510(k) Report

Devices descending from K993030

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

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+6K190751Connector SystemOrthofix, Inc.20193—
+6K190376PASS LP Spinal SystemMedicrea International SA201915
+6K182478Whistler Modular Pedicle Screw SystemEvolution Spine, LLC20196—
+6K182954Salvo™ Spine SystemSpine Wave, Inc.20186—
+6K182239OLYMPIC Posterior Spinal Fixation SystemAstura Medical, LLC20182—
+6K182240PASS LP Spinal SystemMedicrea International SA20182—
+6K182059Prase MIS Spinal SystemGbs Commonwealth Co., Ltd.20182—
+6K181139OLYMPIC Posterior Spinal Fixation SystemAstura Medical, LLC20188—
+6K181068CREO® Stabilization System, REVERE® Stabilization SystemGlobus Medical, Inc.20182—
+6K180433Ennovate®Aesculap Implant Systems, LLC201811
+6K173180Mega Plus Spine SystemBk Meditech, Co., Ltd.20183—
+6K172107Threshold™ V2 Pedicular Fixation System, Threshold™ Pedicular Fixation System, Fortress™…Spineology, Inc.20170—
+6K171651Excelsius GPSGlobus Medical, Inc.2017691
+6K171813OpenLoc-L Spinal Fixation System, LnK Spinal Fixation SystemL&K BIOMED Co., Ltd.201730—
+6K171438Palisade™ Pedicular Fixation SystemSpineology, Inc.20171—
+6K162750Libra Pedicle Screw SystemSpinal Balance, Inc.20160—
+6K162367Erisma® LP MISClariance, Sas20162—
+6K161499VertiForm Posterior Fixation SystemNext Orthosurgical20161—
+6K151977icotec Pedicle SystemIcotec AG201630—
+6K151422Reform Pedicle Screw SystemPrecision Spine, Inc.201519—
+6K150184Dymaxeon Spine SystemBack 2 Basics Direct, LLC201541
+6K142835Iliad Pedicle Screw System and Zenius Pedicle Screw SystemMedyssey USA, Inc.20155—
+6K150552ELLIPSE and PROTEX CT OCCIPITO-CERVICO-THORACIC SPINAL SYSTEMSGlobus Medical, Inc.2015961
+6K150283Republic Spine Dark Star Spinal SystemRepublic Spine, LLC20154—
+6K150647Polyscrew Pedicle Screw SystemNew Era Orthopedics, LLC201501
+6K141222Nautilus Spinal System and Solstice Oct SystemLife Spine, Inc.201513—
+6K143633CREO Stabilization SystemGlobus Medical, Inc.2015158—
+6K141253New Era Orthopaedics Polyscrew Pedicle Screw SystemNew Era Orthopaedics, LLC201511
+6K142146Ibis Pedicle Screw SystemOrtho Development Corp.20145—
+6K142185Expedium Verse Spine SystemDepuy Spine, Inc.201420—
+6K132049Thunderbolt and Lancer Pedicle Screw SystemsChoicespine201482—
+6K140529Everest Spinal SystemK2m, LLC201431—
+6K140123Polaris Spinal System -Translation ScrewEbi, LLC2014221
+6K133366Orthros Posterior Stabilization SystemCamber Spine20142—
+6K133746Polaris Spinal SystemBiomet Spine (Aka Ebi, LLC)2014671
+6K131615Polaris Spinal SystemBiomet Spine (Aka Ebi, LLC)201370—
+6K131785Pagoda Pedicle Screw SystemOrtho Development Corp.20136—
+6K131030Range Spinal SystemK2m, Inc.201334—
+6K130330Range Spinal SystemK2m, Inc.201336—
+6K121786Dymaxeon Spine SystemB2b Spine Pty, Ltd.20125—
+6K121016Range Spinal System (Mesa and Denali)K2m, Inc.201238—
+6K121130Polaris Spinal System-Ballista Spinal RodsBiomet Spine20121—
+6K120899Range Spinal System, Unit RodK2m, Inc.201235—
+6K120928Synthes Matrix SystemSynthes Spine20120—
+6K120656Everest Spinal SystemK2m, Inc.201243—
+6K110896Reliance Spinal Screw SystemReliance Medical Systems, LLC20125—
+6K111571Viper SystemsJohnson & Johnson2011203—
+6K101993Viper System, Expedium SystemDepuy Spine, Inc.20101628
+6K101112Reliance Spinal Screw SystemReliance Medical Systems20107—
+6K081978Reliance Spinal Screw SystemReliance Medical Systems, LLC20098—
+6K073430Valeo Pedicle Screw Spinal SystemAmedica Corp.200824—
+7K262067iFuse Granite Onyx™ Implant SystemSI-BONE, Inc.20260—
+7K253966PERLA® TL Posterior Thoraco-lumbar Fixation SystemSpineart SA20260—
+7K254274ARx® SAI Implant SystemLife Spine, Inc.20260—
+7K254045CarboClear® Posterior Cervical Screw System; CarboClear® Hybrid Posterior Cervical Screw…CarboFix Orthopedics, Ltd.20260—
+7K254148VERTICALE GPS InstrumentsSilony Medical GmbH20260—
+7K252327CMORE® CT System; CMORE® CT System Navigated InstrumentsIcotec AG20251—
+7K252088Firebird SI Navigation SystemOrthofix US, LLC20251—
+7K252322SIros-X SystemGenesys Spine20250—
+7K252346OLYMPIC Posterior Spinal Fixation System; MASADA Modular Spinal Fixation SystemAstura Medical20250—
+7K253094iFuse Bedrock Granite Implant SystemSI-BONE, Inc.20250—
+7K251780iGPS Navigation InstrumentsSI-BONE, Inc.20250—
+7K252437JAZZ Spinal SystemImplanet20250—
+7K251073Innovasis Navigation Instruments (Vector G-E Navigation Instruments and the Excella G-E…Innovasis, Inc.202501
+7K241525ExcelsiusXR™Globus Medical, Inc.20250—
+7K243326Dynamis Robotic Surgical SystemLEM Surgical AG20251—
+7K243514Salvo® Robotic Navigation InstrumentsSpine Wave, Inc.20250—
+7K243916Primus Spinal Fixation SystemSpinal Elements, Inc.20252—
+7K243908Tiger 2 SystemZavation Medical Products, LLC20251—
+7K243814NuVasive Pulse SystemGlobus Medical, Inc.20250—
+7K243671ExcelsiusGPS® InstrumentsGlobus Medical, Inc.20240—
+7K242297Reform Pedicle Screw SystemPrecision Spine, Inc.20240—
+7K242764MediRod Pedicle Screw SystemCmf Medicon Surgical, Inc.20240—
+7K240160EGPS Navigated InstrumentsAstura Medical20240—
+7K241464ARx® SAI Implant SystemLife Spine, Inc.20241—
+7K241863Erisma® Lp Spinal Fixation System; Erisma® LP MISClariance20240—
+7K241519Invictus® Small Stature Spinal Fixation SystemAlphatec Spine, Inc.20242—
+7K233256Robotic Integration InstrumentsDePuy Synthes20240—
+7K240721ExcelsiusFlex™Globus Medical, Inc.20240—
+7K240951Invictus Robotic Navigation InstrumentsAlphatec Spine20242—
+7K240392JAZZ Spinal SystemImplanet20241—
+7K240568DuraPro™ Oscillating SystemGlobus Medical, Inc.20240—
+7K231850QUARTEX® Occipito-Cervico-Thoracic Spinal System ExcelsiusGPS® InstrumentsGlobus Medical, Inc.20242—
+7K233638VERZA™ High Speed DrillsGlobus Medical, Inc.20241—
+7K233455ARx MIS Spinal Screw SystemLife Spine, Inc.20230—
+7K233332Statera-C™ Spinal SystemK&J Consulting Corp.20230—
+7K232292Peridot-EX Expandable Intervertebral Body Fusion SystemGbs Commonwealth Co., Ltd.20230—
+7K232044Invictus Robotic Navigation InstrumentsAlphatec Spine, Inc.20233—
+7K230774PERLA® TL System; TEKTONA® HV US Bone CementSpineart20230—
+7K223558CUVIS-spineCurexo, Inc.20230—
+7K222229Advanced LumFix Spinal Fixation SystemCG Bio Co., Ltd.20232—
+7K223350Remi Robotic Navigation SystemFusion Robotics, LLC20230—
+7K222789VADER® Pedicle System, G21 CementIcotec AG202352
+7K221926Invictus® Bone Cement, Invictus Spinal Fixation SystemAlphatec Spine, Inc.202214—
+7K213196MARVEL™ Growing RodsGlobus Medical, Inc.20220—
+7K221403Cortera Spinal Fixation SystemSurgalign Spine Technologies202232
+7K213935PISCES-SA Standalone ALIF Interbody SystemOsseus Fusion Systems202212—
+7K220025ARx® Spinal SystemLife Spine, Inc.20220—
+7K213750VyLink™ Spinal Screw SystemVy Spine, LLC20221—
+7K213470PERLA® TL Posterior Osteosynthesis SystemSpineart20222—