510(k) Report

Devices descending from K013823

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

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+8K251117Cervical Spine Truss System (CSTS)4Web Medical20250—
+8K243802aprevo® anterior and lateral lumbar interbody fusion device, aprevo® anterior lumbar…Carlsmed, Inc.20253—
+8K243908Tiger 2 SystemZavation Medical Products, LLC20251—
+8K242260aprevo® Cervical ACDF; aprevo® Cervical ACDF-X; aprevo® Cervical ACDF-X NO CAMCarlsmed, Inc.20243—
+8K242364IdentiTi™ II Interbody SystemAlphatec Spine, Inc.20244—
+8K242069Eminent Spine Scoliosis Deformity Pedicle Screw SystemEminent Spine20240—
+8K241574iFuse TORQ® Implant SystemSI-BONE, Inc.20244—
+8K240685Salvo® Spine SystemSpine Wave, Inc.20242—
+8K233966Anterior Spine Truss System-Stand Alone (ASTS-SA)4Web Medical, Inc.20241—
+8K233951CD Horizon ModuLeX Spinal System (Shanks, Head Assemblies, and Set Screw)Medtronic Sofamor Danek USA, Inc.20245—
+8K232628VADER® Pedicle SystemIcotec AG20241—
+8K240201PathLoc SI Joint Fusion SystemL&K BIOMED Co., Ltd.20240—
+8K232432E3D™-A Interbody SystemEvolution Spine20248—
+8K222988neoWave LS Lumbar Straight, neoWave C Cervical, and Ti3D CervicalHt Medical D.B.A. Xenix Medical20232—
+8K223301ASTRA & AVANT Navigation Instruments System and ASTRA-OCT Navigation Instruments SystemSpinecraft, LLC20230—
+8K230851Kodiak Lumbar Spacer SystemMet One Technologies, LLC20230—
+8K223513UniVy™ OsteoVy™-Ti Cervical IBF SystemVy Spine, LLC20231—
+8K223708Entasis 3D Dual-Lead Sacroiliac Implant SystemCorelink, LLC20233—
+8K230063G Surgical Marksman Spinal Deformity SystemG Surgical, LLC20230—
+8K222774iFuse Bedrock Granite® Implant SystemSI-BONE, Inc.202220—
+8K222973IdentiTi and Transcend Interbody Systems: IndentiTi Cervical Porous Ti Interbody System…Alphatec Spine, Inc.202213—
+8K222028IdentiTi™ Porous Ti Interbody System, IdentiTi™ NanoTec™ Interbody System, Transcend™…Alphatec Spine202228—
+8K221905INERTIA CONNEXX Modular Pedicle Screw SystemNexxt Spine, LLC20221—
+8K221332OsteoCentric Spine MIS Pedicle Fastener SystemOsteoCentric Technologies20221—
+8K221244CD Horizon™ Spinal SystemMedtronic202220—
+8K212489BonOs Inject Bone Cement; NEO Pedicle Screw SystemNeo Medical SA20215—
+8K211474Kleiner KG2 SystemBAAT Medical Products B.V.20210—
+8K203023Pisces Spinal SystemOrtho Development Corporation20210—
+8K210061ProLift Lateral HELO FixatedLife Spine, Inc.20213—
+8K203319SYMPHONY™ OCT SystemMedos International SARL20211—
+8K202398Ti3Z Cervical Interbody SystemZavation Medical Products, LLC20219—
+8K203452Nano FortiFix® SystemNanovis, LLC20200—
+8K202305Zavation IBF SystemZavation Medical Products, LLC20209—
+8K201006K2M Navigation InstrumentsK2m, Inc.20200—
+8K193270CapLOX II®/TowerLOX® MIS Pedicle Screw SystemCaptiva Spine, Inc.20200—
+8K182987Genesys Spine 3DP Lumbar Interbody SystemGenesys Spine20199—
+8K192281AEGIS Anterior Lumbar Plate System, ALC Dynamized Fixation System, Anterior ISOLA Spine…Medos International SARL20190—
+8K191854Premia Spine XL InstrumentsPremia Spine, Ltd.20190—
+8K181281Altus Spine Pedicle Screw SystemAltus Partners, LLC20181—
+8K180475CapLOX II® / TowerLOX® MIS Pedicle Screw SystemCaptiva Spine, Inc.20180—
+8K180153X-spine Cortical Bone Screw SystemX-Spine Systems, Inc.20180—
+8K171421VERTICALE® Posterior Spinal Fixation System/VERTICALE® SystemSilony Medical GmbH20186—
+8K172417SILC® Fixation SystemGlobus Medical, Inc.20171—
+8K161225Paonan Armstrong Posterior Spinal Fixation SystemPaonan Biotech Co., Ltd.20172—
+8K162921Navigated Instrument SystemOrthofix, Inc.20175—
+8K161014NuVasive® Reline® SystemNu Vasive, Incorporated201648—
+8K161387Mont Blanc and Mont Blanc MIS Spinal SystemsSpineway SA20163—
+8K151116CapLOX II/TowerLOX Pedicle Screw SystemCaptiva Spine20153—
+8K140457Nautilus Spinal SystemLife Spine, Inc.20143—
+9K261020Symmetrix™ L Spinal SystemMedtronic Sofamor Danek USA, Inc.20260—
+9K253045“Socko” Vimax Spinal Fixation SystemSocko Medical Co., Ltd.20260—
+9K260385aprevo® anterior and lateral lumbar interbody system; aprevo® posterior and…Carlsmed, Inc.20260—
+9K260216CD Horizon™ ModuLeX™ Fenestrated Screw Set; CD Horizon™ ModuLeX™ Spinal SystemMedtronic Sofamor Danek USA, Inc.20260—
+9K252240Spectrum Spine Cervical Cage System; Spectrum Spine Lumbar Cage SystemSpectrum Spine20260—
+9K253583LUX Expandable Lumbar Interbody SystemXenix Medical20260—
+9K253488iFuse INTRA Ti™ Implant SystemSI-BONE, Inc.20260—
+9K253941CD Horizon™ ModuLeX™ Spinal System (LigaMAS Head Assembly)Medtronic Sofamor Danek USA, Inc.20260—
+9K250520OsteoCentric Navigated Instruments SystemOsteocentric Technologies, Inc.20250—
+9K253335CD Horizon™ Spinal SystemMedtronic Sofamor Danek USA, Inc.20250—
+9K250827aprevo® anterior lumbar interbody fusion device; aprevo® lateral lumbar interbody fusion…Carlsmed, Inc.20252—
+9K251080IdentiTi II Cervical Interbody SystemAlphatec Spine, Inc.20250—
+9K251617X-PAC® TLIF Expandable Posterior Cage System; X-PAC® LLIF Expandable Lateral Cage SystemExpanding Innovations, Inc.20250—
+9K243934Stable-L Lumbar Interbody SystemNexus Spine, LLC20250—
+9K241783FortiVy™ OsteoVy™ Lumbar IBFVy Spine, LLC20250—
+9K243838NEXXT MATRIXX® SI SystemNexxt Spine20250—
+9K243565DYNAMIS™ SI Screw SystemPromethean Restorative, LLC20251—
+9K241375IdentiTi Porous Ti Interbody System; IdentiTi NanoTec Interbody System; IdentiTi…Alphatec Spine20253—
+9K243007CD Horizon™ Spinal SystemMedtronic Sofamor Danek USA, Inc.20243—
+9K242147Calibrate LTX Interbody System; Calibrate NanoTec LTX Interbody SystemAlphatec Spine, Inc.20241—
+9K240505Eminent Spine SI Screw SystemEminent Spine, LLC20241—
+9K240368E3D™-A Interbody SystemEvolution Spine20247—
+9K233640Segmental Plating System (SPS);IdentiTi SPS Interbody System;IdentiTi NanoTec SPS…Alphatec Spine, Inc.20245—
+9K233366SYMPHONY OCT SystemMedos International SARL20230—
+9K232504Calibrate CCX Interbody SystemAlphatec Spine, Inc.202311
+9K232605Sacrix® Sacroiliac Joint Fusion Device System, Inspan® ScrewLES Fusion System, Invue®…Lesspine Innovations20230—
+9K232097IdentiTi ALIF Interbody SystemsAlphatec Spine, Inc.202371
+9K232141CD Horizon ModuLeX FNS Screw Set (Fenestrated Screw); CD Horizon ModuLeX Spinal System…Medtronic Sofamor Danek USA, Inc.20231—
+9K231438Calibrate PSX Interbody System, Calibrate NanoTec PSX Interbody SystemAlphatec Spine, Inc.20237—
+9K223806VERTICALE® Triangular Fixation SystemSilony Medical GmbH20230—
+9K223335SIRION Lateral Lumbar Interbody SystemAstura Medical20230—
+9K223611Calibrate LTX Interbody SystemAlphatec Spine, Inc.20237—
+9K223494CD Horizon Spinal SystemMedtronic202317—
+9K222256BonOs® Inject Bone Cement; NEO Pedicle Screw System™Neo Medical SA20223—
+9K221049Zavation VariSync Plate System and VariSync Spacer SystemZavation Medical Products, LLC20226—
+9K212811Ti3Z Lumbar Interbody SystemZavation Medical Products, LLC20223—
+9K220096Genesys Spine 3DP Lumbar Interbody SystemGenesys Spine20220—
+9K211306LabyrinthZavation Medical Products, LLC20213—
+9K191489Genesys Spine 3DP Cervical Interbody SystemGenesys Spine20207—
+9K180226TREND II Spinal Fixation System- STEP SeriesPaonan Biotech Co., Ltd.20181—
+9K180198NuVasive® VuePoint® II OCT SystemNu Vasive, Incorporated20184—
+9K172105The Plateau-LO Spacer SystemLife Spine, Inc.20181—
+9K171894NuVasive® Precept™ Spinal SystemNu Vasive, Incorporated20170—
+9K160020Captiva Spine and CapLOX II/TowerLOX Pedicle Screw SystemCaptiva Spine20160—
+10K253802KHEIRON® Spinal Fixation System, including patient specific K-RODS.M.A.I.O20261—
+10K260011Foundation Surgical Navigated Lateral Disc Prep InstrumentsFoundation Surgical Group, Inc.20260—
+10K253331PressON Spinal Fixation SystemNexus Spine20250—
+10K250894Eminent Spine Posterior SI SystemEminent Spine20250—
+10K251965Proximity Anterior Cervical Plate System; Segmental Plating System (SPS)Alphatec Spine, Inc.20250—
+10K252113PRADO™ Lumbar Interbody Fusion SystemBethesda Medical Devices20250—
+10K251075DYNAMIS™ Implant SystemPromethean Restorative, LLC20250—