510(k) Report

Devices descending from K022285

403 later devices reach Modification to Isola Spinal System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+4K200267LOSPA® IS™ Spinal Fixation SystemCorentec Co., Ltd.20201—
+4K190526High V+ Bone Cement, CarboClear® Fenestrated Pedicle ScrewsCarboFix Orthopedics, Ltd.201928—
+4K191575ARx Spinal SystemLife Spine, Inc.201910—
+4K190545VADER® one Pedicle System MIS and LightMore® Pedicle System 6.0Icotec AG2019291
+4K181603EVEREST Spinal System, RANGE (MESA and DENALI) Spinal System, CASPIAN OCT (MESA Mini and…K2m, Inc.20185—
+4K181068CREO® Stabilization System, REVERE® Stabilization SystemGlobus Medical, Inc.20182—
+4K181119Range (Denali and Mesa) Spinal SystemsK2m, Inc.20185—
+4K180376K2M Patient Specific RodsK2m, Inc.20182—
+4K173814DeGen Medical E3 MIS Pedicle Screw SystemDegen Medical20180—
+4K173508Everest Spinal SystemK2m20189—
+4K173130Reform® Midline Cortical Screw SystemPrecision Spine, Inc.201721—
+4K172275Vitality® Spinal Fixation System, Vitality®+ Power Instrument SystemZimmer Biomet Spine, Inc.20170—
+4K172107Threshold™ V2 Pedicular Fixation System, Threshold™ Pedicular Fixation System, Fortress™…Spineology, Inc.20170—
+4K171438Palisade™ Pedicular Fixation SystemSpineology, Inc.20171—
+4K162576FORTEZZA Spinal Stabilization SystemOsso Surgical20160—
+4K161369EVEREST Spinal SystemK2m, Incorporated20169—
+4K160208NILE Alternative Fixation Spinal SystemK2m, Inc.20165—
+4K153428Firebird Spinal Fixation System, Phoenix MIS Spinal Fixation SystemOrthofix, Inc.2016731
+4K153031RANGE/DENALI/MESA Spinal SystemK2m, Incorporated20152—
+4K151727Everest Spinal SystemK2m, Inc.201511—
+4K151488Firebird Spinal Fixation System/Phoenix MIS Spinal Fixation SystemOrthofix, Inc.2015781
+4K150325Range/Denali/Mesa Spinal SystemK2m, Inc.201512—
+4K143334Range/Denali/Mesa Spinal SystemK2m, Inc.201516—
+4K141186Firebird Spinal Fixation SystemOrthofix, Inc.20153—
+4K133402K2M Modular HooksK2m, Inc.20140—
+4K140529Everest Spinal SystemK2m, LLC201431—
+4K132361Everest Spinal SystemK2m, Inc.201334—
+4K121130Polaris Spinal System-Ballista Spinal RodsBiomet Spine20121—
+4K120928Synthes Matrix SystemSynthes Spine20120—
+4K110551Expedium Spine SystemJohnson & Johnson20111—
+4K101070Expedium Spine SystemMedos International SARL20102601
+5K262067iFuse Granite Onyx™ Implant SystemSI-BONE, Inc.20260—
+5K261284Invictus® Small Stature Spinal Fixation System; Invictus® 2.0 Spinal Fixation SystemAlphatec Spine, Inc.20260—
+5K260989Varion Thoracolumbar Fixation SystemKyocera Medical Technologies Inc. (KMTI)20260—
+5K253739SCRIPT™ Rods, CREO™ Stabilization System, REVERE® Stabilization System, REVERE® 4.5…Globus Medical, Inc.20260—
+5K253615Invictus Bands SystemAlphatec Spine, Inc.20260—
+5K254045CarboClear® Posterior Cervical Screw System; CarboClear® Hybrid Posterior Cervical Screw…CarboFix Orthopedics, Ltd.20260—
+5K252327CMORE® CT System; CMORE® CT System Navigated InstrumentsIcotec AG20251—
+5K251780iGPS Navigation InstrumentsSI-BONE, Inc.20250—
+5K250845Curiteva Porous PEEK Standalone ALIF SystemCuriteva, Inc.20251—
+5K243514Salvo® Robotic Navigation InstrumentsSpine Wave, Inc.20250—
+5K242900VADER® Pedicle System and VADER®one Pedicle SystemIcotec AG20250—
+5K240326Solar™ Lumbar Interbody Fusion SystemDegen Medical, Inc.20244—
+5K233256Robotic Integration InstrumentsDePuy Synthes20240—
+5K231494CoreLink Robotic Navigation InstrumentsCorelink, LLC20230—
+5K231809Momentum® Posterior Spinal Fixation System with G21 V-STEADY Bone Cement; Momentum® MIS…Ulrich Medical USA20231—
+5K232044Invictus Robotic Navigation InstrumentsAlphatec Spine, Inc.20233—
+5K230774PERLA® TL System; TEKTONA® HV US Bone CementSpineart20230—
+5K231199Solar Lumbar Interbody Fusion SystemDegen Medical20235—
+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—
+5K223413Pisces™-SA STANDALONE ALIF Interbody SystemOsseus Fusion Systems20233—
+5K222789VADER® Pedicle System, G21 CementIcotec AG202352
+5K221926Invictus® Bone Cement, Invictus Spinal Fixation SystemAlphatec Spine, Inc.202214—
+5K213196MARVEL™ Growing RodsGlobus Medical, Inc.20220—
+5K221776NextGen Pedicle Screw SystemCorelink, LLC20222—
+5K221905INERTIA CONNEXX Modular Pedicle Screw SystemNexxt Spine, LLC20221—
+5K202836GX Navigation Instrument SystemLife Spine, Inc.20211—
+5K200070ARx Spinal SystemLife Spine, Inc.20209—
+5K181188EVEREST Spinal SystemK2m, Inc.20186—
+5K172115Navigated Instrument SystemOrthofix, Inc.20184—
+5K171321K2M Navigation InstrumentsK2m201711
+5K171456Thunderbolt™ Minimally Invasive and Lancer™ Open Pedicle Screw SystemsChoicespine20170—
+5K170821ChoiceSpine™ Proliant® Posterior Pedicle Screw and Hook Fixation SystemChoicespine, LP20170—
+5K170647Connector SystemOrthofix, Inc.201718—
+5K171082Firebird Spinal Fixation System, Phoenix MIS Spinal Fixation System, JANUS Midline…Orthofix, Inc.2017611
+5K161842Overwatch Spine SystemAmendia, Inc.201661
+5K142360Everest Spinal SystemK2m, Inc.201522—
+5K131250Tiger Spine SystemCorelink, LLC201340—
+5K130877Expedium Spine SystemMedos International SARL20138—
+5K123451Polaris Spinal System - Ballista II RodsBiomet Spine (Aka Ebi, LLC)20120—
+5K122226Revere Stabilization SystemGlobus Medical, Inc.2012225—
+6K260571SIMPACT Sacroiliac Joint Fixation System GX Navigation InstrumentsLife Spine, Inc.20260—
+6K252205Curiteva Porous PEEK Cervical Interbody System; Curiteva Porous PEEK Lumbar Interbody…Curiteva, Inc.20260—
+6K252737DeGen Medical Latitude-C AM Cervical Interbody Fusion SystemDegen Medical20250—
+6K241077DeGen Medical Patient Specific Implant (PSI) SystemDegen Medical20242—
+6K240951Invictus Robotic Navigation InstrumentsAlphatec Spine20242—
+6K240126ProAM ALIF SystemPro Surgical, Inc.20242—
+6K240872Erisma® Deformity Spinal System; Erisma® Lp Spinal Fixation SystemClariance20241—
+6K232628VADER® Pedicle SystemIcotec AG20241—
+6K231443Mini-OSTEO Pedicle Fixation SystemOsteomed Indústria E Comércio DE Implantes Ltda20230—
+6K232275Invictus® Spinal Fixation SystemAlphatec Spine, Inc.202311—
+6K231811Zavation Connector SystemZavation Medical Products, LLC20230—
+6K231799INERTIA® CONNEXX™ Modular Pedicle Screw SystemNexxt Spine, LLC20230—
+6K230721ATEC Lateral Plate SystemAlphatec Spine, Inc.20230—
+6K230880CoreLink Navigation InstrumentsCorelink, LLC20230—
+6K213491Universal Pilot Guidance Instrument SystemCtl Medical Corporation20220—
+6K220341ARx Modular Spinal SystemLife Spine, Inc.20221—
+6K210549ARx Spinal SystemLife Spine, Inc.20211—
+6K203163ARx Illiac Spinal Screw SystemLife Spine, Inc.20205—
+6K201006K2M Navigation InstrumentsK2m, Inc.20200—
+6K191722Vital Navigation SystemZimmer Biomet Spine, Inc.20192—
+6K191576Mercury® Spinal System, Overwatch® Spinal SystemSpinal Elements, Inc.20195—
+6K182416NOVA Minimally Invasive SystemBaui Biotech Co., Ltd.20192—
+6K183639Mariner Outrigger Revision SystemSeaSpine Orthopedics Corporation20198—
+6K183430Modular Spinal Fixation SystemLife Spine, Inc.20192—
+6K180980ORTHROS™ Posterior Stabilization System; ORTHROS™ MIS Posterior Stabilization SystemCamber Spine Technologies, LLC20181—
+6K180179Firebird® Spinal Fixation Systems: Firebird System; Firebird Deformity System; Firebird®…Orthofix, Inc.201837—
+6K180210CREO® Stabilization SystemGlobus Medical, Inc.201888—
+6K172194Connector SystemOrthofix, Inc.2017162