510(k) Report

Devices descending from K050282

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

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+5K152968Arsenal Spinal Fixation SystemAlphatec Spine, Inc.201583—
+5K152632XIA 4.5 Spinal Fixation System, Power Adaaptor Instrument AccessoryStryker Corporation201531—
+5K151974Polaris Spinal SystemBiomet Spine201516—
+5K151727Everest Spinal SystemK2m, Inc.201511—
+5K152148Fortress Pedicular Fixation SystemSpineology, Inc.20158—
+5K150896Vitality Spinal Fixation SystemZimmer Spine, Inc.2015193
+5K151422Reform Pedicle Screw SystemPrecision Spine, Inc.201519—
+5K151216Everest Spinal SystemK2m, Inc.201511—
+5K150552ELLIPSE and PROTEX CT OCCIPITO-CERVICO-THORACIC SPINAL SYSTEMSGlobus Medical, Inc.2015961
+5K143683APEX-DL Spine SystemSpinecraft, LLC20153—
+5K150417Astra Spine SystemSpinecraft, LLC201521—
+5K143731IMPLANET Spine System (ISS)Implanet, S.A.20158—
+5K150647Polyscrew Pedicle Screw SystemNew Era Orthopedics, LLC201501
+5K150325Range/Denali/Mesa Spinal SystemK2m, Inc.201512—
+5K142798PASS LP Spinal SystemMedicrea International SA201584—
+5K142531F1-Modular Pedicle Screw SystemDegen Medical20152—
+5K150390Nautilus Spinal SystemLife Spine, Inc.20150—
+5K150049PASS LP Spinal SystemMedicrea International20150—
+5K143633CREO Stabilization SystemGlobus Medical, Inc.2015158—
+5K141398Pass LP Spinal SystemMedicrea International SA2015101
+5K143334Range/Denali/Mesa Spinal SystemK2m, Inc.201516—
+5K143248Reform Pedicle Screw SystemPrecision Spine, Inc.201430—
+5K143403Threshold Pedicular Fixation SystemSpineology, Inc.20148—
+5K140738Pass LP Spinal SystemMedicrea International201447—
+5K141850Flospine Pedicle Screw SystemFlospine20140—
+5K142381Xia 3 Spinal SystemStryker Corp.201483—
+5K141804Polaris Spinal System - HA CoatedBiomet Spine, LLC201421—
+5K141873Range/Mesa/Denali Spinal SystemK2m, Inc.201430—
+5K141988M.U.S.T Pedicle Screw SystemMedacta International201426—
+5K141044M.U.S.T. ExtensionMedacta International201416—
+5K133402K2M Modular HooksK2m, Inc.20140—
+5K141605CD Horizon Spinal SystemMedtronic Sofamor Danek USA, Inc.2014210—
+5K140765Range/Mesa/Denali Spinal SystemK2m, Inc.201415—
+5K132788Myspine Pedicle Screw Placement GuidesMedacta International201412—
+5K140123Polaris Spinal System -Translation ScrewEbi, LLC2014221
+5K133366Orthros Posterior Stabilization SystemCamber Spine20142—
+5K140457Nautilus Spinal SystemLife Spine, Inc.20143—
+5K133944Range, Spinal System, Everest Spinal SystemK2m, Inc.201433—
+5K133221Arsenal Spinal Fixation SystemAlphatec Spine, Inc.20141502
+5K133350Revere Stabilization SystemGlobus Medical, Inc.201493—
+5K132403Annextm Adjacent Level SystemSpine Wave, Inc.20142—
+5K132878M.U.S.T. ExtensionMedacta International201328—
+5K133188Mantis & Mantis Redux Spinal System, Radius Spinal System, Trio & Trio+ Spinal Fixation…Stryker Spine201384—
+5K132603Apex Spine SystemSpinecraft, LLC201325—
+5K132757Everest Spinal SystemK2m, Inc.201341—
+5K132574Pass LP Spinal SystemMedicrea International20130—
+5K132303Implanet Spine SystemImplanet, S.A.201315—
+5K132575Pass LP Spinal SystemMedicrea International20130—
+5K132760Nautilus Spinal SystemLife Spine, Inc.201314—
+5K132644Lospa IS Pedicle Screw (Monoaxial & Polyaxial), Lospa IS Rod- Straight (Standard), Lospa…Corentec Co., Ltd.20130—
+5K131615Polaris Spinal SystemBiomet Spine (Aka Ebi, LLC)201370—
+5K131784Range Spinal SystemK2m, Inc.201334—
+5K131878Lliad, Kora, Zenius Pedicle Screw SystemMedyssey USA, Inc.20138—
+5K131538Caplox II Pedicle Screw System/Towerlox Pedicle Screw SystemCaptiva Spine20136—
+5K130932Firebird Spinal Fixation SystemOrthofix, Inc.2013811
+5K131100Streamline TL Spinal SystemPioneer Surgical Technology, Inc.20136—
+5K130330Range Spinal SystemK2m, Inc.201336—
+5K123783Ellipse Occipito-Cerico-Thoracic Spinal System and Capitol ImplantsGlobus Medical, Inc.201397—
+5K123412Range Spinal System, Small Strature ComponentsK2m, Inc.201334—
+5K121568Dali Spinal Fixation SystemAccel Spine20121—
+5K112607Spinevision Lumis (TM) Cannulated Polyaxial Pedicle Screw Fixation System, Spinevision…Spinevision S.A.20125—
+5K120270Venus Spinal Fixation SystemL&K BIOMED Co., Ltd.2012111—
+5K110906Apex Spine SystemSpinecraft, LLC2011103—
+6K262067iFuse Granite Onyx™ Implant SystemSI-BONE, Inc.20260—
+6K262828KHEIRON® Spinal Fixation System, including patient specific K-RODS.M.A.I.O20260—
+6K261205SPINEART Navigation Instrument SystemSpineart SA20260—
+6K253943Tiger 2 SystemZavation Medical Products, LLC20260—
+6K260362QUATTRO Spinal system (Open Configuration); QUATTRO-GADGET Spinal system (MIS…MANTIZ Co., Ltd.20260—
+6K261284Invictus® Small Stature Spinal Fixation System; Invictus® 2.0 Spinal Fixation SystemAlphatec Spine, Inc.20260—
+6K253921VERTICALE® Navigation InstrumentsSilony Medical GmbH20260—
+6K260286Dynamo™ Spinal Cement; Salvo® Spine SystemSpine Wave, Inc.20260—
+6K260571SIMPACT Sacroiliac Joint Fixation System GX Navigation InstrumentsLife Spine, Inc.20260—
+6K261374LigaPASS™ SystemMedicrea International S.A.S20260—
+6K253966PERLA® TL Posterior Thoraco-lumbar Fixation SystemSpineart SA20260—
+6K253940M.U.S.T. Pedicle Screw System - ExtensionMedacta International S.A.20260—
+6K254274ARx® SAI Implant SystemLife Spine, Inc.20260—
+6K253615Invictus Bands SystemAlphatec Spine, Inc.20260—
+6K254045CarboClear® Posterior Cervical Screw System; CarboClear® Hybrid Posterior Cervical Screw…CarboFix Orthopedics, Ltd.20260—
+6K253169Duet™ Spinal Fixation SystemBox Spine, LLC20261—
+6K254148VERTICALE GPS InstrumentsSilony Medical GmbH20260—
+6K253545Vulcan Spinal SystemK2m, Inc.20260—
+6K252885OLYMPIC Posterior Spinal Fixation System; MASADA Modular Spinal Fixation SystemAstura Medical20260—
+6K252461Swedge™ Pedicle Screw Fixation System Bezier RodSpinal Resources, Inc.20260—
+6K253129Infinity™ OCT SystemMedtronic Sofamor Danek USA, Inc.20250—
+6K252346OLYMPIC Posterior Spinal Fixation System; MASADA Modular Spinal Fixation SystemAstura Medical20250—
+6K253094iFuse Bedrock Granite Implant SystemSI-BONE, Inc.20250—
+6K251780iGPS Navigation InstrumentsSI-BONE, Inc.20250—
+6K252437JAZZ Spinal SystemImplanet20250—
+6K250167Evolution Spine Navigation InstrumentsEvolution Spine20250—
+6K251073Innovasis Navigation Instruments (Vector G-E Navigation Instruments and the Excella G-E…Innovasis, Inc.202501
+6K241525ExcelsiusXR™Globus Medical, Inc.20250—
+6K251131Annex® 2 Adjacent Level SystemSpine Wave, Inc.20250—
+6K243326Dynamis Robotic Surgical SystemLEM Surgical AG20251—
+6K243514Salvo® Robotic Navigation InstrumentsSpine Wave, Inc.20250—
+6K242890SPINEART Navigation Instrument SystemSpineart SA20253—
+6K243916Primus Spinal Fixation SystemSpinal Elements, Inc.20252—
+6K243946EffortMed Spinal Fixation SystemEffortmed, LLC20251—
+6K243814NuVasive Pulse SystemGlobus Medical, Inc.20250—
+6K243671ExcelsiusGPS® InstrumentsGlobus Medical, Inc.20240—
+6K242764MediRod Pedicle Screw SystemCmf Medicon Surgical, Inc.20240—