510(k) Report

Devices descending from K993030

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

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+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—
+5K173130Reform® Midline Cortical Screw SystemPrecision Spine, Inc.201721—
+5K172194Connector SystemOrthofix, Inc.2017162
+5K170821ChoiceSpine™ Proliant® Posterior Pedicle Screw and Hook Fixation SystemChoicespine, LP20170—
+5K170266Palisade™ Pedicular Fixation SystemSpineology, Inc.20172—
+5K170255Threshold™ V2 Pedicular Fixation SystemSpineology, Inc.20171—
+5K170251Threshold™ Pedicular Fixation SystemSpineology, Inc.20171—
+5K170268Fortress™ Pedicular Fixation SystemSpineology, Inc.20171—
+5K170163Erisma® LP Spinal Fixation SystemClariance, Sas20172—
+5K162786PASS LP Spinal SystemMedicrea International SA20176—
+5K162134ENNOVATE Spinal SystemAesculap Implant Systems, LLC20162—
+5K153453Inertia Pedicle Screw and Deformity Correxxion SystemNexxt Spine, LLC201617—
+5K160124LUMIS Cannulated Pedicle Screw Fixation System, U.L.I.S. Pedicle Screw Fixation SystemSpinevision S.A.20162—
+5K153326Erisma-LP Spinal Fixation SystemClariance, Sas201651
+5K151770Libra Pedicle Screw SystemSpinal Balance, Inc.20151—
+5K143363VENUS Spinal Fixation SystemL&K BIOMED Co., Ltd.201533—
+5K141804Polaris Spinal System - HA CoatedBiomet Spine, LLC201421—
+5K141291Vertiform Posterior Fixation SystemNext Orthosurgical20142—
+5K133575Spinevision Lumis Cannulated Pedicle Screw Fixation System, Spinevision U.L.I.S. Pedicle…Spinevision S.A.20143—
+5K133350Revere Stabilization SystemGlobus Medical, Inc.201493—
+5K132403Annextm Adjacent Level SystemSpine Wave, Inc.20142—
+5K132644Lospa IS Pedicle Screw (Monoaxial & Polyaxial), Lospa IS Rod- Straight (Standard), Lospa…Corentec Co., Ltd.20130—
+5K124058Creo Stabilization SystemGlobus Medical, Inc.2013172—
+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
+5K113058Tiger Spine SystemCorelink, LLC201281—
+5K113396Depuy Pulse Thoracolumbar Screw SystemMedos International SARL20121—
+5K112920Range Spinal System (Mesa and Denali)K2m, Inc.201149—
+5K110216Expedium System, Viper SystemDepuy Spine, Inc.20114—
+5K103133Veper System, Expedium SystemDepuy Spine, Inc.20110—
+5K102249Expedium Spine SystemDepuy Spine, A Johnson & Johnson Company2010218—
+5K102204Choice Spine Starfire Pedicle Screw SystemChoicespine, LP201088—
+5K073562Modification to Viper Spine SystemDepuy Spine, Inc.2008213—
+5K080313Modification to Expedium Spine SystemDepuy Spine, Inc.2008397—
+5K070387Expedium Spine SystemDepuy Spine, Inc.2007248—
+5K063741Expedium Spine SystemDepuy Spine, Inc.2007398—
+5K063156Modification to Expedium Spine SystemDepuy Spine, Inc.2006424—
+6K251251ChanPin Pedicle Screw Spinal SystemChanpin Medtak Co., Ltd.20260—
+6K253739SCRIPT™ Rods, CREO™ Stabilization System, REVERE® Stabilization System, REVERE® 4.5…Globus Medical, Inc.20260—
+6K261130AccelFix Spinal Fixation SystemL&K BIOMED Co., Ltd.20260—
+6K253940M.U.S.T. Pedicle Screw System - ExtensionMedacta International S.A.20260—
+6K254247Osteomni Spinal Fixation SystemOsteomni, Inc.20260—
+6K253545Vulcan Spinal SystemK2m, Inc.20260—
+6K250520OsteoCentric Navigated Instruments SystemOsteocentric Technologies, Inc.20250—
+6K251719Momentum® Posterior Spinal Fixation SystemUlrich Medical USA, Inc.20250—
+6K251131Annex® 2 Adjacent Level SystemSpine Wave, Inc.20250—
+6K243419Altus Spine Navigation SystemAltus Partners, LLC20250—
+6K243259MASADA Modular Spinal Fixation SystemAstura Medical20250—
+6K243281LOCK-IN Spinal Fixation SystemLock-In USA Corp20240—
+6K242899NOVA Minimally Invasive SystemBaui Biotech Co., Ltd.20240—
+6K242069Eminent Spine Scoliosis Deformity Pedicle Screw SystemEminent Spine20240—
+6K240872Erisma® Deformity Spinal System; Erisma® Lp Spinal Fixation SystemClariance20241—
+6K240846CarboClear® Hybrid Pedicle Screw System; CarboClear® Hybrid Navigated Instruments…CarboFix Orthopedics, Ltd.20242—
+6K233989CarboClear® Posterior Cervical Screw SystemCarboFix Orthopedics, Ltd.20242—
+6K233508iFuse Bedrock Granite® Implant SystemSI-BONE, Inc.20245—
+6K232719ProMIS Extension Rod SystemPremia Spine, Ltd.20230—
+6K231694MASADA Modular Spinal Fixation SystemAstura Medical20232—
+6K233443Vital™ Navigation SystemZimvie Spine (Zimmer Biomet Spine, Inc.)20230—
+6K231069PERLA® TL Posterior Thoraco-lumbar Fixation SystemSpineart SA20231—
+6K232586Rexious Spinal Fixation System, Statera™ Spinal System, Statera-M™ Spinal SystemK&J Consulting Corp.20230—
+6K231809Momentum® Posterior Spinal Fixation System with G21 V-STEADY Bone Cement; Momentum® MIS…Ulrich Medical USA20231—
+6K230961Zeus Spinal SystemShanghai Sanyou Medical Co, Ltd.20232—
+6K231658VEOS Spinal Fixation SystemSpineway20230—
+6K231799INERTIA® CONNEXX™ Modular Pedicle Screw SystemNexxt Spine, LLC20230—
+6K231280CarboClear® X Pedicle Screw System; CarboClear® X Navigated Instruments; CarboClear® X…CarboFix Orthopedics, Ltd.20234—
+6K230880CoreLink Navigation InstrumentsCorelink, LLC20230—
+6K230063G Surgical Marksman Spinal Deformity SystemG Surgical, LLC20230—
+6K222614Zavation Spinal SystemZavation Medical Products, LLC20223—
+6K222516Mercury® II Spinal SystemSpinal Elements, Inc.20223—
+6K221905INERTIA CONNEXX Modular Pedicle Screw SystemNexxt Spine, LLC20221—
+6K220862E-GPS Navigated InstrumentsPrecision Spine, Inc.20227—
+6K220341ARx Modular Spinal SystemLife Spine, Inc.20221—
+6K220038Camber Spine Navigation SystemCamber Spine Technologies20220—
+6K213720Vital Navigation SystemZimvie (Zimmer Biomet Spine, Inc.)20220—
+6K212066Adena-Zina SystemShanghai Sanyou Medical Co, Ltd.20213—
+6K211710Ascent POCT System, Centurion POCT System, Spinal Fixation System (SFS), Firebird Spinal…Orthofix, Inc.20212—
+6K211113Zavation Spinal SystemZavation Medical Products, LLC20214—
+6K210874Reliance Spinal Screw SystemReliance Medical Systems, LLC20212—
+6K210275Polaris Spinal SystemZimmer Biomet Spine, Inc.20210—
+6K203153CREO Stabilization System, Navigation Instruments, ExcelsiusGPSGlobus Medical, Inc.20211—
+6K203452Nano FortiFix® SystemNanovis, LLC20200—
+6K203163ARx Illiac Spinal Screw SystemLife Spine, Inc.20205—
+6K200937ACURA Stabilization SystemIndius Medical Technologies Pvt., Ltd.20200—
+6K200596G21 Cement, VADER® Pedicle SystemIcotec AG2020271
+6K201926CarboClear® Pedicle Screw System, CarboClear® II Pedicle Screw SystemCarboFix Orthopedics, Ltd.202010—
+6K201251CarboClear Navigated InstrumentsCarboFix Orthopedics, Ltd.20209—
+6K193423VADER®one Pedicle System MIS and LightMore® Pedicle System 6.0Icotec AG202061
+6K200267LOSPA® IS™ Spinal Fixation SystemCorentec Co., Ltd.20201—
+6K193472OrthoCircle Spine Pedicle Screw SystemOrthocircle Spine20200—
+6K193396PERLA® TL posterior osteosynthesis systemSpineart202072
+6K190981NEX-D2 Posterior Fixation SystemNext Orthosurgical20200—
+6K192938Invictus™ Spinal Fixation SystemAlphatec Spine, Inc.201969—
+6K192121Black Diamond Pedicle Screw SystemOsseus Fusion Systems201913—
+6K190526High V+ Bone Cement, CarboClear® Fenestrated Pedicle ScrewsCarboFix Orthopedics, Ltd.201928—
+6K191835CREO Stabilization System, Navigation Instruments, ExcelsiusGPS InstrumentsGlobus Medical, Inc.20192—
+6K190545VADER® one Pedicle System MIS and LightMore® Pedicle System 6.0Icotec AG2019291
+6K190762The JASPER Spinal Fixation System IIGbs Commonwealth Co., Ltd.20191—