510(k) Report

Devices descending from K993030

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

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+7K213281PASS LP™ Spinal System, CD Horizon™ Spinal SystemMedicrea International SA20220—
+7K211616ExcelsiusHubGlobus Medical, Inc.20219Class I
+7K203023Pisces Spinal SystemOrtho Development Corporation20210—
+7K201569CUVIS-spineCurexo, Inc.20212—
+7K202184Practical Navigation Surgical Guidance System (PNSGS)Practical Navigation, LLC20215—
+7K203319SYMPHONY™ OCT SystemMedos International SARL20211—
+7K200922Altus Spine HA Pedicle Screw SystemAltus Partners, LLC20213—
+7K203506PERLA® TL posterior osteosynthesis systemSpineart202132
+7K203125Invictus™ OCT Spinal Fixation SystemAlphatec Spine, Inc.20200—
+7K203222PERLA TL Posterior Osteosynthesis SystemSpineart20204—
+7K203056Invictus™ Spinal Fixation SystemAlphatec Spine, Inc.202061—
+7K202327Invictus™ OsseoScrew® SystemAlphatec Spine, Inc.20200—
+7K200047ExcelsiusGPS Cranial 1.0 ModuleGlobus Medical, Inc.202053
+7K200936Invictus™ CT Spinal Fixation SystemAlphatec Spine, Inc.20203—
+7K200303Reform Pedicle Screw SystemPrecision Spine202010—
+7K192930Dymaxeon Spine SystemBack 2 Basics Direct, LLC20201—
+7K200245EXPEDIUM® Spine System; EXPEDIUM VERSE® Spine SystemMedos International Sàrl202012—
+7K191810Curiteva Pedicle Screw SystemCuriteva, Inc.20190—
+7K191100ExcelsiusGPS Spine 1.1 Interbody ModuleGlobus Medical, Inc.201942—
+7K191045Salvo™ Spine SystemSpine Wave, Inc.20195—
+7K182544AccelFix Spinal Fixation SystemL&K BIOMED Co., Ltd.201910—
+7K183119SI-LOK® Sacroiliac Joint Fixation System, Navigation Instruments, ExcelsiusGPS®…Globus Medical, Inc.20192—
+7K182000AQrate Robotic Assistance SystemGlobus Medical, Inc.20191—
+7K182721Choice Spine Navigation SystemChoicespine, LP20192—
+7K183168OpenLoc-L Spinal Fixation SystemL&K BIOMED Co., Ltd.201823—
+7K183080Mega Plus Spine SystemBk Meditech, Co., Ltd.20182—
+7K180754C-Zero Pedicle Screw System, Freedom Pedicle Screw SystemSignature Orthopaedics Pty, Ltd.20180—
+7K182508Saxxony™ Posterior Cervical Thoracic SystemNexxt Spine, LLC20184—
+7K181495Republic Spine Dark Star Spinal SystemRepublic Spine, LLC20183—
+7K181350ASTRA-OCT Spine SystemSpinecraft, LLC20180—
+7K161225Paonan Armstrong Posterior Spinal Fixation SystemPaonan Biotech Co., Ltd.20172—
+7K171509Iliad® Pedicle Screw System and Zenius® Pedicle Screw SystemMedyssey USA, Inc.20171—
+7K170989Dymaxeon Spine SystemBack 2 Basics Direct, LLC20172—
+7K170942The Thunderbolt™ Minimally Invasive and Lancer™ Open Pedicle Screw SystemsChoicespine, LP20170—
+7K162995Ibis® Pedicle Screw SystemOrtho Development Corporation20173—
+7K162066Reliance Spinal Screw SystemReliance Medical Systems, LLC20163—
+7K162160Preference Elite Pedicle Screw SystemAmedica Corporation20161—
+7K161591QUARTEX™ Occipito-Cervico-Thoracic Spinal System, Globus Navigation InstrumentsGlobus Medical, Inc.201678—
+7K160775Thunderbolt™ Minimally Invasive and Lancer™ Open Pedicle Screw SystemsChoicespine, LP201673—
+7K153370Caspian OCT/MESA Mini/DENALI Mini Spinal SystemK2m, Incorporated201617—
+7K153031RANGE/DENALI/MESA Spinal SystemK2m, Incorporated20152—
+7K151974Polaris Spinal SystemBiomet Spine201516—
+7K152131Reliance Spinal Screw SystemReliance Medical Systems, LLC20154—
+7K150896Vitality Spinal Fixation SystemZimmer Spine, Inc.2015193
+7K150380ProMIS Fixation SystemPremia Spine, Ltd.20154—
+7K151196Nautilus Spinal SystemLife Spine, Inc.201512—
+7K142360Everest Spinal SystemK2m, Inc.201522—
+7K143334Range/Denali/Mesa Spinal SystemK2m, Inc.201516—
+7K143248Reform Pedicle Screw SystemPrecision Spine, Inc.201430—
+7K140765Range/Mesa/Denali Spinal SystemK2m, Inc.201415—
+7K141147Range Spinal SystemK2m, Inc.20141—
+7K133944Range, Spinal System, Everest Spinal SystemK2m, Inc.201433—
+7K132757Everest Spinal SystemK2m, Inc.201341—
+7K132361Everest Spinal SystemK2m, Inc.201334—
+7K131802Expedium, Viper. Viper 2 Spine SystemDepuy Spine, A Johnson & Johnson Company2013139—
+7K131784Range Spinal SystemK2m, Inc.201334—
+7K131810Osseus Black Diamond Pedicle Screw SystemOsseus Fusion Systems, LLC201314—
+7K123521Reliance Spinal Screw SystemReliance Medical Systems, LLC20135—
+7K123451Polaris Spinal System - Ballista II RodsBiomet Spine (Aka Ebi, LLC)20120—
+7K121728Tiger Spine SystemCorelink, LLC201250—
+7K121172Reform Pedicle Screw SystemSpinal USA201233—
+7K121020Viper SystemDepuy Spine, Inc.201294—
+7K120696Tiger Spine SystemCorelink, LLC201241—
+7K080767Conquest Spinal SystemLife Spine200821—
+8K262828KHEIRON® Spinal Fixation System, including patient specific K-RODS.M.A.I.O20260—
+8K253943Tiger 2 SystemZavation Medical Products, LLC20260—
+8K261284Invictus® Small Stature Spinal Fixation System; Invictus® 2.0 Spinal Fixation SystemAlphatec Spine, Inc.20260—
+8K260369Dynamis Robotic Surgical SystemLEM Surgical AG20260—
+8K261665CORUS™ Navigation System-GNProvidence Medical Technology, Inc.20260—
+8K260571SIMPACT Sacroiliac Joint Fixation System GX Navigation InstrumentsLife Spine, Inc.20260—
+8K253615Invictus Bands SystemAlphatec Spine, Inc.20260—
+8K252597Valence Robotic Navigation System; Valence Robotic Navigation Instruments (For Use with…Alphatec Spine, Inc.20261—
+8K253990KHEIRON® Spinal Fixation System, including patient specific K-RODS.M.A.I.O20262—
+8K250599ExcelsiusGPS™ InstrumentsGlobus Medical, Inc.20250—
+8K253249TriALTIS™ Spine SystemMedos International SARL20251—
+8K242827A8 INTEGR8™ Porous Pedicle ScrewsAllumin8, Inc.20251—
+8K251060CORUS™ Navigation System-GXProvidence Medical Technology, Inc.20250—
+8K250845Curiteva Porous PEEK Standalone ALIF SystemCuriteva, Inc.20251—
+8K251154RIVA Posterior Fixation System; RIVA Posterior Fixation System Navigation InstrumentsHt Medical D.B.A. Xenix Medical20251—
+8K242674Freedom Posterior Cervical ScrewsSignature Orthopaedics Pty, Ltd.20250—
+8K250582COLONNADE Posterior Screw Fixation SystemCG Bio Co., Ltd.20250—
+8K242516EUROPA™ Posterior Cervical Fusion SystemMiRus, LLC20242—
+8K230325GREENS BRAND Posterior, Non-cervical Pedicle Screw Spinal SystemGreens Surgicals Pvt., Ltd.20240—
+8K240326Solar™ Lumbar Interbody Fusion SystemDegen Medical, Inc.20244—
+8K233228Spine Navigation and Robotic-Assistance DeviceEcential Robotics202421
+8K232628VADER® Pedicle SystemIcotec AG20241—
+8K231923Liberty SI Lateral Implant SystemSpinal Simplicity, LLC20230—
+8K233366SYMPHONY OCT SystemMedos International SARL20230—
+8K231744VyLink™ Spinal Screw SystemVy Spine, LLC20230—
+8K232275Invictus® Spinal Fixation SystemAlphatec Spine, Inc.202311—
+8K231844ProMIS™ Fixation SystemPremia Spine, Ltd.20231—
+8K231199Solar Lumbar Interbody Fusion SystemDegen Medical20235—
+8K230721ATEC Lateral Plate SystemAlphatec Spine, Inc.20230—
+8K223413Pisces™-SA STANDALONE ALIF Interbody SystemOsseus Fusion Systems20233—
+8K223070Remi Robotic Navigation SystemFusion Robotics, LLC20224—
+8K222270HEDRON Cervical Spacers, HEDRON Lumbar Spacers, SABLE Expandable Spacer, ExcelsiusGPS…Globus Medical, Inc.202223—
+8K222473EXPEDIUM® Spine System, EXPEDIUM VERSE® Spine System: ALTALYNE™ Ultra RodsMedos-International Sarl20221—
+8K222698CUVIS-spineCurexo, Inc.20220—
+8K211027Altus Spine Pedicle Screw SystemAltus Partners, LLC20222—
+8K212962TRELLIS™ SI Joint Fusion SystemOrthofundamentals, LLC20220—