510(k) Report

Devices descending from K944756

491 later devices reach Isola Open and Closed Screws through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+5K171421VERTICALE® Posterior Spinal Fixation System/VERTICALE® SystemSilony Medical GmbH20186—
+5K171832Range/Denali/Mesa Spinal SystemK2m, Inc.201713—
+5K171582NEO Pedicle Screw System™Neo Medical SA20170—
+5K171321K2M Navigation InstrumentsK2m201711
+5K172107Threshold™ V2 Pedicular Fixation System, Threshold™ Pedicular Fixation System, Fortress™…Spineology, Inc.20170—
+5K171651Excelsius GPSGlobus Medical, Inc.2017691
+5K161225Paonan Armstrong Posterior Spinal Fixation SystemPaonan Biotech Co., Ltd.20172—
+5K171438Palisade™ Pedicular Fixation SystemSpineology, Inc.20171—
+5K170061ProMIS™ Fixation SystemPremia Spine, Ltd.20170—
+5K161387Mont Blanc and Mont Blanc MIS Spinal SystemsSpineway SA20163—
+5K153442CD HORIZON Spinal System, Medtronic Navigated Manual Reusable Instruments for Use with…Medtronic Sofamor Danek USA, Inc.201684—
+5K151727Everest Spinal SystemK2m, Inc.201511—
+5K151422Reform Pedicle Screw SystemPrecision Spine, Inc.201519—
+5K151216Everest Spinal SystemK2m, Inc.201511—
+5K150856Reform Pedicle Screw SystemPrecision Spine, Inc.201526—
+5K150552ELLIPSE and PROTEX CT OCCIPITO-CERVICO-THORACIC SPINAL SYSTEMSGlobus Medical, Inc.2015961
+5K150417Astra Spine SystemSpinecraft, LLC201521—
+5K150647Polyscrew Pedicle Screw SystemNew Era Orthopedics, LLC201501
+5K150325Range/Denali/Mesa Spinal SystemK2m, Inc.201512—
+5K141222Nautilus Spinal System and Solstice Oct SystemLife Spine, Inc.201513—
+5K143200MIS Z-Pedicle Screw SystemZ-Medical GmbH & Co. KG201514—
+5K143633CREO Stabilization SystemGlobus Medical, Inc.2015158—
+5K141253New Era Orthopaedics Polyscrew Pedicle Screw SystemNew Era Orthopaedics, LLC201511
+5K143248Reform Pedicle Screw SystemPrecision Spine, Inc.201430—
+5K141873Range/Mesa/Denali Spinal SystemK2m, Inc.201430—
+5K133402K2M Modular HooksK2m, Inc.20140—
+5K133366Orthros Posterior Stabilization SystemCamber Spine20142—
+5K131538Caplox II Pedicle Screw System/Towerlox Pedicle Screw SystemCaptiva Spine20136—
+5K131343Reform Pedicle Screw SystemSpinal USA201331—
+5K130279Reform Pedicle Screw SystemSpinal USA201331—
+5K123487Gso GS1 Cannulated Screw SystemGold Standard Orthopaedics, LLC20130—
+5K123373Nautilus Spinal SystemLife Spine201317—
+5K111953Nautilus Spinal SystemLife Spine20123—
+5K090320Conquest Spinal SystemLife Spine20092—
+6K262067iFuse Granite Onyx™ Implant SystemSI-BONE, Inc.20260—
+6K253943Tiger 2 SystemZavation Medical Products, LLC20260—
+6K253045“Socko” Vimax Spinal Fixation SystemSocko Medical Co., Ltd.20260—
+6K253940M.U.S.T. Pedicle Screw System - ExtensionMedacta International S.A.20260—
+6K260786KHEIRON® Spinal Fixation System, including patient specific K-RODS.M.A.I.O20261—
+6K254045CarboClear® Posterior Cervical Screw System; CarboClear® Hybrid Posterior Cervical Screw…CarboFix Orthopedics, Ltd.20260—
+6K254148VERTICALE GPS InstrumentsSilony Medical GmbH20260—
+6K252729Universal Spinal SystemDouble Medical Technology, Inc.20250—
+6K252327CMORE® CT System; CMORE® CT System Navigated InstrumentsIcotec AG20251—
+6K250520OsteoCentric Navigated Instruments SystemOsteocentric Technologies, Inc.20250—
+6K252322SIros-X SystemGenesys Spine20250—
+6K251780iGPS Navigation InstrumentsSI-BONE, Inc.20250—
+6K251073Innovasis Navigation Instruments (Vector G-E Navigation Instruments and the Excella G-E…Innovasis, Inc.202501
+6K241525ExcelsiusXR™Globus Medical, Inc.20250—
+6K250845Curiteva Porous PEEK Standalone ALIF SystemCuriteva, Inc.20251—
+6K243419Altus Spine Navigation SystemAltus Partners, LLC20250—
+6K243326Dynamis Robotic Surgical SystemLEM Surgical AG20251—
+6K243514Salvo® Robotic Navigation InstrumentsSpine Wave, Inc.20250—
+6K243814NuVasive Pulse SystemGlobus Medical, Inc.20250—
+6K243671ExcelsiusGPS® InstrumentsGlobus Medical, Inc.20240—
+6K242297Reform Pedicle Screw SystemPrecision Spine, Inc.20240—
+6K242764MediRod Pedicle Screw SystemCmf Medicon Surgical, Inc.20240—
+6K240160EGPS Navigated InstrumentsAstura Medical20240—
+6K240326Solar™ Lumbar Interbody Fusion SystemDegen Medical, Inc.20244—
+6K241519Invictus® Small Stature Spinal Fixation SystemAlphatec Spine, Inc.20242—
+6K240721ExcelsiusFlex™Globus Medical, Inc.20240—
+6K240951Invictus Robotic Navigation InstrumentsAlphatec Spine20242—
+6K240568DuraPro™ Oscillating SystemGlobus Medical, Inc.20240—
+6K233951CD Horizon ModuLeX Spinal System (Shanks, Head Assemblies, and Set Screw)Medtronic Sofamor Danek USA, Inc.20245—
+6K231850QUARTEX® Occipito-Cervico-Thoracic Spinal System ExcelsiusGPS® InstrumentsGlobus Medical, Inc.20242—
+6K233638VERZA™ High Speed DrillsGlobus Medical, Inc.20241—
+6K233455ARx MIS Spinal Screw SystemLife Spine, Inc.20230—
+6K233332Statera-C™ Spinal SystemK&J Consulting Corp.20230—
+6K232044Invictus Robotic Navigation InstrumentsAlphatec Spine, Inc.20233—
+6K231479TriALTIS Spine SystemMedos International SARL20238—
+6K223301ASTRA & AVANT Navigation Instruments System and ASTRA-OCT Navigation Instruments SystemSpinecraft, LLC20230—
+6K223806VERTICALE® Triangular Fixation SystemSilony Medical GmbH20230—
+6K231636LnK Spinal Fixation System /OpenLoc-L Spinal Fixation System, AccelFix Spinal Fixation…L&K BIOMED Co., Ltd.20232—
+6K230774PERLA® TL System; TEKTONA® HV US Bone CementSpineart20230—
+6K223558CUVIS-spineCurexo, Inc.20230—
+6K231199Solar Lumbar Interbody Fusion SystemDegen Medical20235—
+6K223096Dark Star Deformity Pedicle Screw SystemRepublic Spine, LLC20231—
+6K230880CoreLink Navigation InstrumentsCorelink, LLC20230—
+6K230766Altus Spine Monaco Pedicle Screw SystemAltus Spine20231—
+6K223350Remi Robotic Navigation SystemFusion Robotics, LLC20230—
+6K230245LnK Spinal Fixation System/OpenLoc-L Spinal Fixation System; AccelFix Spinal Fixation…L&K BIOMED Co., Ltd.20233—
+6K223413Pisces™-SA STANDALONE ALIF Interbody SystemOsseus Fusion Systems20233—
+6K222789VADER® Pedicle System, G21 CementIcotec AG202352
+6K223273ASTRA Spine SystemSpinecraft, LLC20228—
+6K221926Invictus® Bone Cement, Invictus Spinal Fixation SystemAlphatec Spine, Inc.202214—
+6K213196MARVEL™ Growing RodsGlobus Medical, Inc.20220—
+6K211027Altus Spine Pedicle Screw SystemAltus Partners, LLC20222—
+6K222256BonOs® Inject Bone Cement; NEO Pedicle Screw System™Neo Medical SA20223—
+6K221403Cortera Spinal Fixation SystemSurgalign Spine Technologies202232
+6K220862E-GPS Navigated InstrumentsPrecision Spine, Inc.20227—
+6K220024ChoiceSpine Navigation SystemChoice Spine, LLC20220—
+6K221244CD Horizon™ Spinal SystemMedtronic202220—
+6K213491Universal Pilot Guidance Instrument SystemCtl Medical Corporation20220—
+6K220038Camber Spine Navigation SystemCamber Spine Technologies20220—
+6K220025ARx® Spinal SystemLife Spine, Inc.20220—
+6K211616ExcelsiusHubGlobus Medical, Inc.20219Class I
+6K202836GX Navigation Instrument SystemLife Spine, Inc.20211—
+6K211323ASTRA Spine SystemSpinecraft, LLC202112—
+6K201569CUVIS-spineCurexo, Inc.20212—
+6K210549ARx Spinal SystemLife Spine, Inc.20211—
+6K202184Practical Navigation Surgical Guidance System (PNSGS)Practical Navigation, LLC20215—