510(k) Report

Devices descending from K980485

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

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+4K203153CREO Stabilization System, Navigation Instruments, ExcelsiusGPSGlobus Medical, Inc.20211—
+4K203125Invictus™ OCT Spinal Fixation SystemAlphatec Spine, Inc.20200—
+4K200789LnK MIS Spinal System, PathLoc-L MIS Spinal System, AccelFix-MIS Spinal SystemL&K BIOMED Co., Ltd.20200—
+4K203317CarboClear X Pedicle Screw SystemCarboFix Orthopedics, Ltd.20209—
+4K203056Invictus™ Spinal Fixation SystemAlphatec Spine, Inc.202061—
+4K200790LnK Spinal Fixation System, OpenLoc-L Spinal Fixation SystemL&K BIOMED Co., Ltd.20205—
+4K200937ACURA Stabilization SystemIndius Medical Technologies Pvt., Ltd.20200—
+4K202327Invictus™ OsseoScrew® SystemAlphatec Spine, Inc.20200—
+4K200981Mega Plus MIS Spine SystemBk Meditech, Co., Ltd.20200—
+4K200936Invictus™ CT Spinal Fixation SystemAlphatec Spine, Inc.20203—
+4K200303Reform Pedicle Screw SystemPrecision Spine202010—
+4K200519CarboClear® II Pedicle Screw SystemCarboFix Orthopedics, Ltd.202011—
+4K193211Nano FortiFix® SystemNanovis Spine, LLC20201—
+4K200267LOSPA® IS™ Spinal Fixation SystemCorentec Co., Ltd.20201—
+4K193396PERLA® TL posterior osteosynthesis systemSpineart202072
+4K190981NEX-D2 Posterior Fixation SystemNext Orthosurgical20200—
+4K193219G Surgical Marksman SystemG Surgical, LLC20191—
+4K192121Black Diamond Pedicle Screw SystemOsseus Fusion Systems201913—
+4K191932Momentum™ Posterior Spinal Fixation SystemUlrich Medical USA20192—
+4K191835CREO Stabilization System, Navigation Instruments, ExcelsiusGPS InstrumentsGlobus Medical, Inc.20192—
+4K182974NuVasive Reline SystemNu Vasive, Incorporated201911—
+4K182478Whistler Modular Pedicle Screw SystemEvolution Spine, LLC20196—
+4K182954Salvo™ Spine SystemSpine Wave, Inc.20186—
+4K181603EVEREST Spinal System, RANGE (MESA and DENALI) Spinal System, CASPIAN OCT (MESA Mini and…K2m, Inc.20185—
+4K182377CarboClear® Pedicle Screw SystemCarboFix Orthopedics, Ltd.201839—
+4K181978Zenius™, Iliad™ and Kora™ Spinal Fixation SystemsMedyssey USA, Inc.20180—
+4K181339Altus Spine Pedicle Screw SystemAltus Partners, LLC20186—
+4K173645JASPER Spinal Fixation SystemGbs Commonwealth Co., Ltd.20183—
+4K181139OLYMPIC Posterior Spinal Fixation SystemAstura Medical, LLC20188—
+4K181281Altus Spine Pedicle Screw SystemAltus Partners, LLC20181—
+4K180433Ennovate®Aesculap Implant Systems, LLC201811
+4K180458FOCUS Pedicle Screw SystemNvision Biomedical Technologies, LLC20181—
+4K180324Patriot Spinal Fixation SystemValorus Spine20180—
+4K173180Mega Plus Spine SystemBk Meditech, Co., Ltd.20183—
+4K173185SEURAT™ Universal Pedicle Screw SystemCtl Medical Corporation20180—
+4K173814DeGen Medical E3 MIS Pedicle Screw SystemDegen Medical20180—
+4K172469TiLock Modular Spinal SystemGenesys Spine20170—
+4K172101ROMEO® 2 Posterior Osteosynthesis SystemSpineart20179—
+4K172107Threshold™ V2 Pedicular Fixation System, Threshold™ Pedicular Fixation System, Fortress™…Spineology, Inc.20170—
+4K171651Excelsius GPSGlobus Medical, Inc.2017691
+4K171838TiLock2 Spinal SystemGenesys Spine20174—
+4K171907Vitality® Spinal Fixation SystemZimmer Biomet Spine, Inc.2017162
+4K171438Palisade™ Pedicular Fixation SystemSpineology, Inc.20171—
+4K162786PASS LP Spinal SystemMedicrea International SA20176—
+4K162576FORTEZZA Spinal Stabilization SystemOsso Surgical20160—
+4K161914Genesys Spine TiLock Cortical Spinal SystemGenesys Spine20161—
+4K161499VertiForm Posterior Fixation SystemNext Orthosurgical20161—
+4K161369EVEREST Spinal SystemK2m, Incorporated20169—
+4K153453Inertia Pedicle Screw and Deformity Correxxion SystemNexxt Spine, LLC201617—
+4K160208NILE Alternative Fixation Spinal SystemK2m, Inc.20165—
+4K153442CD HORIZON Spinal System, Medtronic Navigated Manual Reusable Instruments for Use with…Medtronic Sofamor Danek USA, Inc.201684—
+4K153428Firebird Spinal Fixation System, Phoenix MIS Spinal Fixation SystemOrthofix, Inc.2016731
+4K151770Libra Pedicle Screw SystemSpinal Balance, Inc.20151—
+4K153031RANGE/DENALI/MESA Spinal SystemK2m, Incorporated20152—
+4K152039Genesys Spine TiLock2 Spinal SystemGenesys Spine20157—
+4K151727Everest Spinal SystemK2m, Inc.201511—
+4K150856Reform Pedicle Screw SystemPrecision Spine, Inc.201526—
+4K151488Firebird Spinal Fixation System/Phoenix MIS Spinal Fixation SystemOrthofix, Inc.2015781
+4K143110GALAXY MIS Screw SystemBm Korea20152—
+4K150552ELLIPSE and PROTEX CT OCCIPITO-CERVICO-THORACIC SPINAL SYSTEMSGlobus Medical, Inc.2015961
+4K150283Republic Spine Dark Star Spinal SystemRepublic Spine, LLC20154—
+4K143363VENUS Spinal Fixation SystemL&K BIOMED Co., Ltd.201533—
+4K150647Polyscrew Pedicle Screw SystemNew Era Orthopedics, LLC201501
+4K150325Range/Denali/Mesa Spinal SystemK2m, Inc.201512—
+4K141222Nautilus Spinal System and Solstice Oct SystemLife Spine, Inc.201513—
+4K143633CREO Stabilization SystemGlobus Medical, Inc.2015158—
+4K141253New Era Orthopaedics Polyscrew Pedicle Screw SystemNew Era Orthopaedics, LLC201511
+4K143334Range/Denali/Mesa Spinal SystemK2m, Inc.201516—
+4K141186Firebird Spinal Fixation SystemOrthofix, Inc.20153—
+4K142185Expedium Verse Spine SystemDepuy Spine, Inc.201420—
+4K132049Thunderbolt and Lancer Pedicle Screw SystemsChoicespine201482—
+4K133402K2M Modular HooksK2m, Inc.20140—
+4K140529Everest Spinal SystemK2m, LLC201431—
+4K140123Polaris Spinal System -Translation ScrewEbi, LLC2014221
+4K140219Picasso II Mis Spinal SystemAccel Spine20141—
+4K140696Streamline TL Spinal Fixation SystemPioneer Surgical Technology, Inc.20145—
+4K133366Orthros Posterior Stabilization SystemCamber Spine20142—
+4K132361Everest Spinal SystemK2m, Inc.201334—
+4K131615Polaris Spinal SystemBiomet Spine (Aka Ebi, LLC)201370—
+4K131538Caplox II Pedicle Screw System/Towerlox Pedicle Screw SystemCaptiva Spine20136—
+4K131343Reform Pedicle Screw SystemSpinal USA201331—
+4K130279Reform Pedicle Screw SystemSpinal USA201331—
+4K131030Range Spinal SystemK2m, Inc.201334—
+4K123487Gso GS1 Cannulated Screw SystemGold Standard Orthopaedics, LLC20130—
+4K122814Galleon Pedicle Screw SystemEverest Spine, LLC20120—
+4K120469Erisma-LPClariance20126—
+4K120838Synthes Matrix SystemSynthes Spine201216—
+4K121130Polaris Spinal System-Ballista Spinal RodsBiomet Spine20121—
+4K120899Range Spinal System, Unit RodK2m, Inc.201235—
+4K120928Synthes Matrix SystemSynthes Spine20120—
+4K120656Everest Spinal SystemK2m, Inc.201243—
+4K113058Tiger Spine SystemCorelink, LLC201281—
+4K120140Focus Spinal SystemL&K BIOMED Co., Ltd.201225—
+4K103671Genesys Spine Tilock SystemGenesys Spine20118—
+4K101993Viper System, Expedium SystemDepuy Spine, Inc.20101628
+4K073430Valeo Pedicle Screw Spinal SystemAmedica Corp.200824—
+5K262067iFuse Granite Onyx™ Implant SystemSI-BONE, Inc.20260—
+5K261130AccelFix Spinal Fixation SystemL&K BIOMED Co., Ltd.20260—
+5K253966PERLA® TL Posterior Thoraco-lumbar Fixation SystemSpineart SA20260—
+5K253940M.U.S.T. Pedicle Screw System - ExtensionMedacta International S.A.20260—