510(k) Report

Devices descending from K111449

236 later devices reach Revolve Additional Implants through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K171651Excelsius GPSGlobus Medical, Inc.2017691
+1K122226Revere Stabilization SystemGlobus Medical, Inc.2012225—
+1K121922Beacon Stabilization SystemGlobus Medical, Inc.20129—
+2K262067iFuse Granite Onyx™ Implant SystemSI-BONE, Inc.20260—
+2K254148VERTICALE GPS InstrumentsSilony Medical GmbH20260—
+2K251780iGPS Navigation InstrumentsSI-BONE, Inc.20250—
+2K251073Innovasis Navigation Instruments (Vector G-E Navigation Instruments and the Excella G-E…Innovasis, Inc.202501
+2K241525ExcelsiusXR™Globus Medical, Inc.20250—
+2K243326Dynamis Robotic Surgical SystemLEM Surgical AG20251—
+2K243514Salvo® Robotic Navigation InstrumentsSpine Wave, Inc.20250—
+2K243814NuVasive Pulse SystemGlobus Medical, Inc.20250—
+2K243671ExcelsiusGPS® InstrumentsGlobus Medical, Inc.20240—
+2K240160EGPS Navigated InstrumentsAstura Medical20240—
+2K240721ExcelsiusFlex™Globus Medical, Inc.20240—
+2K240951Invictus Robotic Navigation InstrumentsAlphatec Spine20242—
+2K240568DuraPro™ Oscillating SystemGlobus Medical, Inc.20240—
+2K231850QUARTEX® Occipito-Cervico-Thoracic Spinal System ExcelsiusGPS® InstrumentsGlobus Medical, Inc.20242—
+2K233638VERZA™ High Speed DrillsGlobus Medical, Inc.20241—
+2K231443Mini-OSTEO Pedicle Fixation SystemOsteomed Indústria E Comércio DE Implantes Ltda20230—
+2K231494CoreLink Robotic Navigation InstrumentsCorelink, LLC20230—
+2K232044Invictus Robotic Navigation InstrumentsAlphatec Spine, Inc.20233—
+2K223558CUVIS-spineCurexo, Inc.20230—
+2K223350Remi Robotic Navigation SystemFusion Robotics, LLC20230—
+2K220862E-GPS Navigated InstrumentsPrecision Spine, Inc.20227—
+2K211616ExcelsiusHubGlobus Medical, Inc.20219Class I
+2K201569CUVIS-spineCurexo, Inc.20212—
+2K202184Practical Navigation Surgical Guidance System (PNSGS)Practical Navigation, LLC20215—
+2K203153CREO Stabilization System, Navigation Instruments, ExcelsiusGPSGlobus Medical, Inc.20211—
+2K200047ExcelsiusGPS Cranial 1.0 ModuleGlobus Medical, Inc.202053
+2K191100ExcelsiusGPS Spine 1.1 Interbody ModuleGlobus Medical, Inc.201942—
+2K183119SI-LOK® Sacroiliac Joint Fixation System, Navigation Instruments, ExcelsiusGPS®…Globus Medical, Inc.20192—
+2K182000AQrate Robotic Assistance SystemGlobus Medical, Inc.20191—
+2K180210CREO® Stabilization SystemGlobus Medical, Inc.201888—
+2K173508Everest Spinal SystemK2m20189—
+2K152148Fortress Pedicular Fixation SystemSpineology, Inc.20158—
+2K141804Polaris Spinal System - HA CoatedBiomet Spine, LLC201421—
+2K133350Revere Stabilization SystemGlobus Medical, Inc.201493—
+2K132403Annextm Adjacent Level SystemSpine Wave, Inc.20142—
+2K124058Creo Stabilization SystemGlobus Medical, Inc.2013172—
+2K123783Ellipse Occipito-Cerico-Thoracic Spinal System and Capitol ImplantsGlobus Medical, Inc.201397—
+3K260369Dynamis Robotic Surgical SystemLEM Surgical AG20260—
+3K261665CORUS™ Navigation System-GNProvidence Medical Technology, Inc.20260—
+3K253739SCRIPT™ Rods, CREO™ Stabilization System, REVERE® Stabilization System, REVERE® 4.5…Globus Medical, Inc.20260—
+3K252597Valence Robotic Navigation System; Valence Robotic Navigation Instruments (For Use with…Alphatec Spine, Inc.20261—
+3K252327CMORE® CT System; CMORE® CT System Navigated InstrumentsIcotec AG20251—
+3K250599ExcelsiusGPS™ InstrumentsGlobus Medical, Inc.20250—
+3K251060CORUS™ Navigation System-GXProvidence Medical Technology, Inc.20250—
+3K251131Annex® 2 Adjacent Level SystemSpine Wave, Inc.20250—
+3K243259MASADA Modular Spinal Fixation SystemAstura Medical20250—
+3K243281LOCK-IN Spinal Fixation SystemLock-In USA Corp20240—
+3K242361OZARK Cervical Plate System; PYRENEES® Cervical Plate System; EVEREST® Spinal System…Stryker Spine20241—
+3K233256Robotic Integration InstrumentsDePuy Synthes20240—
+3K233228Spine Navigation and Robotic-Assistance DeviceEcential Robotics202421
+3K231923Liberty SI Lateral Implant SystemSpinal Simplicity, LLC20230—
+3K232719ProMIS Extension Rod SystemPremia Spine, Ltd.20230—
+3K231694MASADA Modular Spinal Fixation SystemAstura Medical20232—
+3K232586Rexious Spinal Fixation System, Statera™ Spinal System, Statera-M™ Spinal SystemK&J Consulting Corp.20230—
+3K232341CarboClear® Pedicle Screw SystemCarboFix Orthopedics, Ltd.20234—
+3K223070Remi Robotic Navigation SystemFusion Robotics, LLC20224—
+3K222270HEDRON Cervical Spacers, HEDRON Lumbar Spacers, SABLE Expandable Spacer, ExcelsiusGPS…Globus Medical, Inc.202223—
+3K222698CUVIS-spineCurexo, Inc.20220—
+3K212962TRELLIS™ SI Joint Fusion SystemOrthofundamentals, LLC20220—
+3K212066Adena-Zina SystemShanghai Sanyou Medical Co, Ltd.20213—
+3K210275Polaris Spinal SystemZimmer Biomet Spine, Inc.20210—
+3K200937ACURA Stabilization SystemIndius Medical Technologies Pvt., Ltd.20200—
+3K192938Invictus™ Spinal Fixation SystemAlphatec Spine, Inc.201969—
+3K191835CREO Stabilization System, Navigation Instruments, ExcelsiusGPS InstrumentsGlobus Medical, Inc.20192—
+3K190376PASS LP Spinal SystemMedicrea International SA201915
+3K182478Whistler Modular Pedicle Screw SystemEvolution Spine, LLC20196—
+3K182954Salvo™ Spine SystemSpine Wave, Inc.20186—
+3K181139OLYMPIC Posterior Spinal Fixation SystemAstura Medical, LLC20188—
+3K181068CREO® Stabilization System, REVERE® Stabilization SystemGlobus Medical, Inc.20182—
+3K181119Range (Denali and Mesa) Spinal SystemsK2m, Inc.20185—
+3K180376K2M Patient Specific RodsK2m, Inc.20182—
+3K170268Fortress™ Pedicular Fixation SystemSpineology, Inc.20171—
+3K161694Threshold™ Pedicular Fixation SystemSpineology, Inc.20163—
+3K160980Threshold Pedicular Fixation System, Palisade Pedicular Fixation SystemSpineology, Inc.20166—
+3K151422Reform Pedicle Screw SystemPrecision Spine, Inc.201519—
+3K150552ELLIPSE and PROTEX CT OCCIPITO-CERVICO-THORACIC SPINAL SYSTEMSGlobus Medical, Inc.2015961
+3K150647Polyscrew Pedicle Screw SystemNew Era Orthopedics, LLC201501
+3K141222Nautilus Spinal System and Solstice Oct SystemLife Spine, Inc.201513—
+3K143633CREO Stabilization SystemGlobus Medical, Inc.2015158—
+3K141253New Era Orthopaedics Polyscrew Pedicle Screw SystemNew Era Orthopaedics, LLC201511
+3K133366Orthros Posterior Stabilization SystemCamber Spine20142—
+4K261113Op.n™ Spine Navigation and Robotic GuidanceEcential Robotics20261—
+4K261284Invictus® Small Stature Spinal Fixation System; Invictus® 2.0 Spinal Fixation SystemAlphatec Spine, Inc.20260—
+4K253401SCRIPT™ Implant SystemGlobus Medical, Inc.20260—
+4K254045CarboClear® Posterior Cervical Screw System; CarboClear® Hybrid Posterior Cervical Screw…CarboFix Orthopedics, Ltd.20260—
+4K253545Vulcan Spinal SystemK2m, Inc.20260—
+4K253876HEDRON™ Cervical Spacers (HEDRON C-MIS™ Spacer)Globus Medical, Inc.20251—
+4K252346OLYMPIC Posterior Spinal Fixation System; MASADA Modular Spinal Fixation SystemAstura Medical20250—
+4K252737DeGen Medical Latitude-C AM Cervical Interbody Fusion SystemDegen Medical20250—
+4K243635aprevo® anterior lumbar interbody fusion device with interfixationCarlsmed, Inc.20245—
+4K242764MediRod Pedicle Screw SystemCmf Medicon Surgical, Inc.20240—
+4K234035COSINE™ SpacerGlobus Medical, Inc.20240—
+4K241846E3D™-C Interbody SystemEvolution Spine20246—
+4K233793CarboClear® X Pedicle Screw SystemCarboFix Orthopedics, Ltd.20241—
+4K234077SPIRA® Anterior Lumbar SpacersCamber Spine Technologies20240—
+4K241519Invictus® Small Stature Spinal Fixation SystemAlphatec Spine, Inc.20242—
+4K234048M.U.S.T. Pedicle Screw System - ExtensionMedacta International S.A.20241—