510(k) Report

Devices descending from K043565

834 later devices reach Modification to Dynesys Spinal System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+6K122332Towerlox Pedicle Screw SystemCaptiva Spine201214—
+6K122862CD Horizon Spinal SystemMedtronic Sofamor Danek USA, Inc.2012211—
+6K122433CD Horizon Spinal SystemMedtronic Sofamor Danek, Inc.201239—
+6K121630Range Spinal SystemK2m, Inc.2012127—
+6K120838Synthes Matrix SystemSynthes Spine201216—
+6K121115M.U.S.T Pedicle Screw SystemMedacta International2012431
+6K120564Calypso SystemHogan Lovells US LLP201216—
+6K121342Xia 4.5 Spinal SystemStryker Corp.201288—
+6K113395Revere 4.5 Stabilization SystemGlobus Medical, Inc.2012260—
+6K120928Synthes Matrix SystemSynthes Spine20120—
+7K263172SAS MIS Pelvic Incidence RodsSpinal Alignment Solutions, Inc.20260—
+7K262067iFuse Granite Onyx™ Implant SystemSI-BONE, Inc.20260—
+7K262193RIVA® Posterior Fixation System with NanoACTIV Surface Technology; RIVA® Anchor…Xenix Medical20260—
+7K261809Interwedge® Standalone LateralFoundation Surgical Group20260—
+7K261020Symmetrix™ L Spinal SystemMedtronic Sofamor Danek USA, Inc.20260—
+7K261284Invictus® Small Stature Spinal Fixation System; Invictus® 2.0 Spinal Fixation SystemAlphatec Spine, Inc.20260—
+7K253802KHEIRON® Spinal Fixation System, including patient specific K-RODS.M.A.I.O20261—
+7K260989Varion Thoracolumbar Fixation SystemKyocera Medical Technologies Inc. (KMTI)20260—
+7K252542LEO Spinal SystemZheJiang Decans Medical Devices Co., Ltd.20260—
+7K260011Foundation Surgical Navigated Lateral Disc Prep InstrumentsFoundation Surgical Group, Inc.20260—
+7K254158SPINEART Navigation Instrument SystemSpineart SA20261—
+7K253615Invictus Bands SystemAlphatec Spine, Inc.20260—
+7K252087Navigation Module of the Cortium® SystemUlrich Medical USA, Inc.20260—
+7K254165Infinity™ OCT SystemMedtronic Sofamor Danek USA, Inc.20260—
+7K252962DYNAMIS™ Navigation SystemPromethean Restorative, LLC20260—
+7K253990KHEIRON® Spinal Fixation System, including patient specific K-RODS.M.A.I.O20262—
+7K253721KHEIRON® Spinal Fixation System, including patient specific K-RODS.M.A.I.O20252—
+7K253093Vital™ Spinal Fixation SystemHighridge Medical, LLC20250—
+7K250599ExcelsiusGPS™ InstrumentsGlobus Medical, Inc.20250—
+7K250520OsteoCentric Navigated Instruments SystemOsteocentric Technologies, Inc.20250—
+7K252322SIros-X SystemGenesys Spine20250—
+7K253331PressON Spinal Fixation SystemNexus Spine20250—
+7K251804KHEIRON® Spinal Fixation System, including patient specific K-RODS.M.A.I.O20254—
+7K251431FIX-C PEEK ACIF SA SystemJeil Medical Corporation20250—
+7K242933SPINEART Navigation Instrument SystemSpineart SA20252—
+7K243419Altus Spine Navigation SystemAltus Partners, LLC20250—
+7K250182Innovasis Navigation InstrumentsInnovasis, Inc.202521
+7K242900VADER® Pedicle System and VADER®one Pedicle SystemIcotec AG20250—
+7K243259MASADA Modular Spinal Fixation SystemAstura Medical20250—
+7K242297Reform Pedicle Screw SystemPrecision Spine, Inc.20240—
+7K230325GREENS BRAND Posterior, Non-cervical Pedicle Screw Spinal SystemGreens Surgicals Pvt., Ltd.20240—
+7K234035COSINE™ SpacerGlobus Medical, Inc.20240—
+7K241164IB3D™ PL Spinal SystemMedicrea International S.A.S. (Medtronic)202412
+7K240180Orthopeasia Spinal Fixation SystemOrthopeasia Co., Ltd.20240—
+7K241644SPINEART Navigation Instrument SystemSpineart SA20243—
+7K241082INNOVERSE Navigation InstrumentsInnosys Co., Ltd.20240—
+7K241034Meta+ Bone Cement & M.U.S.T. Fenestrated Pedicle Screw SystemMedacta International S.A.20242—
+7K241276Vector™ Pedicle Screw SystemInnovasis, Inc.202411
+7K234048M.U.S.T. Pedicle Screw System - ExtensionMedacta International S.A.20241—
+7K233508iFuse Bedrock Granite® Implant SystemSI-BONE, Inc.20245—
+7K233735ADIRA™ Lateral Plate SystemGlobus Medical, Inc.20240—
+7K233455ARx MIS Spinal Screw SystemLife Spine, Inc.20230—
+7K231694MASADA Modular Spinal Fixation SystemAstura Medical20232—
+7K232292Peridot-EX Expandable Intervertebral Body Fusion SystemGbs Commonwealth Co., Ltd.20230—
+7K231494CoreLink Robotic Navigation InstrumentsCorelink, LLC20230—
+7K230961Zeus Spinal SystemShanghai Sanyou Medical Co, Ltd.20232—
+7K232413Fusion Robotic Navigation SystemAlphatec Spine, Inc.20232—
+7K231931Adena-Zina Spinal SystemShanghai Sanyou Medical Co, Ltd.20230—
+7K223301ASTRA & AVANT Navigation Instruments System and ASTRA-OCT Navigation Instruments SystemSpinecraft, LLC20230—
+7K223808Zavation Navigation Instrument SystemZavation Medical Products, LLC20230—
+7K230774PERLA® TL System; TEKTONA® HV US Bone CementSpineart20230—
+7K230936Anatomic PEEK™ Cervical Fusion System with NanotechnologyNanovis, LLC20230—
+7K230880CoreLink Navigation InstrumentsCorelink, LLC20230—
+7K230766Altus Spine Monaco Pedicle Screw SystemAltus Spine20231—
+7K230482Swedge™ Pedicle Screw Fixation SystemSpinal Resources, Inc.20231—
+7K222105RESPONSE 5.5/6.0 Cannulated Screw SystemOrthoPediatrics Corp.20230—
+7K223649VERTICALE® Navigation InstrumentsSilony Medical GmbH20223—
+7K221926Invictus® Bone Cement, Invictus Spinal Fixation SystemAlphatec Spine, Inc.202214—
+7K222455Calibrate LTX Interbody SystemAlphatec Spine, Inc.20228—
+7K221646CD HORIZON™ ASTUTE™ SPINAL SYSTEM; CD HORIZON™ Growth Rod Conversion Set; CD HORIZON™…Medtronic Sofamor Danek USA, Inc.202220—
+7K211027Altus Spine Pedicle Screw SystemAltus Partners, LLC20222—
+7K221776NextGen Pedicle Screw SystemCorelink, LLC20222—
+7K221905INERTIA CONNEXX Modular Pedicle Screw SystemNexxt Spine, LLC20221—
+7K220973CoreLink Navigation InstrumentsCorelink, LLC20221—
+7K221180Anteralign (TM) Spinal System with Titan NanoLOCK Surface Technology Navigated InstrumentsMedtronic Sofamor Danek USA, Inc.20222—
+7K213491Universal Pilot Guidance Instrument SystemCtl Medical Corporation20220—
+7K213935PISCES-SA Standalone ALIF Interbody SystemOsseus Fusion Systems202212—
+7K220038Camber Spine Navigation SystemCamber Spine Technologies20220—
+7K214010Anteralign Spinal System with Titan nanoLOCK Surface TechnologyMedtronic Sofamor Danek USA202249—
+7K220025ARx® Spinal SystemLife Spine, Inc.20220—
+7K214011Catalyft™ PL Expandable Interbody System Navigated Instruments, Anteralign™ TL Spinal…Medtronic Sofamor Danek USA, Inc.20221—
+7K213470PERLA® TL Posterior Osteosynthesis SystemSpineart20222—
+7K212489BonOs Inject Bone Cement; NEO Pedicle Screw SystemNeo Medical SA20215—
+7K212825CoreLink Navigation InstrumentsCorelink, LLC20214—
+7K202836GX Navigation Instrument SystemLife Spine, Inc.20211—
+7K212066Adena-Zina SystemShanghai Sanyou Medical Co, Ltd.20213—
+7K201737Posterior Spinal Fixation SystemShanghai Reach Medical Instrument Co, Ltd.20211—
+7K211323ASTRA Spine SystemSpinecraft, LLC202112—
+7K211057LigaPASS® Spinal System, CD Horizon™ Spinal SystemMedtronic, Inc.20211—
+7K210306GII Spinal Fixation SystemColigne AG20210—
+7K202458BonOs Inject, Pedicle screw kits, Cement pusherOsartis GmbH20216—
+7K210061ProLift Lateral HELO FixatedLife Spine, Inc.20213—
+7K210427M.U.S.T. Midline Cortical (MC) Screw SystemMedacta International S.A.20210—
+7K210716CarboClear X Pedicle Screw System, CarboClear X Navigated InstrumentsCarboFix Orthopedics, Ltd.20218—
+7K203816DeGen Navigated InstrumentationDegen Medical20211—
+7K210472SPINEART Navigation Instrument SystemSpineart20215—
+7K201420Republic Spine Dark Star Spinal SystemRepublic Spine, LLC20212—
+7K203278INDEPENDENCE Spacers, HEDRON IA, MAGNIFY-S Spacers, MONUMENT Spacers, InterContinental…Globus Medical, Inc.202135—
+7K203482M.U.S.T. Pedicle Screw Extension and Long Tab ImplantsMedacta International S.A.20215—
+7K203153CREO Stabilization System, Navigation Instruments, ExcelsiusGPSGlobus Medical, Inc.20211—