510(k) Report

Devices descending from K013823

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

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+5K161842Overwatch Spine SystemAmendia, Inc.201661
+5K162143FixxSure® X-LinkInnovasis, Inc.20160—
+5K161151Spinal fixation systemCanwell Medical Co., Ltd.20161—
+5K161591QUARTEX™ Occipito-Cervico-Thoracic Spinal System, Globus Navigation InstrumentsGlobus Medical, Inc.201678—
+5K161535SeaSpine® NewPort™ Spinal SystemSeaSpine Orthopedics Corporation201614—
+5K161914Genesys Spine TiLock Cortical Spinal SystemGenesys Spine20161—
+5K161694Threshold™ Pedicular Fixation SystemSpineology, Inc.20163—
+5K160902Mariner Pedicle Screw SystemSeaSpine Orthopedics Corporation201660—
+5K160980Threshold Pedicular Fixation System, Palisade Pedicular Fixation SystemSpineology, Inc.20166—
+5K160226JAZZ CLAW System (hooks and rods) and JAZZ CLAW connectorImplanet, S.A.20161—
+5K153404Zavation Spinal SystemZavation, LLC20161—
+5K153370Caspian OCT/MESA Mini/DENALI Mini Spinal SystemK2m, Incorporated201617—
+5K151974Polaris Spinal SystemBiomet Spine201516—
+5K152039Genesys Spine TiLock2 Spinal SystemGenesys Spine20157—
+5K151727Everest Spinal SystemK2m, Inc.201511—
+5K150896Vitality Spinal Fixation SystemZimmer Spine, Inc.2015193
+5K151422Reform Pedicle Screw SystemPrecision Spine, Inc.201519—
+5K142835Iliad Pedicle Screw System and Zenius Pedicle Screw SystemMedyssey USA, Inc.20155—
+5K150449LITe Plate SystemStryker Corp.201524—
+5K143377PedFuse Pedicle Screw SystemSpinefrontier, Inc.20150—
+5K143633CREO Stabilization SystemGlobus Medical, Inc.2015158—
+5K143248Reform Pedicle Screw SystemPrecision Spine, Inc.201430—
+5K141850Flospine Pedicle Screw SystemFlospine20140—
+5K140260Skyhawk Lateral Plate SystemOrthofix, Inc.201414—
+5K133944Range, Spinal System, Everest Spinal SystemK2m, Inc.201433—
+5K131533Cayman MI Plate SystemK2m, Inc.201372—
+5K130302Spinevision Lumis Cannulated Polyaxial Pedicle Screw Fixation System, Spinevision…Spinevision S.A.20134—
+5K131343Reform Pedicle Screw SystemSpinal USA201331—
+5K130877Expedium Spine SystemMedos International SARL20138—
+5K130279Reform Pedicle Screw SystemSpinal USA201331—
+5K122877Range Spinal System, Small StatureK2m, Inc.201334—
+5K123373Nautilus Spinal SystemLife Spine201317—
+5K120099Range Spinal System (Mesa and Denali)K2m, Inc.201253—
+5K110551Expedium Spine SystemJohnson & Johnson20111—
+5K111957Polaris Spinal SystemBiomet Spine (Ebi, LLC)201176—
+5K110906Apex Spine SystemSpinecraft, LLC2011103—
+5K102870Exactech Proliant Polyaxial Pedicle Screw SystemExactech, Inc.20119—
+5K102701Viper Spine SystemDepuy Spine, Inc.2010184—
+5K101070Expedium Spine SystemMedos International SARL20102601
+5K092473Expedium Spine SystemDepuy Spine, Inc.2009263—
+5K090320Conquest Spinal SystemLife Spine20092—
+5K090648Viper 2 SystemDepuy Spine, Inc.2009337—
+5K073143Modified Vertiflex Spinal Screw SystemVertiflex, Inc.20080—
+5K073245Extended Vertiflex Spinal Screw SystemVertiflex, Inc.200810—
+6K252139Kentrospine Viktr-MIS® Pedicle screw systemRivarp Medical Pvt., Ltd.20260—
+6K253420Admiral ACP System; Explorer TO System; Laminoplasty System; Manta Ray TDF Spacer…SeaSpine Orthopedics Corporation20260—
+6K260369Dynamis Robotic Surgical SystemLEM Surgical AG20260—
+6K261665CORUS™ Navigation System-GNProvidence Medical Technology, Inc.20260—
+6K260015ANTERIS Thoracolumbar Plate SystemSpineCraft20260—
+6K251940PathLoc Lumbar Plate SystemL&K BIOMED Co., Ltd.20260—
+6K252597Valence Robotic Navigation System; Valence Robotic Navigation Instruments (For Use with…Alphatec Spine, Inc.20261—
+6K252205Curiteva Porous PEEK Cervical Interbody System; Curiteva Porous PEEK Lumbar Interbody…Curiteva, Inc.20260—
+6K252327CMORE® CT System; CMORE® CT System Navigated InstrumentsIcotec AG20251—
+6K250599ExcelsiusGPS™ InstrumentsGlobus Medical, Inc.20250—
+6K252737DeGen Medical Latitude-C AM Cervical Interbody Fusion SystemDegen Medical20250—
+6K252437JAZZ Spinal SystemImplanet20250—
+6K251060CORUS™ Navigation System-GXProvidence Medical Technology, Inc.20250—
+6K251804KHEIRON® Spinal Fixation System, including patient specific K-RODS.M.A.I.O20254—
+6K250908Virata Spinal Fixation SystemSeaSpine Orthopedics Corporation202521
+6K250637VCFix Spinal SystemAmber Implants20250—
+6K242674Freedom Posterior Cervical ScrewsSignature Orthopaedics Pty, Ltd.20250—
+6K243945ALARA BMA Neuro Access Kit (ALARA BMAN and ALARA BMAC Kit)SurGenTec, LLC20250—
+6K243249TriALTIS™ Spine SystemMedos International SARL20250—
+6K242516EUROPA™ Posterior Cervical Fusion SystemMiRus, LLC20242—
+6K241077DeGen Medical Patient Specific Implant (PSI) SystemDegen Medical20242—
+6K240233Pitkar Spinal Pedicle Screw SystemS.H.Pitkar Orthotools Pvt., Ltd.20240—
+6K240664ALARA BMA Neuro Access Kit (ALARA BMAN and ALARA BMAC Kit)SurGenTec, LLC20241—
+6K241892Cortera™ Spinal Fixation SystemXtant Medical Holdings, Inc.20242—
+6K233256Robotic Integration InstrumentsDePuy Synthes20240—
+6K233228Spine Navigation and Robotic-Assistance DeviceEcential Robotics202421
+6K241175MiRus MoRe Lumbar Plating SystemMiRus, LLC20240—
+6K240126ProAM ALIF SystemPro Surgical, Inc.20242—
+6K240846CarboClear® Hybrid Pedicle Screw System; CarboClear® Hybrid Navigated Instruments…CarboFix Orthopedics, Ltd.20242—
+6K233989CarboClear® Posterior Cervical Screw SystemCarboFix Orthopedics, Ltd.20242—
+6K231715MONDRIAN™ Anterior Lumbar Plate SystemCtl Medical Corporation20240—
+6K233684TriALTIS™ Spine SystemMedos International SARL20234—
+6K231743F3D Lateral Lumbar Interbody System, CL5 Lateral Lumbar Interbody System, and Oro…Corelink, LLC20233—
+6K231923Liberty SI Lateral Implant SystemSpinal Simplicity, LLC20230—
+6K231809Momentum® Posterior Spinal Fixation System with G21 V-STEADY Bone Cement; Momentum® MIS…Ulrich Medical USA20231—
+6K230961Zeus Spinal SystemShanghai Sanyou Medical Co, Ltd.20232—
+6K232413Fusion Robotic Navigation SystemAlphatec Spine, Inc.20232—
+6K231811Zavation Connector SystemZavation Medical Products, LLC20230—
+6K231839CastleLoc-P Anterior Cervical Plate System, AccelFix Lumbar Plate SystemL&K BIOMED Co., Ltd.20232—
+6K231280CarboClear® X Pedicle Screw System; CarboClear® X Navigated Instruments; CarboClear® X…CarboFix Orthopedics, Ltd.20234—
+6K222229Advanced LumFix Spinal Fixation SystemCG Bio Co., Ltd.20232—
+6K230565HILINE™ Fixation SystemGlobus Medical, Inc.20230—
+6K223765ATEC Lateral Navigation InstrumentsAlphatec Spine, Inc.202302
+6K223181NuVasive Reline SystemNu Vasive, Incorporated202311—
+6K221926Invictus® Bone Cement, Invictus Spinal Fixation SystemAlphatec Spine, Inc.202214—
+6K220843OAKTREE Anterior Lumbar Plate and Screw SystemOak Tree Engineering, LLC20220—
+6K221806TruLift Lateral Expandable Spacer System & Lateral Plate SystemLife Spine, Inc.20221—
+6K223070Remi Robotic Navigation SystemFusion Robotics, LLC20224—
+6K222270HEDRON Cervical Spacers, HEDRON Lumbar Spacers, SABLE Expandable Spacer, ExcelsiusGPS…Globus Medical, Inc.202223—
+6K221728Aviator® Anterior Cervical Plating (ACP) System, LITe® Plate System, DynaTran™ Anterior…Stryker Corporation20221—
+6K222698CUVIS-spineCurexo, Inc.20220—
+6K211027Altus Spine Pedicle Screw SystemAltus Partners, LLC20222—
+6K220888MySpine S2-SI Pedicle and Sacro-Iliac Screw Placement GuidesMedacta International S.A.20221—
+6K213491Universal Pilot Guidance Instrument SystemCtl Medical Corporation20220—
+6K212962TRELLIS™ SI Joint Fusion SystemOrthofundamentals, LLC20220—
+6K220324AccuFit Lateral 2-Hole PlatePrecision Spine, Inc.20223—