510(k) Report

Devices descending from K002858

749 later devices reach Xia Spine System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+7K170821ChoiceSpine™ Proliant® Posterior Pedicle Screw and Hook Fixation SystemChoicespine, LP20170—
+7K171170M.U.S.T. Pedicle Screw System Extension - Straight Connectors and Additional ScrewsMedacta International S.A.201723—
+7K170108Xultan 5.5 Pedicle Screw SystemMet One Technologies20172—
+7K170163Erisma® LP Spinal Fixation SystemClariance, Sas20172—
+7K162061M.U.S.T. Pedicle Screw SystemMedacta International S.A.201615—
+7K161028K2M Growing Spine SystemK2m, Inc.20163—
+7K160722CorticaLINK Spinal Fusion PlatformFacetlink Dba Linkspine20162—
+7K153428Firebird Spinal Fixation System, Phoenix MIS Spinal Fixation SystemOrthofix, Inc.2016731
+7K153664M.U.S.T. Pedicle Screw SystemMedacta International201624—
+7K151488Firebird Spinal Fixation System/Phoenix MIS Spinal Fixation SystemOrthofix, Inc.2015781
+7K150325Range/Denali/Mesa Spinal SystemK2m, Inc.201512—
+7K143230Palladian Lumbar Pedicle Screw SystemNeurostructures, Inc.20150—
+7K143350Nile Alternative FixationK2m, Inc.201510—
+7K141222Nautilus Spinal System and Solstice Oct SystemLife Spine, Inc.201513—
+7K143200MIS Z-Pedicle Screw SystemZ-Medical GmbH & Co. KG201514—
+7K141186Firebird Spinal Fixation SystemOrthofix, Inc.20153—
+7K141282PGS 5.5 MM Cannulated Pedicle ScrewPinnacle Spine Group20141—
+7K141804Polaris Spinal System - HA CoatedBiomet Spine, LLC201421—
+7K141291Vertiform Posterior Fixation SystemNext Orthosurgical20142—
+7K141988M.U.S.T Pedicle Screw SystemMedacta International201426—
+7K132788Myspine Pedicle Screw Placement GuidesMedacta International201412—
+7K133944Range, Spinal System, Everest Spinal SystemK2m, Inc.201433—
+7K133103Aversion Pedicle Screw SystemK7, LLC20140—
+7K133369Tiger Spine SystemCorelink, LLC201429—
+7K131250Tiger Spine SystemCorelink, LLC201340—
+7K131784Range Spinal SystemK2m, Inc.201334—
+7K131810Osseus Black Diamond Pedicle Screw SystemOsseus Fusion Systems, LLC201314—
+7K131030Range Spinal SystemK2m, Inc.201334—
+7K130330Range Spinal SystemK2m, Inc.201336—
+7K123412Range Spinal System, Small Strature ComponentsK2m, Inc.201334—
+7K122226Revere Stabilization SystemGlobus Medical, Inc.2012225—
+7K122145Lanx Spinal Fixation SystemLanx, Inc.201271
+7K121130Polaris Spinal System-Ballista Spinal RodsBiomet Spine20121—
+7K121020Viper SystemDepuy Spine, Inc.201294—
+7K113044Synthes MirsSynthes Spine2011933
+7K110906Apex Spine SystemSpinecraft, LLC2011103—
+7K110216Expedium System, Viper SystemDepuy Spine, Inc.20114—
+7K103133Veper System, Expedium SystemDepuy Spine, Inc.20110—
+7K101993Viper System, Expedium SystemDepuy Spine, Inc.20101628
+7K100845Pathfinder II, Minimally Invasie Pedicle Screw System Model 3500 SeriesZimmer Spine, Inc.201045
+8K260286Dynamo™ Spinal Cement; Salvo® Spine SystemSpine Wave, Inc.20260—
+8K261112CastleLoc-P Anterior Cervical Plate SystemL&K BIOMED Co., Ltd.20260—
+8K251940PathLoc Lumbar Plate SystemL&K BIOMED Co., Ltd.20260—
+8K254148VERTICALE GPS InstrumentsSilony Medical GmbH20260—
+8K252885OLYMPIC Posterior Spinal Fixation System; MASADA Modular Spinal Fixation SystemAstura Medical20260—
+8K253721KHEIRON® Spinal Fixation System, including patient specific K-RODS.M.A.I.O20252—
+8K242827A8 INTEGR8™ Porous Pedicle ScrewsAllumin8, Inc.20251—
+8K251780iGPS Navigation InstrumentsSI-BONE, Inc.20250—
+8K241525ExcelsiusXR™Globus Medical, Inc.20250—
+8K251644ProAM ALIF SystemPro Surgical, Inc.20250—
+8K250866Sovereign Posterior Cervical SystemMet One Technologies, LLC20251—
+8K243326Dynamis Robotic Surgical SystemLEM Surgical AG20251—
+8K250667DeGen Medical Patient Specific Implant (PSI) SystemDegen Medical20251—
+8K243514Salvo® Robotic Navigation InstrumentsSpine Wave, Inc.20250—
+8K243814NuVasive Pulse SystemGlobus Medical, Inc.20250—
+8K243671ExcelsiusGPS® InstrumentsGlobus Medical, Inc.20240—
+8K242517ProAM ACDF SystemPro Surgical, Inc.20240—
+8K240160EGPS Navigated InstrumentsAstura Medical20240—
+8K242042TriALTIS™ Spine SystemMedos International SARL20241—
+8K241519Invictus® Small Stature Spinal Fixation SystemAlphatec Spine, Inc.20242—
+8K240721ExcelsiusFlex™Globus Medical, Inc.20240—
+8K240951Invictus Robotic Navigation InstrumentsAlphatec Spine20242—
+8K240568DuraPro™ Oscillating SystemGlobus Medical, Inc.20240—
+8K231850QUARTEX® Occipito-Cervico-Thoracic Spinal System ExcelsiusGPS® InstrumentsGlobus Medical, Inc.20242—
+8K232628VADER® Pedicle SystemIcotec AG20241—
+8K233638VERZA™ High Speed DrillsGlobus Medical, Inc.20241—
+8K233455ARx MIS Spinal Screw SystemLife Spine, Inc.20230—
+8K232044Invictus Robotic Navigation InstrumentsAlphatec Spine, Inc.20233—
+8K232650KHEIRON® Spinal Fixation System, including patient specific K-RODS.M.A.I.O20236—
+8K232275Invictus® Spinal Fixation SystemAlphatec Spine, Inc.202311—
+8K231098LineSider® Spinal SystemIntegrity Implants, Inc.20233—
+8K223558CUVIS-spineCurexo, Inc.20230—
+8K230721ATEC Lateral Plate SystemAlphatec Spine, Inc.20230—
+8K222097OLYMPIC Deformity Band SystemAstura Medical20233—
+8K223350Remi Robotic Navigation SystemFusion Robotics, LLC20230—
+8K213196MARVEL™ Growing RodsGlobus Medical, Inc.20220—
+8K220862E-GPS Navigated InstrumentsPrecision Spine, Inc.20227—
+8K220195iFuse Bedrock Granite™ Implant SystemSI-BONE, Inc.202232—
+8K220570M.U.S.T. MINI Posterior Cervical Screws System ExtensionMedacta International S.A.20220—
+8K212088Integrity Implants Navigated InstrumentsIntegrity Implants, Inc.20210—
+8K211616ExcelsiusHubGlobus Medical, Inc.20219Class I
+8K201569CUVIS-spineCurexo, Inc.20212—
+8K210539CoreLink Midline Fixation SystemCorelink, LLC20214—
+8K201420Republic Spine Dark Star Spinal SystemRepublic Spine, LLC20212—
+8K202184Practical Navigation Surgical Guidance System (PNSGS)Practical Navigation, LLC20215—
+8K203153CREO Stabilization System, Navigation Instruments, ExcelsiusGPSGlobus Medical, Inc.20211—
+8K203367LineSider™ Spinal SystemIntegrity Implants, Inc.202054
+8K203149M.U.S.T. MINI Posterior Cervical Screws SystemMedacta International S.A.20200—
+8K200047ExcelsiusGPS Cranial 1.0 ModuleGlobus Medical, Inc.202053
+8K193211Nano FortiFix® SystemNanovis Spine, LLC20201—
+8K200130M.U.S.T. MINI Posterior Cervical Screws SystemMedacta International S.A.20206—
+8K193465CorticaLINK Spinal Fusion PlatformSpine Smith Holdings, LLC20200—
+8K192680Percusys® Plus Pedicle Screw SystemJoimax GmbH20190—
+8K193219G Surgical Marksman SystemG Surgical, LLC20191—
+8K191575ARx Spinal SystemLife Spine, Inc.201910—
+8K191100ExcelsiusGPS Spine 1.1 Interbody ModuleGlobus Medical, Inc.201942—
+8K183119SI-LOK® Sacroiliac Joint Fixation System, Navigation Instruments, ExcelsiusGPS®…Globus Medical, Inc.20192—
+8K182000AQrate Robotic Assistance SystemGlobus Medical, Inc.20191—
+8K182837M.U.S.T. Mini ExtensionMedacta International S.A.20191—
+8K181603EVEREST Spinal System, RANGE (MESA and DENALI) Spinal System, CASPIAN OCT (MESA Mini and…K2m, Inc.20185—