510(k) Report

Devices descending from K050461

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

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+9K253169Duet™ Spinal Fixation SystemBox Spine, LLC20261—
+9K253488iFuse INTRA Ti™ Implant SystemSI-BONE, Inc.20260—
+9K253941CD Horizon™ ModuLeX™ Spinal System (LigaMAS Head Assembly)Medtronic Sofamor Danek USA, Inc.20260—
+9K253876HEDRON™ Cervical Spacers (HEDRON C-MIS™ Spacer)Globus Medical, Inc.20251—
+9K250520OsteoCentric Navigated Instruments SystemOsteocentric Technologies, Inc.20250—
+9K253335CD Horizon™ Spinal SystemMedtronic Sofamor Danek USA, Inc.20250—
+9K252437JAZZ Spinal SystemImplanet20250—
+9K250637VCFix Spinal SystemAmber Implants20250—
+9K243419Altus Spine Navigation SystemAltus Partners, LLC20250—
+9K243945ALARA BMA Neuro Access Kit (ALARA BMAN and ALARA BMAC Kit)SurGenTec, LLC20250—
+9K243838NEXXT MATRIXX® SI SystemNexxt Spine20250—
+9K243565DYNAMIS™ SI Screw SystemPromethean Restorative, LLC20251—
+9K243635aprevo® anterior lumbar interbody fusion device with interfixationCarlsmed, Inc.20245—
+9K243007CD Horizon™ Spinal SystemMedtronic Sofamor Danek USA, Inc.20243—
+9K242899NOVA Minimally Invasive SystemBaui Biotech Co., Ltd.20240—
+9K242364IdentiTi™ II Interbody SystemAlphatec Spine, Inc.20244—
+9K234035COSINE™ SpacerGlobus Medical, Inc.20240—
+9K241846E3D™-C Interbody SystemEvolution Spine20246—
+9K240664ALARA BMA Neuro Access Kit (ALARA BMAN and ALARA BMAC Kit)SurGenTec, LLC20241—
+9K234077SPIRA® Anterior Lumbar SpacersCamber Spine Technologies20240—
+9K240505Eminent Spine SI Screw SystemEminent Spine, LLC20241—
+9K233989CarboClear® Posterior Cervical Screw SystemCarboFix Orthopedics, Ltd.20242—
+9K233332Statera-C™ Spinal SystemK&J Consulting Corp.20230—
+9K233443Vital™ Navigation SystemZimvie Spine (Zimmer Biomet Spine, Inc.)20230—
+9K231658VEOS Spinal Fixation SystemSpineway20230—
+9K230961Zeus Spinal SystemShanghai Sanyou Medical Co, Ltd.20232—
+9K232605Sacrix® Sacroiliac Joint Fusion Device System, Inspan® ScrewLES Fusion System, Invue®…Lesspine Innovations20230—
+9K232141CD Horizon ModuLeX FNS Screw Set (Fenestrated Screw); CD Horizon ModuLeX Spinal System…Medtronic Sofamor Danek USA, Inc.20231—
+9K223806VERTICALE® Triangular Fixation SystemSilony Medical GmbH20230—
+9K231280CarboClear® X Pedicle Screw System; CarboClear® X Navigated Instruments; CarboClear® X…CarboFix Orthopedics, Ltd.20234—
+9K222229Advanced LumFix Spinal Fixation SystemCG Bio Co., Ltd.20232—
+9K230565HILINE™ Fixation SystemGlobus Medical, Inc.20230—
+9K223765ATEC Lateral Navigation InstrumentsAlphatec Spine, Inc.202302
+9K223837SPIRA®-C Integrated Fixation SystemCamber Spine Technologies20230—
+9K223494CD Horizon Spinal SystemMedtronic202317—
+9K222789VADER® Pedicle System, G21 CementIcotec AG202352
+9K222614Zavation Spinal SystemZavation Medical Products, LLC20223—
+9K222256BonOs® Inject Bone Cement; NEO Pedicle Screw System™Neo Medical SA20223—
+9K221403Cortera Spinal Fixation SystemSurgalign Spine Technologies202232
+9K220888MySpine S2-SI Pedicle and Sacro-Iliac Screw Placement GuidesMedacta International S.A.20221—
+9K220341ARx Modular Spinal SystemLife Spine, Inc.20221—
+9K213720Vital Navigation SystemZimvie (Zimmer Biomet Spine, Inc.)20220—
+9K211710Ascent POCT System, Centurion POCT System, Spinal Fixation System (SFS), Firebird Spinal…Orthofix, Inc.20212—
+9K203023Pisces Spinal SystemOrtho Development Corporation20210—
+9K211113Zavation Spinal SystemZavation Medical Products, LLC20214—
+9K200922Altus Spine HA Pedicle Screw SystemAltus Partners, LLC20213—
+9K203163ARx Illiac Spinal Screw SystemLife Spine, Inc.20205—
+9K203056Invictus™ Spinal Fixation SystemAlphatec Spine, Inc.202061—
+9K202327Invictus™ OsseoScrew® SystemAlphatec Spine, Inc.20200—
+9K201006K2M Navigation InstrumentsK2m, Inc.20200—
+9K201926CarboClear® Pedicle Screw System, CarboClear® II Pedicle Screw SystemCarboFix Orthopedics, Ltd.202010—
+9K201240Mariner Cap SystemSeaSpine Orthopedics Corporation20200—
+9K191723ATEC IOM Accessory InstrumentsAlphatec Spine, Inc.20192—
+9K190526High V+ Bone Cement, CarboClear® Fenestrated Pedicle ScrewsCarboFix Orthopedics, Ltd.201928—
+9K191217Jazz PFImplanet, S.A.20190—
+9K191045Salvo™ Spine SystemSpine Wave, Inc.20195—
+9K190751Connector SystemOrthofix, Inc.20193—
+9K190361Zavation Spinal SystemZavation Medical Products, LLC20190—
+9K182508Saxxony™ Posterior Cervical Thoracic SystemNexxt Spine, LLC20184—
+9K181883FIREFLY® Midline Navigation GuideMighty Oak Medical, Inc.20184—
+9K180226TREND II Spinal Fixation System- STEP SeriesPaonan Biotech Co., Ltd.20181—
+9K181399FIREFLY® Pedicle Screw Navigation GuideMighty Oak Medical, Inc.20185—
+9K181350ASTRA-OCT Spine SystemSpinecraft, LLC20180—
+9K181188EVEREST Spinal SystemK2m, Inc.20186—
+9K180198NuVasive® VuePoint® II OCT SystemNu Vasive, Incorporated20184—
+9K172105The Plateau-LO Spacer SystemLife Spine, Inc.20181—
+9K171894NuVasive® Precept™ Spinal SystemNu Vasive, Incorporated20170—
+9K171509Iliad® Pedicle Screw System and Zenius® Pedicle Screw SystemMedyssey USA, Inc.20171—
+9K171438Palisade™ Pedicular Fixation SystemSpineology, Inc.20171—
+9K161591QUARTEX™ Occipito-Cervico-Thoracic Spinal System, Globus Navigation InstrumentsGlobus Medical, Inc.201678—
+9K160020Captiva Spine and CapLOX II/TowerLOX Pedicle Screw SystemCaptiva Spine20160—
+9K153370Caspian OCT/MESA Mini/DENALI Mini Spinal SystemK2m, Incorporated201617—
+10K262712Duet™ Spinal Fixation SystemDuet Spine Holdings, LLC20260—
+10K261882Pisces-SC Standalone Cervical Interbody SystemOsseus Fusions Systems, LLC20260—
+10K261205SPINEART Navigation Instrument SystemSpineart SA20260—
+10K262094E3D™-C Interbody SystemEvolution Spine20260—
+10K261020Symmetrix™ L Spinal SystemMedtronic Sofamor Danek USA, Inc.20260—
+10K253802KHEIRON® Spinal Fixation System, including patient specific K-RODS.M.A.I.O20261—
+10K260036NeckTune™ 3D SA Cervical CageMedyssey Co, Ltd.20260—
+10K260011Foundation Surgical Navigated Lateral Disc Prep InstrumentsFoundation Surgical Group, Inc.20260—
+10K253472FIREFLY® Pedicle Screw Navigation GuideMighty Oak Medical20260—
+10K254105Hive™ Standalone Cervical System and Hive™ C Interbody SystemNanoHive Medical, LLC20260—
+10K260038E3D™-C Interbody SystemEvolution Spine20261—
+10K252894aprevo® cervical interbody systemCarlsmed, Inc.20261—
+10K252088Firebird SI Navigation SystemOrthofix US, LLC20251—
+10K253331PressON Spinal Fixation SystemNexus Spine20250—
+10K250894Eminent Spine Posterior SI SystemEminent Spine20250—
+10K251575IdentiTi™ II ALIF Standalone Interbody System; Transcend™ ALIF Standalone Interbody SystemAlphatec Spine20250—
+10K251080IdentiTi II Cervical Interbody SystemAlphatec Spine, Inc.20250—
+10K251617X-PAC® TLIF Expandable Posterior Cage System; X-PAC® LLIF Expandable Lateral Cage SystemExpanding Innovations, Inc.20250—
+10K242674Freedom Posterior Cervical ScrewsSignature Orthopaedics Pty, Ltd.20250—
+10K250582COLONNADE Posterior Screw Fixation SystemCG Bio Co., Ltd.20250—
+10K251075DYNAMIS™ Implant SystemPromethean Restorative, LLC20250—
+10K243802aprevo® anterior and lateral lumbar interbody fusion device, aprevo® anterior lumbar…Carlsmed, Inc.20253—
+10K243908Tiger 2 SystemZavation Medical Products, LLC20251—
+10K243693NEO Pedicle Screw System™Neo Medical SA20240—
+10K241892Cortera™ Spinal Fixation SystemXtant Medical Holdings, Inc.20242—
+10K241082INNOVERSE Navigation InstrumentsInnosys Co., Ltd.20240—
+10K232628VADER® Pedicle SystemIcotec AG20241—
+10K211027Altus Spine Pedicle Screw SystemAltus Partners, LLC20222—