510(k) Report

Devices descending from K050461

742 later devices reach Xia 4.5 Spinal System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+6K151704Diplomat® Spinal SystemSignus Medizintechnik GmbH20164—
+6K153428Firebird Spinal Fixation System, Phoenix MIS Spinal Fixation SystemOrthofix, Inc.2016731
+6K153664M.U.S.T. Pedicle Screw SystemMedacta International201624—
+6K151770Libra Pedicle Screw SystemSpinal Balance, Inc.20151—
+6K151488Firebird Spinal Fixation System/Phoenix MIS Spinal Fixation SystemOrthofix, Inc.2015781
+6K150325Range/Denali/Mesa Spinal SystemK2m, Inc.201512—
+6K143230Palladian Lumbar Pedicle Screw SystemNeurostructures, Inc.20150—
+6K143350Nile Alternative FixationK2m, Inc.201510—
+6K141222Nautilus Spinal System and Solstice Oct SystemLife Spine, Inc.201513—
+6K143200MIS Z-Pedicle Screw SystemZ-Medical GmbH & Co. KG201514—
+6K141186Firebird Spinal Fixation SystemOrthofix, Inc.20153—
+6K141282PGS 5.5 MM Cannulated Pedicle ScrewPinnacle Spine Group20141—
+6K141291Vertiform Posterior Fixation SystemNext Orthosurgical20142—
+6K141988M.U.S.T Pedicle Screw SystemMedacta International201426—
+6K140400ES2 Neuromonitoring Accessory InstrumentsStryker Corporation20149—
+6K132788Myspine Pedicle Screw Placement GuidesMedacta International201412—
+6K140123Polaris Spinal System -Translation ScrewEbi, LLC2014221
+6K133944Range, Spinal System, Everest Spinal SystemK2m, Inc.201433—
+6K133746Polaris Spinal SystemBiomet Spine (Aka Ebi, LLC)2014671
+6K133103Aversion Pedicle Screw SystemK7, LLC20140—
+6K133369Tiger Spine SystemCorelink, LLC201429—
+6K131250Tiger Spine SystemCorelink, LLC201340—
+6K131615Polaris Spinal SystemBiomet Spine (Aka Ebi, LLC)201370—
+6K131784Range Spinal SystemK2m, Inc.201334—
+6K131810Osseus Black Diamond Pedicle Screw SystemOsseus Fusion Systems, LLC201314—
+6K131343Reform Pedicle Screw SystemSpinal USA201331—
+6K130279Reform Pedicle Screw SystemSpinal USA201331—
+6K131030Range Spinal SystemK2m, Inc.201334—
+6K130330Range Spinal SystemK2m, Inc.201336—
+6K123939S4 Spinal SystemAesculap Implant Systems, Inc.20133—
+6K123412Range Spinal System, Small Strature ComponentsK2m, Inc.201334—
+6K121670Medyssey Cannulated Pedicle ScrewMedyssey Co, Ltd.201311—
+6K122226Revere Stabilization SystemGlobus Medical, Inc.2012225—
+6K122145Lanx Spinal Fixation SystemLanx, Inc.201271
+6K120564Calypso SystemHogan Lovells US LLP201216—
+6K121130Polaris Spinal System-Ballista Spinal RodsBiomet Spine20121—
+6K121020Viper SystemDepuy Spine, Inc.201294—
+6K113044Synthes MirsSynthes Spine2011933
+6K112551S4 Spinal SystemAesculap Implant System, Inc.201161—
+6K111957Polaris Spinal SystemBiomet Spine (Ebi, LLC)201176—
+6K110906Apex Spine SystemSpinecraft, LLC2011103—
+6K110216Expedium System, Viper SystemDepuy Spine, Inc.20114—
+6K103133Veper System, Expedium SystemDepuy Spine, Inc.20110—
+6K101993Viper System, Expedium SystemDepuy Spine, Inc.20101628
+6K100845Pathfinder II, Minimally Invasie Pedicle Screw System Model 3500 SeriesZimmer Spine, Inc.201045
+7K260286Dynamo™ Spinal Cement; Salvo® Spine SystemSpine Wave, Inc.20260—
+7K254148VERTICALE GPS InstrumentsSilony Medical GmbH20260—
+7K252885OLYMPIC Posterior Spinal Fixation System; MASADA Modular Spinal Fixation SystemAstura Medical20260—
+7K253721KHEIRON® Spinal Fixation System, including patient specific K-RODS.M.A.I.O20252—
+7K252327CMORE® CT System; CMORE® CT System Navigated InstrumentsIcotec AG20251—
+7K242827A8 INTEGR8™ Porous Pedicle ScrewsAllumin8, Inc.20251—
+7K251780iGPS Navigation InstrumentsSI-BONE, Inc.20250—
+7K241525ExcelsiusXR™Globus Medical, Inc.20250—
+7K251644ProAM ALIF SystemPro Surgical, Inc.20250—
+7K250866Sovereign Posterior Cervical SystemMet One Technologies, LLC20251—
+7K243326Dynamis Robotic Surgical SystemLEM Surgical AG20251—
+7K250667DeGen Medical Patient Specific Implant (PSI) SystemDegen Medical20251—
+7K243514Salvo® Robotic Navigation InstrumentsSpine Wave, Inc.20250—
+7K242900VADER® Pedicle System and VADER®one Pedicle SystemIcotec AG20250—
+7K243814NuVasive Pulse SystemGlobus Medical, Inc.20250—
+7K243671ExcelsiusGPS® InstrumentsGlobus Medical, Inc.20240—
+7K243281LOCK-IN Spinal Fixation SystemLock-In USA Corp20240—
+7K242517ProAM ACDF SystemPro Surgical, Inc.20240—
+7K240160EGPS Navigated InstrumentsAstura Medical20240—
+7K242042TriALTIS™ Spine SystemMedos International SARL20241—
+7K233793CarboClear® X Pedicle Screw SystemCarboFix Orthopedics, Ltd.20241—
+7K241519Invictus® Small Stature Spinal Fixation SystemAlphatec Spine, Inc.20242—
+7K240721ExcelsiusFlex™Globus Medical, Inc.20240—
+7K240951Invictus Robotic Navigation InstrumentsAlphatec Spine20242—
+7K240568DuraPro™ Oscillating SystemGlobus Medical, Inc.20240—
+7K231850QUARTEX® Occipito-Cervico-Thoracic Spinal System ExcelsiusGPS® InstrumentsGlobus Medical, Inc.20242—
+7K233638VERZA™ High Speed DrillsGlobus Medical, Inc.20241—
+7K233944CarboClear® X Pedicle Screw System; CarboClear® X Navigated InstrumentsCarboFix Orthopedics, Ltd.20243—
+7K233455ARx MIS Spinal Screw SystemLife Spine, Inc.20230—
+7K232292Peridot-EX Expandable Intervertebral Body Fusion SystemGbs Commonwealth Co., Ltd.20230—
+7K232044Invictus Robotic Navigation InstrumentsAlphatec Spine, Inc.20233—
+7K232650KHEIRON® Spinal Fixation System, including patient specific K-RODS.M.A.I.O20236—
+7K232218Zenius™ Spinal SystemMedyssey USA, Inc.20230—
+7K231098LineSider® Spinal SystemIntegrity Implants, Inc.20233—
+7K223558CUVIS-spineCurexo, Inc.20230—
+7K230762EDEN Spinal Fixation MIS SystemJmt Co., Ltd.20230—
+7K223350Remi Robotic Navigation SystemFusion Robotics, LLC20230—
+7K221926Invictus® Bone Cement, Invictus Spinal Fixation SystemAlphatec Spine, Inc.202214—
+7K213196MARVEL™ Growing RodsGlobus Medical, Inc.20220—
+7K220862E-GPS Navigated InstrumentsPrecision Spine, Inc.20227—
+7K220195iFuse Bedrock Granite™ Implant SystemSI-BONE, Inc.202232—
+7K220570M.U.S.T. MINI Posterior Cervical Screws System ExtensionMedacta International S.A.20220—
+7K214006Invictus® Spinal Fixation SystemAlphatec Spine, Inc.202216—
+7K212088Integrity Implants Navigated InstrumentsIntegrity Implants, Inc.20210—
+7K211616ExcelsiusHubGlobus Medical, Inc.20219Class I
+7K211238SpineJack Expansion Kit, Vertaplex Radiopaque Bone Cement, Vertaplex HV Radiopaque Bone…Stryker Instruments20212—
+7K201569CUVIS-spineCurexo, Inc.20212—
+7K210539CoreLink Midline Fixation SystemCorelink, LLC20214—
+7K210275Polaris Spinal SystemZimmer Biomet Spine, Inc.20210—
+7K201420Republic Spine Dark Star Spinal SystemRepublic Spine, LLC20212—
+7K202184Practical Navigation Surgical Guidance System (PNSGS)Practical Navigation, LLC20215—
+7K203153CREO Stabilization System, Navigation Instruments, ExcelsiusGPSGlobus Medical, Inc.20211—
+7K203367LineSider™ Spinal SystemIntegrity Implants, Inc.202054
+7K203149M.U.S.T. MINI Posterior Cervical Screws SystemMedacta International S.A.20200—
+7K200794AccelFix Spinal Fixation SystemL&K BIOMED Co., Ltd.20208—