510(k) Report

Devices descending from K040442

551 later devices reach Protex Stabilization System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K073517H-Link Integrated RodGlobus Medical, Inc.20080—
+1K061202Revere Stabilization SystemGlobus Medical, Inc.2006547—
+1K052069Protex Stabilization System with Additional ComponentesGlobus Medical, Inc.2005549—
+1K042953Modification to Protex Stabilization SystemGlobus Medical, Inc.20040—
+2K253739SCRIPT™ Rods, CREO™ Stabilization System, REVERE® Stabilization System, REVERE® 4.5…Globus Medical, Inc.20260—
+2K220285PINE Pedicle Screw SystemTdm Co., Ltd.20220—
+2K213820BALTEUM - ONE™ Lumbar Plate SystemHuvexel Co., Ltd.20223—
+2K210420Goblin and Goblin LS Pedicle Screw SystemsMedynus, Inc.20211—
+2K181068CREO® Stabilization System, REVERE® Stabilization SystemGlobus Medical, Inc.20182—
+2K180210CREO® Stabilization SystemGlobus Medical, Inc.201888—
+2K160775Thunderbolt™ Minimally Invasive and Lancer™ Open Pedicle Screw SystemsChoicespine, LP201673—
+2K133366Orthros Posterior Stabilization SystemCamber Spine20142—
+2K133350Revere Stabilization SystemGlobus Medical, Inc.201493—
+2K123783Ellipse Occipito-Cerico-Thoracic Spinal System and Capitol ImplantsGlobus Medical, Inc.201397—
+2K121670Medyssey Cannulated Pedicle ScrewMedyssey Co, Ltd.201311—
+2K122226Revere Stabilization SystemGlobus Medical, Inc.2012225—
+2K121922Beacon Stabilization SystemGlobus Medical, Inc.20129—
+2K113395Revere 4.5 Stabilization SystemGlobus Medical, Inc.2012260—
+2K111449Revolve Additional ImplantsGlobus Medical, Inc.2011236—
+2K111479Revere CrosstopGlobus Medical, Inc.2011232—
+2K110280Revlok Fenestrated Screw SystemGlobus Medical, Inc.201195—
+2K103072Revere Sacral PlatesGlobus Medical, Inc.2011233—
+2K100788Cocr RodsGlobus Medical, Inc.2010374—
+2K093294Revere Stabilization SystemGlobus Medical, Inc.2010376—
+2K091782Revere 6.35 Stabilization SystemGlobus Medical, Inc.2009404—
+2K092108Truss Thoracolumbar Plate SystemGlobus Medical, Inc.200942—
+2K073439Transition Stabilization SystemGlobus Medical, Inc.20092—
+2K083416Revolve Stabilization SystemGlobus Medical, Inc.2009297—
+2K081195Revere Uniplanar ScrewsGlobus Medical, Inc.2008405—
+2K073143Modified Vertiflex Spinal Screw SystemVertiflex, Inc.20080—
+2K073430Valeo Pedicle Screw Spinal SystemAmedica Corp.200824—
+2K073172Beacon Stabilization SystemGlobus Medical, Inc.2007376—
+2K062836Citadel Anterior Lumbar Plate SystemGlobus Medical, Inc.200650—
+2K062407Gateway Thoracolumbar Plate SystemGlobus Medical, Inc.2006127—
+3K260362QUATTRO Spinal system (Open Configuration); QUATTRO-GADGET Spinal system (MIS…MANTIZ Co., Ltd.20260—
+3K241519Invictus® Small Stature Spinal Fixation SystemAlphatec Spine, Inc.20242—
+3K231443Mini-OSTEO Pedicle Fixation SystemOsteomed Indústria E Comércio DE Implantes Ltda20230—
+3K232318VICTORY™ Lumbar Plate SystemGlobus Medical, Inc.20230—
+3K232586Rexious Spinal Fixation System, Statera™ Spinal System, Statera-M™ Spinal SystemK&J Consulting Corp.20230—
+3K232341CarboClear® Pedicle Screw SystemCarboFix Orthopedics, Ltd.20234—
+3K232218Zenius™ Spinal SystemMedyssey USA, Inc.20230—
+3K230721ATEC Lateral Plate SystemAlphatec Spine, Inc.20230—
+3K223273ASTRA Spine SystemSpinecraft, LLC20228—
+3K213196MARVEL™ Growing RodsGlobus Medical, Inc.20220—
+3K222572FORTIS and HANA Anterior Cervical Plate System, Rex Anterior Cervical Plate System, and…Dio Medical Corporation20222—
+3K200937ACURA Stabilization SystemIndius Medical Technologies Pvt., Ltd.20200—
+3K200981Mega Plus MIS Spine SystemBk Meditech, Co., Ltd.20200—
+3K192938Invictus™ Spinal Fixation SystemAlphatec Spine, Inc.201969—
+3K182478Whistler Modular Pedicle Screw SystemEvolution Spine, LLC20196—
+3K182954Salvo™ Spine SystemSpine Wave, Inc.20186—
+3K181846ASSURE Anterior Cervical Plate System, PROVIDENCE Anterior Cervical Plate System, VIP…Globus Medical, Inc.20184—
+3K180980ORTHROS™ Posterior Stabilization System; ORTHROS™ MIS Posterior Stabilization SystemCamber Spine Technologies, LLC20181—
+3K181677Kodiak Spinal Fixation SystemAlphatec Spine, Inc.201870—
+3K181139OLYMPIC Posterior Spinal Fixation SystemAstura Medical, LLC20188—
+3K172269FORTRESS™ Radiopaque Bone Cement (FORTRESS™ and FORTRESS-Plus™), CREO® Fenestrated Screw…Globus Medical, Inc.20184—
+3K173508Everest Spinal SystemK2m20189—
+3K173131Rexious Spinal Fixation SystemHuvexel Co., Ltd.20175—
+3K171526Zenius™, lliad™ and Kora™ Spinal Fixation SystemsMedyssey USA, Inc.20172—
+3K171651Excelsius GPSGlobus Medical, Inc.2017691
+3K171456Thunderbolt™ Minimally Invasive and Lancer™ Open Pedicle Screw SystemsChoicespine20170—
+3K170942The Thunderbolt™ Minimally Invasive and Lancer™ Open Pedicle Screw SystemsChoicespine, LP20170—
+3K162160Preference Elite Pedicle Screw SystemAmedica Corporation20161—
+3K160989NuVasive® Reline® SystemNu Vasive, Incorporated201667—
+3K151704Diplomat® Spinal SystemSignus Medizintechnik GmbH20164—
+3K152148Fortress Pedicular Fixation SystemSpineology, Inc.20158—
+3K150552ELLIPSE and PROTEX CT OCCIPITO-CERVICO-THORACIC SPINAL SYSTEMSGlobus Medical, Inc.2015961
+3K141222Nautilus Spinal System and Solstice Oct SystemLife Spine, Inc.201513—
+3K142699LITe Plate SystemStryker Corporation201446—
+3K141804Polaris Spinal System - HA CoatedBiomet Spine, LLC201421—
+3K133153Spinefrontier Pedfuse Pedicle Screw SystemSpinefrontier, Inc.20141—
+3K140238Excella Iii-D Spinal Deformity SystemInnovasis, Inc.201432
+3K132403Annextm Adjacent Level SystemSpine Wave, Inc.20142—
+3K132603Apex Spine SystemSpinecraft, LLC201325—
+3K132361Everest Spinal SystemK2m, Inc.201334—
+3K131615Polaris Spinal SystemBiomet Spine (Aka Ebi, LLC)201370—
+3K131878Lliad, Kora, Zenius Pedicle Screw SystemMedyssey USA, Inc.20138—
+3K124058Creo Stabilization SystemGlobus Medical, Inc.2013172—
+3K123717UcentumUlrich GmbH & Co. KG2013171
+3K112607Spinevision Lumis (TM) Cannulated Polyaxial Pedicle Screw Fixation System, Spinevision…Spinevision S.A.20125—
+3K120092Plymouth Thoracolumbar Plate SystemGlobus Medical, Inc.201241—
+3K103671Genesys Spine Tilock SystemGenesys Spine20118—
+3K110963Ellipse Occipito-Cervico-Thoracic Spinal SystemGlobus Medical, Inc.201198—
+3K102488Apex Spine System W/ Cocr RodsSpinecraft, LLC2010177—
+3K100061Cayman Screws Model K2-12-1000-XX, K2-12-1001-XXK2m, Inc.201073—
+3K092610Modification to Beacon Stabilization SystemGlobus Medical, Inc.2009375—
+3K080767Conquest Spinal SystemLife Spine200821—
+4K262067iFuse Granite Onyx™ Implant SystemSI-BONE, Inc.20260—
+4K253943Tiger 2 SystemZavation Medical Products, LLC20260—
+4K261284Invictus® Small Stature Spinal Fixation System; Invictus® 2.0 Spinal Fixation SystemAlphatec Spine, Inc.20260—
+4K253615Invictus Bands SystemAlphatec Spine, Inc.20260—
+4K254148VERTICALE GPS InstrumentsSilony Medical GmbH20260—
+4K251780iGPS Navigation InstrumentsSI-BONE, Inc.20250—
+4K251073Innovasis Navigation Instruments (Vector G-E Navigation Instruments and the Excella G-E…Innovasis, Inc.202501
+4K241525ExcelsiusXR™Globus Medical, Inc.20250—
+4K251719Momentum® Posterior Spinal Fixation SystemUlrich Medical USA, Inc.20250—
+4K251131Annex® 2 Adjacent Level SystemSpine Wave, Inc.20250—
+4K250446Frida™ Anterior Cervical Plate SystemSpineup, Inc.20250—
+4K243326Dynamis Robotic Surgical SystemLEM Surgical AG20251—
+4K243514Salvo® Robotic Navigation InstrumentsSpine Wave, Inc.20250—
+4K243814NuVasive Pulse SystemGlobus Medical, Inc.20250—