510(k) Report

Devices descending from K052761

735 later devices reach Modification to: Xia 4.5 Spinal System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+5K121670Medyssey Cannulated Pedicle ScrewMedyssey Co, Ltd.201311—
+5K122226Revere Stabilization SystemGlobus Medical, Inc.2012225—
+5K122145Lanx Spinal Fixation SystemLanx, Inc.201271
+5K120564Calypso SystemHogan Lovells US LLP201216—
+5K121130Polaris Spinal System-Ballista Spinal RodsBiomet Spine20121—
+5K121020Viper SystemDepuy Spine, Inc.201294—
+5K113044Synthes MirsSynthes Spine2011933
+5K112551S4 Spinal SystemAesculap Implant System, Inc.201161—
+5K111957Polaris Spinal SystemBiomet Spine (Ebi, LLC)201176—
+5K110906Apex Spine SystemSpinecraft, LLC2011103—
+5K110216Expedium System, Viper SystemDepuy Spine, Inc.20114—
+5K103133Veper System, Expedium SystemDepuy Spine, Inc.20110—
+5K101993Viper System, Expedium SystemDepuy Spine, Inc.20101628
+5K100845Pathfinder II, Minimally Invasie Pedicle Screw System Model 3500 SeriesZimmer Spine, Inc.201045
+6K262193RIVA® Posterior Fixation System with NanoACTIV Surface Technology; RIVA® Anchor…Xenix Medical20260—
+6K253943Tiger 2 SystemZavation Medical Products, LLC20260—
+6K253420Admiral ACP System; Explorer TO System; Laminoplasty System; Manta Ray TDF Spacer…SeaSpine Orthopedics Corporation20260—
+6K260286Dynamo™ Spinal Cement; Salvo® Spine SystemSpine Wave, Inc.20260—
+6K260786KHEIRON® Spinal Fixation System, including patient specific K-RODS.M.A.I.O20261—
+6K254148VERTICALE GPS InstrumentsSilony Medical GmbH20260—
+6K252885OLYMPIC Posterior Spinal Fixation System; MASADA Modular Spinal Fixation SystemAstura Medical20260—
+6K253721KHEIRON® Spinal Fixation System, including patient specific K-RODS.M.A.I.O20252—
+6K252729Universal Spinal SystemDouble Medical Technology, Inc.20250—
+6K252327CMORE® CT System; CMORE® CT System Navigated InstrumentsIcotec AG20251—
+6K242827A8 INTEGR8™ Porous Pedicle ScrewsAllumin8, Inc.20251—
+6K251780iGPS Navigation InstrumentsSI-BONE, Inc.20250—
+6K251073Innovasis Navigation Instruments (Vector G-E Navigation Instruments and the Excella G-E…Innovasis, Inc.202501
+6K241525ExcelsiusXR™Globus Medical, Inc.20250—
+6K250845Curiteva Porous PEEK Standalone ALIF SystemCuriteva, Inc.20251—
+6K250866Sovereign Posterior Cervical SystemMet One Technologies, LLC20251—
+6K243326Dynamis Robotic Surgical SystemLEM Surgical AG20251—
+6K243514Salvo® Robotic Navigation InstrumentsSpine Wave, Inc.20250—
+6K242900VADER® Pedicle System and VADER®one Pedicle SystemIcotec AG20250—
+6K243814NuVasive Pulse SystemGlobus Medical, Inc.20250—
+6K243671ExcelsiusGPS® InstrumentsGlobus Medical, Inc.20240—
+6K243281LOCK-IN Spinal Fixation SystemLock-In USA Corp20240—
+6K240160EGPS Navigated InstrumentsAstura Medical20240—
+6K233793CarboClear® X Pedicle Screw SystemCarboFix Orthopedics, Ltd.20241—
+6K240326Solar™ Lumbar Interbody Fusion SystemDegen Medical, Inc.20244—
+6K241519Invictus® Small Stature Spinal Fixation SystemAlphatec Spine, Inc.20242—
+6K240721ExcelsiusFlex™Globus Medical, Inc.20240—
+6K240951Invictus Robotic Navigation InstrumentsAlphatec Spine20242—
+6K240568DuraPro™ Oscillating SystemGlobus Medical, Inc.20240—
+6K232256Alcantara Thoracolumbar Plate SystemCamber Spine Technologies, LLC20240—
+6K231850QUARTEX® Occipito-Cervico-Thoracic Spinal System ExcelsiusGPS® InstrumentsGlobus Medical, Inc.20242—
+6K233638VERZA™ High Speed DrillsGlobus Medical, Inc.20241—
+6K233944CarboClear® X Pedicle Screw System; CarboClear® X Navigated InstrumentsCarboFix Orthopedics, Ltd.20243—
+6K233455ARx MIS Spinal Screw SystemLife Spine, Inc.20230—
+6K232292Peridot-EX Expandable Intervertebral Body Fusion SystemGbs Commonwealth Co., Ltd.20230—
+6K232044Invictus Robotic Navigation InstrumentsAlphatec Spine, Inc.20233—
+6K232650KHEIRON® Spinal Fixation System, including patient specific K-RODS.M.A.I.O20236—
+6K231479TriALTIS Spine SystemMedos International SARL20238—
+6K232218Zenius™ Spinal SystemMedyssey USA, Inc.20230—
+6K231098LineSider® Spinal SystemIntegrity Implants, Inc.20233—
+6K223558CUVIS-spineCurexo, Inc.20230—
+6K231199Solar Lumbar Interbody Fusion SystemDegen Medical20235—
+6K230762EDEN Spinal Fixation MIS SystemJmt Co., Ltd.20230—
+6K223350Remi Robotic Navigation SystemFusion Robotics, LLC20230—
+6K223413Pisces™-SA STANDALONE ALIF Interbody SystemOsseus Fusion Systems20233—
+6K221926Invictus® Bone Cement, Invictus Spinal Fixation SystemAlphatec Spine, Inc.202214—
+6K213196MARVEL™ Growing RodsGlobus Medical, Inc.20220—
+6K220862E-GPS Navigated InstrumentsPrecision Spine, Inc.20227—
+6K220195iFuse Bedrock Granite™ Implant SystemSI-BONE, Inc.202232—
+6K220570M.U.S.T. MINI Posterior Cervical Screws System ExtensionMedacta International S.A.20220—
+6K214006Invictus® Spinal Fixation SystemAlphatec Spine, Inc.202216—
+6K213281PASS LP™ Spinal System, CD Horizon™ Spinal SystemMedicrea International SA20220—
+6K212088Integrity Implants Navigated InstrumentsIntegrity Implants, Inc.20210—
+6K211616ExcelsiusHubGlobus Medical, Inc.20219Class I
+6K211205Prase-C Anterior Cervical Plate SystemGbs Commonwealth Co., Ltd.20210—
+6K211238SpineJack Expansion Kit, Vertaplex Radiopaque Bone Cement, Vertaplex HV Radiopaque Bone…Stryker Instruments20212—
+6K201569CUVIS-spineCurexo, Inc.20212—
+6K210539CoreLink Midline Fixation SystemCorelink, LLC20214—
+6K210275Polaris Spinal SystemZimmer Biomet Spine, Inc.20210—
+6K201420Republic Spine Dark Star Spinal SystemRepublic Spine, LLC20212—
+6K202184Practical Navigation Surgical Guidance System (PNSGS)Practical Navigation, LLC20215—
+6K203153CREO Stabilization System, Navigation Instruments, ExcelsiusGPSGlobus Medical, Inc.20211—
+6K203367LineSider™ Spinal SystemIntegrity Implants, Inc.202054
+6K203149M.U.S.T. MINI Posterior Cervical Screws SystemMedacta International S.A.20200—
+6K200794AccelFix Spinal Fixation SystemL&K BIOMED Co., Ltd.20208—
+6K200047ExcelsiusGPS Cranial 1.0 ModuleGlobus Medical, Inc.202053
+6K193211Nano FortiFix® SystemNanovis Spine, LLC20201—
+6K200130M.U.S.T. MINI Posterior Cervical Screws SystemMedacta International S.A.20206—
+6K193465CorticaLINK Spinal Fusion PlatformSpine Smith Holdings, LLC20200—
+6K192680Percusys® Plus Pedicle Screw SystemJoimax GmbH20190—
+6K193219G Surgical Marksman SystemG Surgical, LLC20191—
+6K191932Momentum™ Posterior Spinal Fixation SystemUlrich Medical USA20192—
+6K191810Curiteva Pedicle Screw SystemCuriteva, Inc.20190—
+6K191575ARx Spinal SystemLife Spine, Inc.201910—
+6K191100ExcelsiusGPS Spine 1.1 Interbody ModuleGlobus Medical, Inc.201942—
+6K183119SI-LOK® Sacroiliac Joint Fixation System, Navigation Instruments, ExcelsiusGPS®…Globus Medical, Inc.20192—
+6K182000AQrate Robotic Assistance SystemGlobus Medical, Inc.20191—
+6K182837M.U.S.T. Mini ExtensionMedacta International S.A.20191—
+6K183117PathLoc-L MIS Spinal SystemL&K BIOMED Co., Ltd.20184—
+6K181603EVEREST Spinal System, RANGE (MESA and DENALI) Spinal System, CASPIAN OCT (MESA Mini and…K2m, Inc.20185—
+6K181119Range (Denali and Mesa) Spinal SystemsK2m, Inc.20185—
+6K173472MySpine Pedicle Screw Placement Guides – MC and Drill Pilot InstrumentsMedacta International S.A.20185—
+6K180376K2M Patient Specific RodsK2m, Inc.20182—
+6K180210CREO® Stabilization SystemGlobus Medical, Inc.201888—
+6K172115Navigated Instrument SystemOrthofix, Inc.20184—
+6K173484CorticaLINK Spinal Fusion PlatformLinkspine, Inc.20170—