510(k) Report

Devices descending from K952236

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

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+5K182974NuVasive Reline SystemNu Vasive, Incorporated201911—
+5K180498NuVasive Reline Fenestrated Screws, High V+ Bone CementNu Vasive, Incorporated201841—
+5K182239OLYMPIC Posterior Spinal Fixation SystemAstura Medical, LLC20182—
+5K182240PASS LP Spinal SystemMedicrea International SA20182—
+5K181603EVEREST Spinal System, RANGE (MESA and DENALI) Spinal System, CASPIAN OCT (MESA Mini and…K2m, Inc.20185—
+5K181980OsseoScrew SystemAlphatec Spine, Inc.20181—
+5K181339Altus Spine Pedicle Screw SystemAltus Partners, LLC20186—
+5K173645JASPER Spinal Fixation SystemGbs Commonwealth Co., Ltd.20183—
+5K181068CREO® Stabilization System, REVERE® Stabilization SystemGlobus Medical, Inc.20182—
+5K181119Range (Denali and Mesa) Spinal SystemsK2m, Inc.20185—
+5K181281Altus Spine Pedicle Screw SystemAltus Partners, LLC20181—
+5K180376K2M Patient Specific RodsK2m, Inc.20182—
+5K180210CREO® Stabilization SystemGlobus Medical, Inc.201888—
+5K173185SEURAT™ Universal Pedicle Screw SystemCtl Medical Corporation20180—
+5K172469TiLock Modular Spinal SystemGenesys Spine20170—
+5K172808CosmoLock Pedicle Screw SystemKalitec Direct, LLC20172—
+5K171838TiLock2 Spinal SystemGenesys Spine20174—
+5K163096GPC BRAND Posterior, Non cervical Pedicle Screw Spinal SystemGpc Medical Limited20170—
+5K163471Kalitec Direct InSePtion™ MIS Fixation SystemKalitec Direct, LLC20176—
+5K162760Spine Wave Anterior Cervical Spine SystemSpine Wave, Inc.20171—
+5K170163Erisma® LP Spinal Fixation SystemClariance, Sas20172—
+5K162786PASS LP Spinal SystemMedicrea International SA20176—
+5K162576FORTEZZA Spinal Stabilization SystemOsso Surgical20160—
+5K161014NuVasive® Reline® SystemNu Vasive, Incorporated201648—
+5K161516G Surgical Marksman MIS SystemG Surgical, LLC20163—
+5K161914Genesys Spine TiLock Cortical Spinal SystemGenesys Spine20161—
+5K161369EVEREST Spinal SystemK2m, Incorporated20169—
+5K161363Arsenal Spinal Fixation SystemAlphatec Spine, Inc.201675—
+5K153453Inertia Pedicle Screw and Deformity Correxxion SystemNexxt Spine, LLC201617—
+5K160208NILE Alternative Fixation Spinal SystemK2m, Inc.20165—
+5K153428Firebird Spinal Fixation System, Phoenix MIS Spinal Fixation SystemOrthofix, Inc.2016731
+5K152968Arsenal Spinal Fixation SystemAlphatec Spine, Inc.201583—
+5K151770Libra Pedicle Screw SystemSpinal Balance, Inc.20151—
+5K153031RANGE/DENALI/MESA Spinal SystemK2m, Incorporated20152—
+5K152039Genesys Spine TiLock2 Spinal SystemGenesys Spine20157—
+5K151727Everest Spinal SystemK2m, Inc.201511—
+5K151488Firebird Spinal Fixation System/Phoenix MIS Spinal Fixation SystemOrthofix, Inc.2015781
+5K142835Iliad Pedicle Screw System and Zenius Pedicle Screw SystemMedyssey USA, Inc.20155—
+5K150283Republic Spine Dark Star Spinal SystemRepublic Spine, LLC20154—
+5K143363VENUS Spinal Fixation SystemL&K BIOMED Co., Ltd.201533—
+5K150325Range/Denali/Mesa Spinal SystemK2m, Inc.201512—
+5K143334Range/Denali/Mesa Spinal SystemK2m, Inc.201516—
+5K143149Arsenal Spinal Fixation SystemAlphatec Spine, Inc.201584—
+5K141186Firebird Spinal Fixation SystemOrthofix, Inc.20153—
+5K141695Acrosspine Pedicle Screw SystemArthro-Dif20140—
+5K142185Expedium Verse Spine SystemDepuy Spine, Inc.201420—
+5K141804Polaris Spinal System - HA CoatedBiomet Spine, LLC201421—
+5K132049Thunderbolt and Lancer Pedicle Screw SystemsChoicespine201482—
+5K133402K2M Modular HooksK2m, Inc.20140—
+5K140529Everest Spinal SystemK2m, LLC201431—
+5K133221Arsenal Spinal Fixation SystemAlphatec Spine, Inc.20141502
+5K133350Revere Stabilization SystemGlobus Medical, Inc.201493—
+5K132361Everest Spinal SystemK2m, Inc.201334—
+5K132644Lospa IS Pedicle Screw (Monoaxial & Polyaxial), Lospa IS Rod- Straight (Standard), Lospa…Corentec Co., Ltd.20130—
+5K124058Creo Stabilization SystemGlobus Medical, Inc.2013172—
+5K131030Range Spinal SystemK2m, Inc.201334—
+5K130291S4 Spinal SystemAesculap Implant System, Inc.201344—
+5K123783Ellipse Occipito-Cerico-Thoracic Spinal System and Capitol ImplantsGlobus Medical, Inc.201397—
+5K123549Polaris Spinal System - Ballista II Percutaneous Screw Placement SystemBiomet Spine (Aka Ebi, LLC)2013752
+5K123352S4 Spinal SystemAesculap Implant Systems, Inc.201251—
+5K120469Erisma-LPClariance20126—
+5K121016Range Spinal System (Mesa and Denali)K2m, Inc.201238—
+5K121130Polaris Spinal System-Ballista Spinal RodsBiomet Spine20121—
+5K120899Range Spinal System, Unit RodK2m, Inc.201235—
+5K120928Synthes Matrix SystemSynthes Spine20120—
+5K120353Synster Pedicle Screw System Synster Plus Pedicle Screw SystemBm Korea Co., Ltd.20123—
+5K120656Everest Spinal SystemK2m, Inc.201243—
+5K113058Tiger Spine SystemCorelink, LLC201281—
+5K111913Capsure (R) PS SystemSpine Wave, Inc.20111—
+5K103671Genesys Spine Tilock SystemGenesys Spine20118—
+5K111571Viper SystemsJohnson & Johnson2011203—
+5K101993Viper System, Expedium SystemDepuy Spine, Inc.20101628
+5K100605Mis SystemSpine Wave, Inc.201033—
+5K083353Capsure (R) PS SystemSpine Wave, Inc.200836—
+5K081898Expedium Spine SystemDepuy Spine, Inc.200859—
+5K082195Modifications to Expedium Spine SystemDepuy Spine, Inc.2008269—
+5K073430Valeo Pedicle Screw Spinal SystemAmedica Corp.200824—
+6K261284Invictus® Small Stature Spinal Fixation System; Invictus® 2.0 Spinal Fixation SystemAlphatec Spine, Inc.20260—
+6K261130AccelFix Spinal Fixation SystemL&K BIOMED Co., Ltd.20260—
+6K253940M.U.S.T. Pedicle Screw System - ExtensionMedacta International S.A.20260—
+6K253615Invictus Bands SystemAlphatec Spine, Inc.20260—
+6K253990KHEIRON® Spinal Fixation System, including patient specific K-RODS.M.A.I.O20262—
+6K253721KHEIRON® Spinal Fixation System, including patient specific K-RODS.M.A.I.O20252—
+6K253093Vital™ Spinal Fixation SystemHighridge Medical, LLC20250—
+6K250520OsteoCentric Navigated Instruments SystemOsteocentric Technologies, Inc.20250—
+6K252322SIros-X SystemGenesys Spine20250—
+6K252346OLYMPIC Posterior Spinal Fixation System; MASADA Modular Spinal Fixation SystemAstura Medical20250—
+6K242827A8 INTEGR8™ Porous Pedicle ScrewsAllumin8, Inc.20251—
+6K252437JAZZ Spinal SystemImplanet20250—
+6K251804KHEIRON® Spinal Fixation System, including patient specific K-RODS.M.A.I.O20254—
+6K251154RIVA Posterior Fixation System; RIVA Posterior Fixation System Navigation InstrumentsHt Medical D.B.A. Xenix Medical20251—
+6K243419Altus Spine Navigation SystemAltus Partners, LLC20250—
+6K250092HC Biologics Osteopoint Spinal Fixation SystemHC Biologics, LLC20250—
+6K243946EffortMed Spinal Fixation SystemEffortmed, LLC20251—
+6K243259MASADA Modular Spinal Fixation SystemAstura Medical20250—
+6K243281LOCK-IN Spinal Fixation SystemLock-In USA Corp20240—
+6K243106CarboClear® Hybrid Pedicle Screw SystemCarboFix Orthopedics, Ltd.20240—
+6K242069Eminent Spine Scoliosis Deformity Pedicle Screw SystemEminent Spine20240—
+6K241892Cortera™ Spinal Fixation SystemXtant Medical Holdings, Inc.20242—
+6K233793CarboClear® X Pedicle Screw SystemCarboFix Orthopedics, Ltd.20241—