510(k) Report

Devices descending from K022778

670 later devices reach Modification to TSRH Spinal System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K103049TSRH Spinal SystemMedtronic Sofamor Danek2010244—
+1K090740Modification to: TSRH Spinal SystemMedtronic Sofamor Danek20091—
+1K072429Modification to TSRH Spinal SystemMedtronic Sofamor Danek200710—
+1K072317Modification to:TSRH Spinal SystemMedtronic Sofamor Danek USA, Inc.20076254
+1K033352Vertebron PSS Pedicle Screw SystemVertebron, Inc.200462—
+2K211027Altus Spine Pedicle Screw SystemAltus Partners, LLC20222—
+2K181995Chiral Surgical Pedicle Screw SystemChiral Surgical20180—
+2K151648Altus Spine Pedicle Screw System, Altus Spine MIS Pedicle Screw System, Valencia Pedicle…Altus Partners, LLC20155—
+2K132280Altus Spine Pedicle Screw SystemAltus Partners20136—
+2K131810Osseus Black Diamond Pedicle Screw SystemOsseus Fusion Systems, LLC201314—
+2K110896Reliance Spinal Screw SystemReliance Medical Systems, LLC20125—
+2K111942TSRH Spinal SystemsMedtronic Sofamor Danek USA, Inc.2011242—
+2K101112Reliance Spinal Screw SystemReliance Medical Systems20107—
+2K092676TSRH Spinal SystemMedtronic Sofamor Danek, Inc.20090—
+2K081978Reliance Spinal Screw SystemReliance Medical Systems, LLC20098—
+2K081080TSRH Spinal SystemMedtronic Sofamor Danek2008614—
+2K081597Modification to Vertebron PSS Pedicle Screw SystemVertebron, Inc.200822—
+2K073531Accin Pedicle Screw SystemAccelerated Innovation, LLC20080—
+2K073430Valeo Pedicle Screw Spinal SystemAmedica Corp.200824—
+2K071376Modification to Vertebron PSS Pedicle Screw SystemVertebron, Inc.200749—
+2K051716Vertebron PSS Pedicle Screw SystemVertebron, Inc.200556—
+2K043152Vertebron PSS Pedicle Screw SystemVertebron, Inc.200561—
+3K230766Altus Spine Monaco Pedicle Screw SystemAltus Spine20231—
+3K221332OsteoCentric Spine MIS Pedicle Fastener SystemOsteoCentric Technologies20221—
+3K213750VyLink™ Spinal Screw SystemVy Spine, LLC20221—
+3K200981Mega Plus MIS Spine SystemBk Meditech, Co., Ltd.20200—
+3K192121Black Diamond Pedicle Screw SystemOsseus Fusion Systems201913—
+3K190567KeYi Spinal Fixation SystemBeijing Keyi Medical Device Technology Co., Ltd.20190—
+3K181339Altus Spine Pedicle Screw SystemAltus Partners, LLC20186—
+3K181281Altus Spine Pedicle Screw SystemAltus Partners, LLC20181—
+3K162066Reliance Spinal Screw SystemReliance Medical Systems, LLC20163—
+3K162160Preference Elite Pedicle Screw SystemAmedica Corporation20161—
+3K151704Diplomat® Spinal SystemSignus Medizintechnik GmbH20164—
+3K152131Reliance Spinal Screw SystemReliance Medical Systems, LLC20154—
+3K143230Palladian Lumbar Pedicle Screw SystemNeurostructures, Inc.20150—
+3K141282PGS 5.5 MM Cannulated Pedicle ScrewPinnacle Spine Group20141—
+3K133287Presson Spinal Fixation SystemNexus Spine, LLC20141—
+3K122877Range Spinal System, Small StatureK2m, Inc.201334—
+3K123521Reliance Spinal Screw SystemReliance Medical Systems, LLC20135—
+3K123138Pass LP Spinal SystemMedicrea International2013132—
+3K121630Range Spinal SystemK2m, Inc.2012127—
+3K120353Synster Pedicle Screw System Synster Plus Pedicle Screw SystemBm Korea Co., Ltd.20123—
+3K091797TSRH Spinal SystemMedtronic Sofamor Danek2010606—
+3K080767Conquest Spinal SystemLife Spine200821—
+4K250520OsteoCentric Navigated Instruments SystemOsteocentric Technologies, Inc.20250—
+4K243419Altus Spine Navigation SystemAltus Partners, LLC20250—
+4K243281LOCK-IN Spinal Fixation SystemLock-In USA Corp20240—
+4K231744VyLink™ Spinal Screw SystemVy Spine, LLC20230—
+4K213935PISCES-SA Standalone ALIF Interbody SystemOsseus Fusion Systems202212—
+4K220341ARx Modular Spinal SystemLife Spine, Inc.20221—
+4K212185Golden Isles Pedicle Screw SystemIntelivation, LLC20210—
+4K210874Reliance Spinal Screw SystemReliance Medical Systems, LLC20212—
+4K203452Nano FortiFix® SystemNanovis, LLC20200—
+4K200322Altus Spine Pedicle Screw SystemAltus Partners, LLC20204—
+4K191655MEGAFIX® Pedicle Screw Spinal SystemSeohancare Co., Ltd.20200—
+4K191932Momentum™ Posterior Spinal Fixation SystemUlrich Medical USA20192—
+4K171832Range/Denali/Mesa Spinal SystemK2m, Inc.201713—
+4K161028K2M Growing Spine SystemK2m, Inc.20163—
+4K160820PressON Pro Spinal Fixation SystemNexus Spine, LLC20160—
+4K143110GALAXY MIS Screw SystemBm Korea20152—
+4K150325Range/Denali/Mesa Spinal SystemK2m, Inc.201512—
+4K142798PASS LP Spinal SystemMedicrea International SA201584—
+4K141222Nautilus Spinal System and Solstice Oct SystemLife Spine, Inc.201513—
+4K150049PASS LP Spinal SystemMedicrea International20150—
+4K141398Pass LP Spinal SystemMedicrea International SA2015101
+4K140738Pass LP Spinal SystemMedicrea International201447—
+4K141873Range/Mesa/Denali Spinal SystemK2m, Inc.201430—
+4K140765Range/Mesa/Denali Spinal SystemK2m, Inc.201415—
+4K141147Range Spinal SystemK2m, Inc.20141—
+4K133153Spinefrontier Pedfuse Pedicle Screw SystemSpinefrontier, Inc.20141—
+4K133944Range, Spinal System, Everest Spinal SystemK2m, Inc.201433—
+4K132757Everest Spinal SystemK2m, Inc.201341—
+4K132574Pass LP Spinal SystemMedicrea International20130—
+4K132575Pass LP Spinal SystemMedicrea International20130—
+4K131784Range Spinal SystemK2m, Inc.201334—
+4K130932Firebird Spinal Fixation SystemOrthofix, Inc.2013811
+4K130330Range Spinal SystemK2m, Inc.201336—
+4K123373Nautilus Spinal SystemLife Spine201317—
+4K123412Range Spinal System, Small Strature ComponentsK2m, Inc.201334—
+4K111953Nautilus Spinal SystemLife Spine20123—
+4K112555CD Horizon (R) Spinal SystemMedtronic Sofamor Danek USA, Inc.2011597—
+4K101790Quantum Spinal System, Quantum MisPioneer Surgical Technology201110—
+4K090320Conquest Spinal SystemLife Spine20092—
+5K253802KHEIRON® Spinal Fixation System, including patient specific K-RODS.M.A.I.O20261—
+5K253739SCRIPT™ Rods, CREO™ Stabilization System, REVERE® Stabilization System, REVERE® 4.5…Globus Medical, Inc.20260—
+5K253545Vulcan Spinal SystemK2m, Inc.20260—
+5K251719Momentum® Posterior Spinal Fixation SystemUlrich Medical USA, Inc.20250—
+5K250845Curiteva Porous PEEK Standalone ALIF SystemCuriteva, Inc.20251—
+5K242361OZARK Cervical Plate System; PYRENEES® Cervical Plate System; EVEREST® Spinal System…Stryker Spine20241—
+5K240180Orthopeasia Spinal Fixation SystemOrthopeasia Co., Ltd.20240—
+5K240326Solar™ Lumbar Interbody Fusion SystemDegen Medical, Inc.20244—
+5K233455ARx MIS Spinal Screw SystemLife Spine, Inc.20230—
+5K231809Momentum® Posterior Spinal Fixation System with G21 V-STEADY Bone Cement; Momentum® MIS…Ulrich Medical USA20231—
+5K232275Invictus® Spinal Fixation SystemAlphatec Spine, Inc.202311—
+5K231199Solar Lumbar Interbody Fusion SystemDegen Medical20235—
+5K223413Pisces™-SA STANDALONE ALIF Interbody SystemOsseus Fusion Systems20233—
+5K201788EDEN Spinal Fixation SystemJmt Co., Ltd.20221—
+5K211981KHEIRON® Spinal Fixation SystemS.M.A.I.O20228—
+5K220724CD Horizon™ Spinal System and PASS LP™ Spinal SystemMedicrea International20221—
+5K220025ARx® Spinal SystemLife Spine, Inc.20220—