Navigation SystemZimvie Spine (Zimmer Biomet Spine, Inc.)20230—
+8K231069PERLA® TL Posterior Thoraco-lumbar Fixation SystemSpineart SA20231—
+8K231479TriALTIS Spine SystemMedos International SARL20238—
+8K223301ASTRA & AVANT Navigation Instruments System and ASTRA-OCT Navigation Instruments SystemSpinecraft, LLC20230—
+8K223806VERTICALE® Triangular Fixation SystemSilony Medical GmbH20230—
+8K230762EDEN Spinal Fixation MIS SystemJmt Co., Ltd.20230—
+8K223513UniVy™ OsteoVy™-Ti Cervical IBF SystemVy Spine, LLC20231—
+8K222614Zavation Spinal SystemZavation Medical Products, LLC20223—
+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—
+8K222028IdentiTi™ Porous Ti Interbody System, IdentiTi™ NanoTec™ Interbody System, Transcend™…Alphatec Spine202228—
+8K221388NuVasive Reline Cervical SystemNu Vasive, Incorporated20220—
+8K222256BonOs® Inject Bone Cement; NEO Pedicle Screw System™Neo Medical SA20223—
+8K220024ChoiceSpine Navigation SystemChoice Spine, LLC20220—
+8K221244CD Horizon™ Spinal SystemMedtronic202220—
+8K220038Camber Spine Navigation SystemCamber Spine Technologies20220—
+8K212962TRELLIS™ SI Joint Fusion SystemOrthofundamentals, LLC20220—
+8K213470PERLA® TL Posterior Osteosynthesis SystemSpineart20222—
+8K213720Vital Navigation SystemZimvie (Zimmer Biomet Spine, Inc.)20220—
+8K211957QUARTEX Occipito-Cervico-Thoracic Spinal System, Globus Navigation InstrumentsGlobus Medical, Inc.20213—
+8K211710Ascent POCT System, Centurion POCT System, Spinal Fixation System (SFS), Firebird Spinal…Orthofix, Inc.20212—