510(k) Report

Devices descending from K124058

172 later devices reach Creo Stabilization System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K253739SCRIPT™ Rods, CREO™ Stabilization System, REVERE® Stabilization System, REVERE® 4.5…Globus Medical, Inc.20260—
+1K243259MASADA Modular Spinal Fixation SystemAstura Medical20250—
+1K243281LOCK-IN Spinal Fixation SystemLock-In USA Corp20240—
+1K231694MASADA Modular Spinal Fixation SystemAstura Medical20232—
+1K212066Adena-Zina SystemShanghai Sanyou Medical Co, Ltd.20213—
+1K203153CREO Stabilization System, Navigation Instruments, ExcelsiusGPSGlobus Medical, Inc.20211—
+1K191835CREO Stabilization System, Navigation Instruments, ExcelsiusGPS InstrumentsGlobus Medical, Inc.20192—
+1K190376PASS LP Spinal SystemMedicrea International SA201915
+1K181139OLYMPIC Posterior Spinal Fixation SystemAstura Medical, LLC20188—
+1K181068CREO® Stabilization System, REVERE® Stabilization SystemGlobus Medical, Inc.20182—
+1K180210CREO® Stabilization SystemGlobus Medical, Inc.201888—
+1K150647Polyscrew Pedicle Screw SystemNew Era Orthopedics, LLC201501
+1K143633CREO Stabilization SystemGlobus Medical, Inc.2015158—
+1K141253New Era Orthopaedics Polyscrew Pedicle Screw SystemNew Era Orthopaedics, LLC201511
+1K133366Orthros Posterior Stabilization SystemCamber Spine20142—
+2K252346OLYMPIC Posterior Spinal Fixation System; MASADA Modular Spinal Fixation SystemAstura Medical20250—
+2K242764MediRod Pedicle Screw SystemCmf Medicon Surgical, Inc.20240—
+2K230961Zeus Spinal SystemShanghai Sanyou Medical Co, Ltd.20232—
+2K231636LnK Spinal Fixation System /OpenLoc-L Spinal Fixation System, AccelFix Spinal Fixation…L&K BIOMED Co., Ltd.20232—
+2K230245LnK Spinal Fixation System/OpenLoc-L Spinal Fixation System; AccelFix Spinal Fixation…L&K BIOMED Co., Ltd.20233—
+2K213196MARVEL™ Growing RodsGlobus Medical, Inc.20220—
+2K213281PASS LP™ Spinal System, CD Horizon™ Spinal SystemMedicrea International SA20220—
+2K200937ACURA Stabilization SystemIndius Medical Technologies Pvt., Ltd.20200—
+2K192938Invictus™ Spinal Fixation SystemAlphatec Spine, Inc.201969—
+2K182478Whistler Modular Pedicle Screw SystemEvolution Spine, LLC20196—
+2K182954Salvo™ Spine SystemSpine Wave, Inc.20186—
+2K180980ORTHROS™ Posterior Stabilization System; ORTHROS™ MIS Posterior Stabilization SystemCamber Spine Technologies, LLC20181—
+2K171651Excelsius GPSGlobus Medical, Inc.2017691
+2K151196Nautilus Spinal SystemLife Spine, Inc.201512—
+3K262067iFuse Granite Onyx™ Implant SystemSI-BONE, Inc.20260—
+3K254148VERTICALE GPS InstrumentsSilony Medical GmbH20260—
+3K251780iGPS Navigation InstrumentsSI-BONE, Inc.20250—
+3K252437JAZZ Spinal SystemImplanet20250—
+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—
+3K240160EGPS Navigated InstrumentsAstura Medical20240—
+3K241519Invictus® Small Stature Spinal Fixation SystemAlphatec Spine, Inc.20242—
+3K240721ExcelsiusFlex™Globus Medical, Inc.20240—
+3K240951Invictus Robotic Navigation InstrumentsAlphatec Spine20242—
+3K240392JAZZ Spinal SystemImplanet20241—
+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—
+3K231494CoreLink Robotic Navigation InstrumentsCorelink, LLC20230—
+3K232044Invictus Robotic Navigation InstrumentsAlphatec Spine, Inc.20233—
+3K232311LnK Spinal Fixation System /OpenLoc-L Spinal Fixation System, AccelFix Spinal Fixation…L&K BIOMED Co., Ltd.20231—
+3K223558CUVIS-spineCurexo, Inc.20230—
+3K223350Remi Robotic Navigation SystemFusion Robotics, LLC20230—
+3K221403Cortera Spinal Fixation SystemSurgalign Spine Technologies202232
+3K220862E-GPS Navigated InstrumentsPrecision Spine, Inc.20227—
+3K220038Camber Spine Navigation SystemCamber Spine Technologies20220—
+3K211616ExcelsiusHubGlobus Medical, Inc.20219Class I
+3K202836GX Navigation Instrument SystemLife Spine, Inc.20211—
+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—
+3K200070ARx Spinal SystemLife Spine, Inc.20209—
+3K191575ARx Spinal SystemLife Spine, Inc.201910—
+3K191100ExcelsiusGPS Spine 1.1 Interbody ModuleGlobus Medical, Inc.201942—
+3K191045Salvo™ Spine SystemSpine Wave, Inc.20195—
+3K183430Modular Spinal Fixation SystemLife Spine, Inc.20192—
+3K183119SI-LOK® Sacroiliac Joint Fixation System, Navigation Instruments, ExcelsiusGPS®…Globus Medical, Inc.20192—
+3K182000AQrate Robotic Assistance SystemGlobus Medical, Inc.20191—
+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—
+4K260571SIMPACT Sacroiliac Joint Fixation System GX Navigation InstrumentsLife Spine, Inc.20260—
+4K261130AccelFix Spinal Fixation SystemL&K BIOMED Co., Ltd.20260—
+4K253940M.U.S.T. Pedicle Screw System - ExtensionMedacta International S.A.20260—
+4K253615Invictus Bands SystemAlphatec Spine, Inc.20260—
+4K252597Valence Robotic Navigation System; Valence Robotic Navigation Instruments (For Use with…Alphatec Spine, Inc.20261—
+4K252327CMORE® CT System; CMORE® CT System Navigated InstrumentsIcotec AG20251—
+4K250599ExcelsiusGPS™ InstrumentsGlobus Medical, Inc.20250—
+4K251060CORUS™ Navigation System-GXProvidence Medical Technology, Inc.20250—
+4K241892Cortera™ Spinal Fixation SystemXtant Medical Holdings, Inc.20242—
+4K233256Robotic Integration InstrumentsDePuy Synthes20240—
+4K233228Spine Navigation and Robotic-Assistance DeviceEcential Robotics202421
+4K231923Liberty SI Lateral Implant SystemSpinal Simplicity, LLC20230—
+4K223070Remi Robotic Navigation SystemFusion Robotics, LLC20224—
+4K222270HEDRON Cervical Spacers, HEDRON Lumbar Spacers, SABLE Expandable Spacer, ExcelsiusGPS…Globus Medical, Inc.202223—
+4K222698CUVIS-spineCurexo, Inc.20220—
+4K211027Altus Spine Pedicle Screw SystemAltus Partners, LLC20222—
+4K220341ARx Modular Spinal SystemLife Spine, Inc.20221—
+4K212962TRELLIS™ SI Joint Fusion SystemOrthofundamentals, LLC20220—
+4K220025ARx® Spinal SystemLife Spine, Inc.20220—
+4K213460Invictus Spinal Fixation SystemAlphatec Spine, Inc.202117—
+4K210549ARx Spinal SystemLife Spine, Inc.20211—
+4K203742IdentiTi ALIF Standalone Interbody SystemAlphatec Spine, Inc.202159—
+4K203163ARx Illiac Spinal Screw SystemLife Spine, Inc.20205—
+4K202476Salvo® Spine SystemSpine Wave, Inc.20204—