510(k) Report

Devices descending from K122226

225 later devices reach Revere Stabilization System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K231443Mini-OSTEO Pedicle Fixation SystemOsteomed Indústria E Comércio DE Implantes Ltda20230—
+1K180210CREO® Stabilization SystemGlobus Medical, Inc.201888—
+1K173508Everest Spinal SystemK2m20189—
+1K141804Polaris Spinal System - HA CoatedBiomet Spine, LLC201421—
+1K133350Revere Stabilization SystemGlobus Medical, Inc.201493—
+1K132403Annextm Adjacent Level SystemSpine Wave, Inc.20142—
+1K124058Creo Stabilization SystemGlobus Medical, Inc.2013172—
+1K123783Ellipse Occipito-Cerico-Thoracic Spinal System and Capitol ImplantsGlobus Medical, Inc.201397—
+2K253739SCRIPT™ Rods, CREO™ Stabilization System, REVERE® Stabilization System, REVERE® 4.5…Globus Medical, Inc.20260—
+2K251131Annex® 2 Adjacent Level SystemSpine Wave, Inc.20250—
+2K243259MASADA Modular Spinal Fixation SystemAstura Medical20250—
+2K243281LOCK-IN Spinal Fixation SystemLock-In USA Corp20240—
+2K242361OZARK Cervical Plate System; PYRENEES® Cervical Plate System; EVEREST® Spinal System…Stryker Spine20241—
+2K232719ProMIS Extension Rod SystemPremia Spine, Ltd.20230—
+2K231694MASADA Modular Spinal Fixation SystemAstura Medical20232—
+2K232586Rexious Spinal Fixation System, Statera™ Spinal System, Statera-M™ Spinal SystemK&J Consulting Corp.20230—
+2K232341CarboClear® Pedicle Screw SystemCarboFix Orthopedics, Ltd.20234—
+2K212066Adena-Zina SystemShanghai Sanyou Medical Co, Ltd.20213—
+2K210275Polaris Spinal SystemZimmer Biomet Spine, Inc.20210—
+2K203153CREO Stabilization System, Navigation Instruments, ExcelsiusGPSGlobus Medical, Inc.20211—
+2K200937ACURA Stabilization SystemIndius Medical Technologies Pvt., Ltd.20200—
+2K192938Invictus™ Spinal Fixation SystemAlphatec Spine, Inc.201969—
+2K191835CREO Stabilization System, Navigation Instruments, ExcelsiusGPS InstrumentsGlobus Medical, Inc.20192—
+2K190376PASS LP Spinal SystemMedicrea International SA201915
+2K182478Whistler Modular Pedicle Screw SystemEvolution Spine, LLC20196—
+2K182954Salvo™ Spine SystemSpine Wave, Inc.20186—
+2K181139OLYMPIC Posterior Spinal Fixation SystemAstura Medical, LLC20188—
+2K181068CREO® Stabilization System, REVERE® Stabilization SystemGlobus Medical, Inc.20182—
+2K181119Range (Denali and Mesa) Spinal SystemsK2m, Inc.20185—
+2K180376K2M Patient Specific RodsK2m, Inc.20182—
+2K171651Excelsius GPSGlobus Medical, Inc.2017691
+2K151422Reform Pedicle Screw SystemPrecision Spine, Inc.201519—
+2K150552ELLIPSE and PROTEX CT OCCIPITO-CERVICO-THORACIC SPINAL SYSTEMSGlobus Medical, Inc.2015961
+2K150647Polyscrew Pedicle Screw SystemNew Era Orthopedics, LLC201501
+2K141222Nautilus Spinal System and Solstice Oct SystemLife Spine, Inc.201513—
+2K143633CREO Stabilization SystemGlobus Medical, Inc.2015158—
+2K141253New Era Orthopaedics Polyscrew Pedicle Screw SystemNew Era Orthopaedics, LLC201511
+2K133366Orthros Posterior Stabilization SystemCamber Spine20142—
+3K262067iFuse Granite Onyx™ Implant SystemSI-BONE, Inc.20260—
+3K254148VERTICALE GPS InstrumentsSilony Medical GmbH20260—
+3K253545Vulcan Spinal SystemK2m, Inc.20260—
+3K252346OLYMPIC Posterior Spinal Fixation System; MASADA Modular Spinal Fixation SystemAstura Medical20250—
+3K251780iGPS Navigation InstrumentsSI-BONE, Inc.20250—
+3K251073Innovasis Navigation Instruments (Vector G-E Navigation Instruments and the Excella G-E…Innovasis, Inc.202501
+3K241525ExcelsiusXR™Globus Medical, Inc.20250—
+3K243326Dynamis Robotic Surgical SystemLEM Surgical AG20251—
+3K243514Salvo® Robotic Navigation InstrumentsSpine Wave, Inc.20250—
+3K243814NuVasive Pulse SystemGlobus Medical, Inc.20250—
+3K243671ExcelsiusGPS® InstrumentsGlobus Medical, Inc.20240—
+3K242764MediRod Pedicle Screw SystemCmf Medicon Surgical, Inc.20240—
+3K240160EGPS Navigated InstrumentsAstura Medical20240—
+3K233793CarboClear® X Pedicle Screw SystemCarboFix Orthopedics, Ltd.20241—
+3K241519Invictus® Small Stature Spinal Fixation SystemAlphatec Spine, Inc.20242—
+3K240721ExcelsiusFlex™Globus Medical, Inc.20240—
+3K240951Invictus Robotic Navigation InstrumentsAlphatec Spine20242—
+3K240568DuraPro™ Oscillating SystemGlobus Medical, Inc.20240—
+3K231850QUARTEX® Occipito-Cervico-Thoracic Spinal System ExcelsiusGPS® InstrumentsGlobus Medical, Inc.20242—
+3K234048M.U.S.T. Pedicle Screw System - ExtensionMedacta International S.A.20241—
+3K233638VERZA™ High Speed DrillsGlobus Medical, Inc.20241—
+3K233944CarboClear® X Pedicle Screw System; CarboClear® X Navigated InstrumentsCarboFix Orthopedics, Ltd.20243—
+3K233332Statera-C™ Spinal SystemK&J Consulting Corp.20230—
+3K231494CoreLink Robotic Navigation InstrumentsCorelink, LLC20230—
+3K230961Zeus Spinal SystemShanghai Sanyou Medical Co, Ltd.20232—
+3K232044Invictus Robotic Navigation InstrumentsAlphatec Spine, Inc.20233—
+3K231636LnK Spinal Fixation System /OpenLoc-L Spinal Fixation System, AccelFix Spinal Fixation…L&K BIOMED Co., Ltd.20232—
+3K223558CUVIS-spineCurexo, Inc.20230—
+3K223350Remi Robotic Navigation SystemFusion Robotics, LLC20230—
+3K230245LnK Spinal Fixation System/OpenLoc-L Spinal Fixation System; AccelFix Spinal Fixation…L&K BIOMED Co., Ltd.20233—
+3K213196MARVEL™ Growing RodsGlobus Medical, Inc.20220—
+3K221403Cortera Spinal Fixation SystemSurgalign Spine Technologies202232
+3K220862E-GPS Navigated InstrumentsPrecision Spine, Inc.20227—
+3K220025ARx® Spinal SystemLife Spine, Inc.20220—
+3K213281PASS LP™ Spinal System, CD Horizon™ Spinal SystemMedicrea International SA20220—
+3K211616ExcelsiusHubGlobus Medical, Inc.20219Class I
+3K201569CUVIS-spineCurexo, Inc.20212—
+3K202184Practical Navigation Surgical Guidance System (PNSGS)Practical Navigation, LLC20215—
+3K200922Altus Spine HA Pedicle Screw SystemAltus Partners, LLC20213—
+3K203125Invictus™ OCT Spinal Fixation SystemAlphatec Spine, Inc.20200—
+3K203056Invictus™ Spinal Fixation SystemAlphatec Spine, Inc.202061—
+3K202327Invictus™ OsseoScrew® SystemAlphatec Spine, Inc.20200—
+3K200047ExcelsiusGPS Cranial 1.0 ModuleGlobus Medical, Inc.202053
+3K200936Invictus™ CT Spinal Fixation SystemAlphatec Spine, Inc.20203—
+3K200303Reform Pedicle Screw SystemPrecision Spine202010—
+3K193396PERLA® TL posterior osteosynthesis systemSpineart202072
+3K191100ExcelsiusGPS Spine 1.1 Interbody ModuleGlobus Medical, Inc.201942—
+3K191045Salvo™ Spine SystemSpine Wave, Inc.20195—
+3K183119SI-LOK® Sacroiliac Joint Fixation System, Navigation Instruments, ExcelsiusGPS®…Globus Medical, Inc.20192—
+3K182000AQrate Robotic Assistance SystemGlobus Medical, Inc.20191—
+3K182508Saxxony™ Posterior Cervical Thoracic SystemNexxt Spine, LLC20184—
+3K180980ORTHROS™ Posterior Stabilization System; ORTHROS™ MIS Posterior Stabilization SystemCamber Spine Technologies, LLC20181—
+3K181350ASTRA-OCT Spine SystemSpinecraft, LLC20180—
+3K161591QUARTEX™ Occipito-Cervico-Thoracic Spinal System, Globus Navigation InstrumentsGlobus Medical, Inc.201678—
+3K153370Caspian OCT/MESA Mini/DENALI Mini Spinal SystemK2m, Incorporated201617—
+3K151196Nautilus Spinal SystemLife Spine, Inc.201512—
+4K261284Invictus® Small Stature Spinal Fixation System; Invictus® 2.0 Spinal Fixation SystemAlphatec Spine, Inc.20260—
+4K260369Dynamis Robotic Surgical SystemLEM Surgical AG20260—
+4K261665CORUS™ Navigation System-GNProvidence Medical Technology, Inc.20260—
+4K253966PERLA® TL Posterior Thoraco-lumbar Fixation SystemSpineart SA20260—
+4K253940M.U.S.T. Pedicle Screw System - ExtensionMedacta International S.A.20260—
+4K253615Invictus Bands SystemAlphatec Spine, Inc.20260—