510(k) Report

Devices descending from K980485

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

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+3K141873Range/Mesa/Denali Spinal SystemK2m, Inc.201430—
+3K141291Vertiform Posterior Fixation SystemNext Orthosurgical20142—
+3K140765Range/Mesa/Denali Spinal SystemK2m, Inc.201415—
+3K133575Spinevision Lumis Cannulated Pedicle Screw Fixation System, Spinevision U.L.I.S. Pedicle…Spinevision S.A.20143—
+3K141147Range Spinal SystemK2m, Inc.20141—
+3K133944Range, Spinal System, Everest Spinal SystemK2m, Inc.201433—
+3K133350Revere Stabilization SystemGlobus Medical, Inc.201493—
+3K133369Tiger Spine SystemCorelink, LLC201429—
+3K132403Annextm Adjacent Level SystemSpine Wave, Inc.20142—
+3K132603Apex Spine SystemSpinecraft, LLC201325—
+3K132757Everest Spinal SystemK2m, Inc.201341—
+3K132644Lospa IS Pedicle Screw (Monoaxial & Polyaxial), Lospa IS Rod- Straight (Standard), Lospa…Corentec Co., Ltd.20130—
+3K131784Range Spinal SystemK2m, Inc.201334—
+3K131810Osseus Black Diamond Pedicle Screw SystemOsseus Fusion Systems, LLC201314—
+3K130932Firebird Spinal Fixation SystemOrthofix, Inc.2013811
+3K124058Creo Stabilization SystemGlobus Medical, Inc.2013172—
+3K122877Range Spinal System, Small StatureK2m, Inc.201334—
+3K130330Range Spinal SystemK2m, Inc.201336—
+3K130291S4 Spinal SystemAesculap Implant System, Inc.201344—
+3K123783Ellipse Occipito-Cerico-Thoracic Spinal System and Capitol ImplantsGlobus Medical, Inc.201397—
+3K123549Polaris Spinal System - Ballista II Percutaneous Screw Placement SystemBiomet Spine (Aka Ebi, LLC)2013752
+3K123412Range Spinal System, Small Strature ComponentsK2m, Inc.201334—
+3K123521Reliance Spinal Screw SystemReliance Medical Systems, LLC20135—
+3K123352S4 Spinal SystemAesculap Implant Systems, Inc.201251—
+3K121728Tiger Spine SystemCorelink, LLC201250—
+3K121568Dali Spinal Fixation SystemAccel Spine20121—
+3K120714Picasso Mis Spinal Fixation SystemAccel Spine20122—
+3K121172Reform Pedicle Screw SystemSpinal USA201233—
+3K121016Range Spinal System (Mesa and Denali)K2m, Inc.201238—
+3K121020Viper SystemDepuy Spine, Inc.201294—
+3K120696Tiger Spine SystemCorelink, LLC201241—
+3K120270Venus Spinal Fixation SystemL&K BIOMED Co., Ltd.2012111—
+3K113396Depuy Pulse Thoracolumbar Screw SystemMedos International SARL20121—
+3K112643Focus Mis SystemL&K BIOMED Co., Ltd.201226—
+3K112920Range Spinal System (Mesa and Denali)K2m, Inc.201149—
+3K112551S4 Spinal SystemAesculap Implant System, Inc.201161—
+3K110906Apex Spine SystemSpinecraft, LLC2011103—
+3K110216Expedium System, Viper SystemDepuy Spine, Inc.20114—
+3K103133Veper System, Expedium SystemDepuy Spine, Inc.20110—
+3K102488Apex Spine System W/ Cocr RodsSpinecraft, LLC2010177—
+3K102204Choice Spine Starfire Pedicle Screw SystemChoicespine, LP201088—
+3K093926Firebird Spinal Fixation SystemBlackstone Medical, Inc.201088—
+3K100757Tilock Pedicle Screw SystemGenesys Spine201091
+3K092825Apex Spine System 5.50 MM Titanium Rod & Polyaxial Screw WasherSpinecraft, Inc.2010178—
+3K092626Modification to: Expedium Spine SystemDepuy Spine, Inc.20090—
+3K091110Spinal Edge Titan Pedicle Screw SystemSpinal Edge, LLC20091—
+3K090799Modification to Expedium Spine SystemDepuy Spine, Inc.20094—
+3K081898Expedium Spine SystemDepuy Spine, Inc.200859—
+3K082195Modifications to Expedium Spine SystemDepuy Spine, Inc.2008269—
+3K073562Modification to Viper Spine SystemDepuy Spine, Inc.2008213—
+3K080313Modification to Expedium Spine SystemDepuy Spine, Inc.2008397—
+3K070387Expedium Spine SystemDepuy Spine, Inc.2007248—
+3K062912Scient'x Spinal SystemScient'X200736—
+3K063741Expedium Spine SystemDepuy Spine, Inc.2007398—
+3K063156Modification to Expedium Spine SystemDepuy Spine, Inc.2006424—
+3K052131Expedium Spine System 5.5MM Commerically Pure Titanium Spinal RodsDepuy Spine, Inc.2005495—
+4K261284Invictus® Small Stature Spinal Fixation System; Invictus® 2.0 Spinal Fixation SystemAlphatec Spine, Inc.20260—
+4K260989Varion Thoracolumbar Fixation SystemKyocera Medical Technologies Inc. (KMTI)20260—
+4K253739SCRIPT™ Rods, CREO™ Stabilization System, REVERE® Stabilization System, REVERE® 4.5…Globus Medical, Inc.20260—
+4K253615Invictus Bands SystemAlphatec Spine, Inc.20260—
+4K253545Vulcan Spinal SystemK2m, Inc.20260—
+4K251719Momentum® Posterior Spinal Fixation SystemUlrich Medical USA, Inc.20250—
+4K251131Annex® 2 Adjacent Level SystemSpine Wave, Inc.20250—
+4K250582COLONNADE Posterior Screw Fixation SystemCG Bio Co., Ltd.20250—
+4K242900VADER® Pedicle System and VADER®one Pedicle SystemIcotec AG20250—
+4K243281LOCK-IN Spinal Fixation SystemLock-In USA Corp20240—
+4K243106CarboClear® Hybrid Pedicle Screw SystemCarboFix Orthopedics, Ltd.20240—
+4K230325GREENS BRAND Posterior, Non-cervical Pedicle Screw Spinal SystemGreens Surgicals Pvt., Ltd.20240—
+4K240180Orthopeasia Spinal Fixation SystemOrthopeasia Co., Ltd.20240—
+4K233793CarboClear® X Pedicle Screw SystemCarboFix Orthopedics, Ltd.20241—
+4K240872Erisma® Deformity Spinal System; Erisma® Lp Spinal Fixation SystemClariance20241—
+4K234048M.U.S.T. Pedicle Screw System - ExtensionMedacta International S.A.20241—
+4K233944CarboClear® X Pedicle Screw System; CarboClear® X Navigated InstrumentsCarboFix Orthopedics, Ltd.20243—
+4K232719ProMIS Extension Rod SystemPremia Spine, Ltd.20230—
+4K231694MASADA Modular Spinal Fixation SystemAstura Medical20232—
+4K231494CoreLink Robotic Navigation InstrumentsCorelink, LLC20230—
+4K232586Rexious Spinal Fixation System, Statera™ Spinal System, Statera-M™ Spinal SystemK&J Consulting Corp.20230—
+4K231744VyLink™ Spinal Screw SystemVy Spine, LLC20230—
+4K231658VEOS Spinal Fixation SystemSpineway20230—
+4K232341CarboClear® Pedicle Screw SystemCarboFix Orthopedics, Ltd.20234—
+4K232311LnK Spinal Fixation System /OpenLoc-L Spinal Fixation System, AccelFix Spinal Fixation…L&K BIOMED Co., Ltd.20231—
+4K231636LnK Spinal Fixation System /OpenLoc-L Spinal Fixation System, AccelFix Spinal Fixation…L&K BIOMED Co., Ltd.20232—
+4K222105RESPONSE 5.5/6.0 Cannulated Screw SystemOrthoPediatrics Corp.20230—
+4K230245LnK Spinal Fixation System/OpenLoc-L Spinal Fixation System; AccelFix Spinal Fixation…L&K BIOMED Co., Ltd.20233—
+4K223565LnK Spinal Fixation System /OpenLoc-L Spinal Fixation System, AccelFix Spinal Fixation…L&K BIOMED Co., Ltd.20224—
+4K223273ASTRA Spine SystemSpinecraft, LLC20228—
+4K213196MARVEL™ Growing RodsGlobus Medical, Inc.20220—
+4K221403Cortera Spinal Fixation SystemSurgalign Spine Technologies202232
+4K221776NextGen Pedicle Screw SystemCorelink, LLC20222—
+4K221332OsteoCentric Spine MIS Pedicle Fastener SystemOsteoCentric Technologies20221—
+4K214006Invictus® Spinal Fixation SystemAlphatec Spine, Inc.202216—
+4K213281PASS LP™ Spinal System, CD Horizon™ Spinal SystemMedicrea International SA20220—
+4K211935ORIO-Ti Intervertebral Body Fusion Cage SystemSpinecraft, LLC20210—
+4K212066Adena-Zina SystemShanghai Sanyou Medical Co, Ltd.20213—
+4K211323ASTRA Spine SystemSpinecraft, LLC202112—
+4K210874Reliance Spinal Screw SystemReliance Medical Systems, LLC20212—
+4K203742IdentiTi ALIF Standalone Interbody SystemAlphatec Spine, Inc.202159—
+4K210716CarboClear X Pedicle Screw System, CarboClear X Navigated InstrumentsCarboFix Orthopedics, Ltd.20218—
+4K210275Polaris Spinal SystemZimmer Biomet Spine, Inc.20210—
+4K201420Republic Spine Dark Star Spinal SystemRepublic Spine, LLC20212—