510(k) Report

Devices descending from K052054

786 later devices reach TSRH Spinal System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+3K143377PedFuse Pedicle Screw SystemSpinefrontier, Inc.20150—
+3K150178CD Horizon Spinal SystemMedtronic Sofamor Danek USA, Inc.201525—
+3K142360Everest Spinal SystemK2m, Inc.201522—
+3K141253New Era Orthopaedics Polyscrew Pedicle Screw SystemNew Era Orthopaedics, LLC201511
+3K141282PGS 5.5 MM Cannulated Pedicle ScrewPinnacle Spine Group20141—
+3K142591CD HORIZON Spinal SystemMedtronic Sofamor Danek USA, Inc.2014212—
+3K143141CD HORIZON Spinal SystemMedtronic Sofamor Danek USA, Inc.201416—
+3K142847CD HORIZON Spinal SystemMedtronic Sofamor Danck USA, Inc.2014286—
+3K141147Range Spinal SystemK2m, Inc.20141—
+3K140529Everest Spinal SystemK2m, LLC201431—
+3K140238Excella Iii-D Spinal Deformity SystemInnovasis, Inc.201432
+3K140010Fortress Pedicle Screw SystemSpineology, Inc.201411—
+3K133743Baxano Surgical Mis Spinal SystemBaxano Surgical, Inc.20140—
+3K140276CD Horizon Spinal SystemMedtronic Sofamor Danek201485—
+3K133746Polaris Spinal SystemBiomet Spine (Aka Ebi, LLC)2014671
+3K133287Presson Spinal Fixation SystemNexus Spine, LLC20141—
+3K133564Modification to Nautilus Spinal SystemLife Spine, LLC201413—
+3K132639CD Horizon Spinal SystemMedtronic Sofamor Danek USA, Inc.2013243—
+3K132866Nautilus Spinal SystemLife Spine, Inc.201315—
+3K131321CD Horizon Spinal SystemMedtronic Sofamor Danek USA2013195—
+3K124058Creo Stabilization SystemGlobus Medical, Inc.2013172—
+3K122877Range Spinal System, Small StatureK2m, Inc.201334—
+3K130646CD Horizon Spinal SystemMedtronic Sofamor Danek USA, Inc.2013244—
+3K130286Streamline Mis Spinal Fixation SystemPioneer Surgical Technology, Inc.201371
+3K123549Polaris Spinal System - Ballista II Percutaneous Screw Placement SystemBiomet Spine (Aka Ebi, LLC)2013752
+3K123809CD Horizon Spinal SystemMedtronic Sofamor Danek USA, Inc.20136—
+3K123521Reliance Spinal Screw SystemReliance Medical Systems, LLC20135—
+3K123138Pass LP Spinal SystemMedicrea International2013132—
+3K121670Medyssey Cannulated Pedicle ScrewMedyssey Co, Ltd.201311—
+3K122592Instinct Java SystemZimmer Spine201301
+3K122332Towerlox Pedicle Screw SystemCaptiva Spine201214—
+3K122862CD Horizon Spinal SystemMedtronic Sofamor Danek USA, Inc.2012211—
+3K122226Revere Stabilization SystemGlobus Medical, Inc.2012225—
+3K121630Range Spinal SystemK2m, Inc.2012127—
+3K120838Synthes Matrix SystemSynthes Spine201216—
+3K121922Beacon Stabilization SystemGlobus Medical, Inc.20129—
+3K121115M.U.S.T Pedicle Screw SystemMedacta International2012431
+3K120564Calypso SystemHogan Lovells US LLP201216—
+3K121342Xia 4.5 Spinal SystemStryker Corp.201288—
+3K113395Revere 4.5 Stabilization SystemGlobus Medical, Inc.2012260—
+3K120928Synthes Matrix SystemSynthes Spine20120—
+3K111449Revolve Additional ImplantsGlobus Medical, Inc.2011236—
+3K111479Revere CrosstopGlobus Medical, Inc.2011232—
+3K110963Ellipse Occipito-Cervico-Thoracic Spinal SystemGlobus Medical, Inc.201198—
+3K102488Apex Spine System W/ Cocr RodsSpinecraft, LLC2010177—
+3K080767Conquest Spinal SystemLife Spine200821—
+4K263172SAS MIS Pelvic Incidence RodsSpinal Alignment Solutions, Inc.20260—
+4K253802KHEIRON® Spinal Fixation System, including patient specific K-RODS.M.A.I.O20261—
+4K260989Varion Thoracolumbar Fixation SystemKyocera Medical Technologies Inc. (KMTI)20260—
+4K253739SCRIPT™ Rods, CREO™ Stabilization System, REVERE® Stabilization System, REVERE® 4.5…Globus Medical, Inc.20260—
+4K252542LEO Spinal SystemZheJiang Decans Medical Devices Co., Ltd.20260—
+4K260011Foundation Surgical Navigated Lateral Disc Prep InstrumentsFoundation Surgical Group, Inc.20260—
+4K254158SPINEART Navigation Instrument SystemSpineart SA20261—
+4K252087Navigation Module of the Cortium® SystemUlrich Medical USA, Inc.20260—
+4K254165Infinity™ OCT SystemMedtronic Sofamor Danek USA, Inc.20260—
+4K252962DYNAMIS™ Navigation SystemPromethean Restorative, LLC20260—
+4K250520OsteoCentric Navigated Instruments SystemOsteocentric Technologies, Inc.20250—
+4K252322SIros-X SystemGenesys Spine20250—
+4K253331PressON Spinal Fixation SystemNexus Spine20250—
+4K242933SPINEART Navigation Instrument SystemSpineart SA20252—
+4K243419Altus Spine Navigation SystemAltus Partners, LLC20250—
+4K250182Innovasis Navigation InstrumentsInnovasis, Inc.202521
+4K243259MASADA Modular Spinal Fixation SystemAstura Medical20250—
+4K242297Reform Pedicle Screw SystemPrecision Spine, Inc.20240—
+4K243281LOCK-IN Spinal Fixation SystemLock-In USA Corp20240—
+4K230325GREENS BRAND Posterior, Non-cervical Pedicle Screw Spinal SystemGreens Surgicals Pvt., Ltd.20240—
+4K241644SPINEART Navigation Instrument SystemSpineart SA20243—
+4K241892Cortera™ Spinal Fixation SystemXtant Medical Holdings, Inc.20242—
+4K241519Invictus® Small Stature Spinal Fixation SystemAlphatec Spine, Inc.20242—
+4K241082INNOVERSE Navigation InstrumentsInnosys Co., Ltd.20240—
+4K241034Meta+ Bone Cement & M.U.S.T. Fenestrated Pedicle Screw SystemMedacta International S.A.20242—
+4K241276Vector™ Pedicle Screw SystemInnovasis, Inc.202411
+4K240846CarboClear® Hybrid Pedicle Screw System; CarboClear® Hybrid Navigated Instruments…CarboFix Orthopedics, Ltd.20242—
+4K234048M.U.S.T. Pedicle Screw System - ExtensionMedacta International S.A.20241—
+4K233508iFuse Bedrock Granite® Implant SystemSI-BONE, Inc.20245—
+4K233455ARx MIS Spinal Screw SystemLife Spine, Inc.20230—
+4K231443Mini-OSTEO Pedicle Fixation SystemOsteomed Indústria E Comércio DE Implantes Ltda20230—
+4K231694MASADA Modular Spinal Fixation SystemAstura Medical20232—
+4K231744VyLink™ Spinal Screw SystemVy Spine, LLC20230—
+4K230961Zeus Spinal SystemShanghai Sanyou Medical Co, Ltd.20232—
+4K232218Zenius™ Spinal SystemMedyssey USA, Inc.20230—
+4K231931Adena-Zina Spinal SystemShanghai Sanyou Medical Co, Ltd.20230—
+4K223301ASTRA & AVANT Navigation Instruments System and ASTRA-OCT Navigation Instruments SystemSpinecraft, LLC20230—
+4K223808Zavation Navigation Instrument SystemZavation Medical Products, LLC20230—
+4K230774PERLA® TL System; TEKTONA® HV US Bone CementSpineart20230—
+4K230880CoreLink Navigation InstrumentsCorelink, LLC20230—
+4K230482Swedge™ Pedicle Screw Fixation SystemSpinal Resources, Inc.20231—
+4K222105RESPONSE 5.5/6.0 Cannulated Screw SystemOrthoPediatrics Corp.20230—
+4K223181NuVasive Reline SystemNu Vasive, Incorporated202311—
+4K223649VERTICALE® Navigation InstrumentsSilony Medical GmbH20223—
+4K222516Mercury® II Spinal SystemSpinal Elements, Inc.20223—
+4K222415Rexious Spinal Fixation SystemDio Medical Corporation20221—
+4K221905INERTIA CONNEXX Modular Pedicle Screw SystemNexxt Spine, LLC20221—
+4K220973CoreLink Navigation InstrumentsCorelink, LLC20221—
+4K220285PINE Pedicle Screw SystemTdm Co., Ltd.20220—
+4K213491Universal Pilot Guidance Instrument SystemCtl Medical Corporation20220—
+4K220341ARx Modular Spinal SystemLife Spine, Inc.20221—
+4K220038Camber Spine Navigation SystemCamber Spine Technologies20220—
+4K213470PERLA® TL Posterior Osteosynthesis SystemSpineart20222—
+4K212489BonOs Inject Bone Cement; NEO Pedicle Screw SystemNeo Medical SA20215—