510(k) Report

Devices descending from K053115

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

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+5K160722CorticaLINK Spinal Fusion PlatformFacetlink Dba Linkspine20162—
+5K160362Z-Span Plate SystemZavation, LLC20163—
+5K153428Firebird Spinal Fixation System, Phoenix MIS Spinal Fixation SystemOrthofix, Inc.2016731
+5K153525Seneka II Polyscrew Pedicle Fixation SystemSenecka Spine20160—
+5K153664M.U.S.T. Pedicle Screw SystemMedacta International201624—
+5K151770Libra Pedicle Screw SystemSpinal Balance, Inc.20151—
+5K151974Polaris Spinal SystemBiomet Spine201516—
+5K150896Vitality Spinal Fixation SystemZimmer Spine, Inc.2015193
+5K151488Firebird Spinal Fixation System/Phoenix MIS Spinal Fixation SystemOrthofix, Inc.2015781
+5K150856Reform Pedicle Screw SystemPrecision Spine, Inc.201526—
+5K150325Range/Denali/Mesa Spinal SystemK2m, Inc.201512—
+5K143230Palladian Lumbar Pedicle Screw SystemNeurostructures, Inc.20150—
+5K143350Nile Alternative FixationK2m, Inc.201510—
+5K143200MIS Z-Pedicle Screw SystemZ-Medical GmbH & Co. KG201514—
+5K141186Firebird Spinal Fixation SystemOrthofix, Inc.20153—
+5K141282PGS 5.5 MM Cannulated Pedicle ScrewPinnacle Spine Group20141—
+5K141873Range/Mesa/Denali Spinal SystemK2m, Inc.201430—
+5K141291Vertiform Posterior Fixation SystemNext Orthosurgical20142—
+5K141988M.U.S.T Pedicle Screw SystemMedacta International201426—
+5K140400ES2 Neuromonitoring Accessory InstrumentsStryker Corporation20149—
+5K141147Range Spinal SystemK2m, Inc.20141—
+5K132788Myspine Pedicle Screw Placement GuidesMedacta International201412—
+5K133743Baxano Surgical Mis Spinal SystemBaxano Surgical, Inc.20140—
+5K133103Aversion Pedicle Screw SystemK7, LLC20140—
+5K133369Tiger Spine SystemCorelink, LLC201429—
+5K132760Nautilus Spinal SystemLife Spine, Inc.201314—
+5K131250Tiger Spine SystemCorelink, LLC201340—
+5K131784Range Spinal SystemK2m, Inc.201334—
+5K131810Osseus Black Diamond Pedicle Screw SystemOsseus Fusion Systems, LLC201314—
+5K131343Reform Pedicle Screw SystemSpinal USA201331—
+5K130279Reform Pedicle Screw SystemSpinal USA201331—
+5K131030Range Spinal SystemK2m, Inc.201334—
+5K130330Range Spinal SystemK2m, Inc.201336—
+5K123939S4 Spinal SystemAesculap Implant Systems, Inc.20133—
+5K123412Range Spinal System, Small Strature ComponentsK2m, Inc.201334—
+5K122145Lanx Spinal Fixation SystemLanx, Inc.201271
+5K120564Calypso SystemHogan Lovells US LLP201216—
+5K121130Polaris Spinal System-Ballista Spinal RodsBiomet Spine20121—
+5K121020Viper SystemDepuy Spine, Inc.201294—
+5K113058Tiger Spine SystemCorelink, LLC201281—
+5K113044Synthes MirsSynthes Spine2011933
+5K112551S4 Spinal SystemAesculap Implant System, Inc.201161—
+5K111957Polaris Spinal SystemBiomet Spine (Ebi, LLC)201176—
+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—
+6K261113Op.n™ Spine Navigation and Robotic GuidanceEcential Robotics20261—
+6K253420Admiral ACP System; Explorer TO System; Laminoplasty System; Manta Ray TDF Spacer…SeaSpine Orthopedics Corporation20260—
+6K260286Dynamo™ Spinal Cement; Salvo® Spine SystemSpine Wave, Inc.20260—
+6K260571SIMPACT Sacroiliac Joint Fixation System GX Navigation InstrumentsLife Spine, Inc.20260—
+6K261112CastleLoc-P Anterior Cervical Plate SystemL&K BIOMED Co., Ltd.20260—
+6K253401SCRIPT™ Implant SystemGlobus Medical, Inc.20260—
+6K260786KHEIRON® Spinal Fixation System, including patient specific K-RODS.M.A.I.O20261—
+6K254045CarboClear® Posterior Cervical Screw System; CarboClear® Hybrid Posterior Cervical Screw…CarboFix Orthopedics, Ltd.20260—
+6K253169Duet™ Spinal Fixation SystemBox Spine, LLC20261—
+6K253201Lumbar Spine Truss System - Plating Solution (LSTS-PS)4Web, Inc.20260—
+6K252885OLYMPIC Posterior Spinal Fixation System; MASADA Modular Spinal Fixation SystemAstura Medical20260—
+6K252205Curiteva Porous PEEK Cervical Interbody System; Curiteva Porous PEEK Lumbar Interbody…Curiteva, Inc.20260—
+6K253876HEDRON™ Cervical Spacers (HEDRON C-MIS™ Spacer)Globus Medical, Inc.20251—
+6K252781MSFX Mikron Peek CagesMikron Makina Sanayi VE Tic. Ltd. Sti.20251—
+6K253721KHEIRON® Spinal Fixation System, including patient specific K-RODS.M.A.I.O20252—
+6K253200Cervical Spine Truss System - Stand Alone (CSTS-SA)4Web Medical, Inc.20250—
+6K252729Universal Spinal SystemDouble Medical Technology, Inc.20250—
+6K242827A8 INTEGR8™ Porous Pedicle ScrewsAllumin8, Inc.20251—
+6K252737DeGen Medical Latitude-C AM Cervical Interbody Fusion SystemDegen Medical20250—
+6K251575IdentiTi™ II ALIF Standalone Interbody System; Transcend™ ALIF Standalone Interbody SystemAlphatec Spine20250—
+6K252437JAZZ Spinal SystemImplanet20250—
+6K251502TruLift® Lateral Expandable Spacer & Lateral Buttress Plate SystemLife Spine, Inc.20250—
+6K250866Sovereign Posterior Cervical SystemMet One Technologies, LLC20251—
+6K250582COLONNADE Posterior Screw Fixation SystemCG Bio Co., Ltd.20250—
+6K242900VADER® Pedicle System and VADER®one Pedicle SystemIcotec AG20250—
+6K242297Reform Pedicle Screw SystemPrecision Spine, Inc.20240—
+6K243635aprevo® anterior lumbar interbody fusion device with interfixationCarlsmed, Inc.20245—
+6K241468Vertiwedge® Intraosseous SystemFoundation Surgical Group, Inc.20241—
+6K241077DeGen Medical Patient Specific Implant (PSI) SystemDegen Medical20242—
+6K241487Interwedge® Standalone LateralFoundation Surgical Group, Inc.20241—
+6K234035COSINE™ SpacerGlobus Medical, Inc.20240—
+6K241846E3D™-C Interbody SystemEvolution Spine20246—
+6K234077SPIRA® Anterior Lumbar SpacersCamber Spine Technologies20240—
+6K240392JAZZ Spinal SystemImplanet20241—
+6K240126ProAM ALIF SystemPro Surgical, Inc.20242—
+6K232292Peridot-EX Expandable Intervertebral Body Fusion SystemGbs Commonwealth Co., Ltd.20230—
+6K232650KHEIRON® Spinal Fixation System, including patient specific K-RODS.M.A.I.O20236—
+6K232275Invictus® Spinal Fixation SystemAlphatec Spine, Inc.202311—
+6K231739Cervical Spine Truss System (CSTS)4Web Medical, Inc.20232—
+6K231479TriALTIS Spine SystemMedos International SARL20238—
+6K232154MiRus 3DR Lateral Lumbar Interbody Fusion System with Integrated Plate FixationMiRus, LLC20230—
+6K232413Fusion Robotic Navigation SystemAlphatec Spine, Inc.20232—
+6K231098LineSider® Spinal SystemIntegrity Implants, Inc.20233—
+6K231840CastleLoc-S Posterior Cervical Fixation SystemL&K BIOMED Co., Ltd.20230—
+6K231841PathLoc SI Joint Fusion SystemL&K BIOMED Co., Ltd.20231—
+6K231280CarboClear® X Pedicle Screw System; CarboClear® X Navigated Instruments; CarboClear® X…CarboFix Orthopedics, Ltd.20234—
+6K230762EDEN Spinal Fixation MIS SystemJmt Co., Ltd.20230—
+6K230880CoreLink Navigation InstrumentsCorelink, LLC20230—
+6K230766Altus Spine Monaco Pedicle Screw SystemAltus Spine20231—
+6K230424Omnia Medical Coupler-A™ Anterior Lumbar Plate System; Omnia Medical Coupler-L™ Lateral…Omnia Medical, LLC20230—
+6K223837SPIRA®-C Integrated Fixation SystemCamber Spine Technologies20230—
+6K221490Tritanium C Anterior Cervical Cage, Tritanium PL Cage, Tritanium TL Curved Posterior…Stryker Spine20231—