510(k) Report

Devices descending from K053115

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

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+8K250827aprevo® anterior lumbar interbody fusion device; aprevo® lateral lumbar interbody fusion…Carlsmed, Inc.20252—
+8K251080IdentiTi II Cervical Interbody SystemAlphatec Spine, Inc.20250—
+8K251617X-PAC® TLIF Expandable Posterior Cage System; X-PAC® LLIF Expandable Lateral Cage SystemExpanding Innovations, Inc.20250—
+8K250637VCFix Spinal SystemAmber Implants20250—
+8K243934Stable-L Lumbar Interbody SystemNexus Spine, LLC20250—
+8K243945ALARA BMA Neuro Access Kit (ALARA BMAN and ALARA BMAC Kit)SurGenTec, LLC20250—
+8K241783FortiVy™ OsteoVy™ Lumbar IBFVy Spine, LLC20250—
+8K243838NEXXT MATRIXX® SI SystemNexxt Spine20250—
+8K243565DYNAMIS™ SI Screw SystemPromethean Restorative, LLC20251—
+8K241375IdentiTi Porous Ti Interbody System; IdentiTi NanoTec Interbody System; IdentiTi…Alphatec Spine20253—
+8K243007CD Horizon™ Spinal SystemMedtronic Sofamor Danek USA, Inc.20243—
+8K242899NOVA Minimally Invasive SystemBaui Biotech Co., Ltd.20240—
+8K242147Calibrate LTX Interbody System; Calibrate NanoTec LTX Interbody SystemAlphatec Spine, Inc.20241—
+8K242042TriALTIS™ Spine SystemMedos International SARL20241—
+8K240664ALARA BMA Neuro Access Kit (ALARA BMAN and ALARA BMAC Kit)SurGenTec, LLC20241—
+8K240505Eminent Spine SI Screw SystemEminent Spine, LLC20241—
+8K240368E3D™-A Interbody SystemEvolution Spine20247—
+8K232628VADER® Pedicle SystemIcotec AG20241—
+8K233640Segmental Plating System (SPS);IdentiTi SPS Interbody System;IdentiTi NanoTec SPS…Alphatec Spine, Inc.20245—
+8K233443Vital™ Navigation SystemZimvie Spine (Zimmer Biomet Spine, Inc.)20230—
+8K232504Calibrate CCX Interbody SystemAlphatec Spine, Inc.202311
+8K231658VEOS Spinal Fixation SystemSpineway20230—
+8K232605Sacrix® Sacroiliac Joint Fusion Device System, Inspan® ScrewLES Fusion System, Invue®…Lesspine Innovations20230—
+8K232097IdentiTi ALIF Interbody SystemsAlphatec Spine, Inc.202371
+8K232141CD Horizon ModuLeX FNS Screw Set (Fenestrated Screw); CD Horizon ModuLeX Spinal System…Medtronic Sofamor Danek USA, Inc.20231—
+8K231438Calibrate PSX Interbody System, Calibrate NanoTec PSX Interbody SystemAlphatec Spine, Inc.20237—
+8K223806VERTICALE® Triangular Fixation SystemSilony Medical GmbH20230—
+8K223335SIRION Lateral Lumbar Interbody SystemAstura Medical20230—
+8K230565HILINE™ Fixation SystemGlobus Medical, Inc.20230—
+8K223611Calibrate LTX Interbody SystemAlphatec Spine, Inc.20237—
+8K223765ATEC Lateral Navigation InstrumentsAlphatec Spine, Inc.202302
+8K223494CD Horizon Spinal SystemMedtronic202317—
+8K222614Zavation Spinal SystemZavation Medical Products, LLC20223—
+8K222256BonOs® Inject Bone Cement; NEO Pedicle Screw System™Neo Medical SA20223—
+8K221049Zavation VariSync Plate System and VariSync Spacer SystemZavation Medical Products, LLC20226—
+8K220888MySpine S2-SI Pedicle and Sacro-Iliac Screw Placement GuidesMedacta International S.A.20221—
+8K212811Ti3Z Lumbar Interbody SystemZavation Medical Products, LLC20223—
+8K220096Genesys Spine 3DP Lumbar Interbody SystemGenesys Spine20220—
+8K213720Vital Navigation SystemZimvie (Zimmer Biomet Spine, Inc.)20220—
+8K211710Ascent POCT System, Centurion POCT System, Spinal Fixation System (SFS), Firebird Spinal…Orthofix, Inc.20212—
+8K211113Zavation Spinal SystemZavation Medical Products, LLC20214—
+8K211306LabyrinthZavation Medical Products, LLC20213—
+8K201926CarboClear® Pedicle Screw System, CarboClear® II Pedicle Screw SystemCarboFix Orthopedics, Ltd.202010—
+8K201240Mariner Cap SystemSeaSpine Orthopedics Corporation20200—
+8K191489Genesys Spine 3DP Cervical Interbody SystemGenesys Spine20207—
+8K191723ATEC IOM Accessory InstrumentsAlphatec Spine, Inc.20192—
+8K191217Jazz PFImplanet, S.A.20190—
+8K190751Connector SystemOrthofix, Inc.20193—
+8K190361Zavation Spinal SystemZavation Medical Products, LLC20190—
+8K181883FIREFLY® Midline Navigation GuideMighty Oak Medical, Inc.20184—
+8K180226TREND II Spinal Fixation System- STEP SeriesPaonan Biotech Co., Ltd.20181—
+8K181399FIREFLY® Pedicle Screw Navigation GuideMighty Oak Medical, Inc.20185—
+8K180198NuVasive® VuePoint® II OCT SystemNu Vasive, Incorporated20184—
+8K172105The Plateau-LO Spacer SystemLife Spine, Inc.20181—
+8K171894NuVasive® Precept™ Spinal SystemNu Vasive, Incorporated20170—
+8K160020Captiva Spine and CapLOX II/TowerLOX Pedicle Screw SystemCaptiva Spine20160—
+9K253802KHEIRON® Spinal Fixation System, including patient specific K-RODS.M.A.I.O20261—
+9K260011Foundation Surgical Navigated Lateral Disc Prep InstrumentsFoundation Surgical Group, Inc.20260—
+9K253472FIREFLY® Pedicle Screw Navigation GuideMighty Oak Medical20260—
+9K252088Firebird SI Navigation SystemOrthofix US, LLC20251—
+9K253331PressON Spinal Fixation SystemNexus Spine20250—
+9K250894Eminent Spine Posterior SI SystemEminent Spine20250—
+9K251965Proximity Anterior Cervical Plate System; Segmental Plating System (SPS)Alphatec Spine, Inc.20250—
+9K252113PRADO™ Lumbar Interbody Fusion SystemBethesda Medical Devices20250—
+9K251075DYNAMIS™ Implant SystemPromethean Restorative, LLC20250—
+9K243461Calibrate Interbody SystemsAlphatec Spine, Inc.20250—
+9K243908Tiger 2 SystemZavation Medical Products, LLC20251—
+9K243693NEO Pedicle Screw System™Neo Medical SA20240—
+9K241082INNOVERSE Navigation InstrumentsInnosys Co., Ltd.20240—
+9K233509Zavation IBF System, Zavation Varisync Plate System and Varisync Spacer System…Zavation Medical Products, LLC20241—
+9K233594Genesys Spine 3DP AIS-C II Cervical Interbody SystemGenesys Spine20232—
+9K231766Skyway Anterior Cervical Plate SystemKyocera Medical Technologies Inc. (KMTI)20233—
+9K230731Zavation ALIF SystemZavation Medical Products, LLC20232—
+9K213654NuVasive Reline Cervical SystemNu Vasive, Incorporated20221—
+9K211417F3D-C2 Cervical Stand-Alone SystemCorelink, LLC20223—
+9K211993Z-LINKPC SystemZavation Medical Products, LLC20210—
+9K203319SYMPHONY™ OCT SystemMedos International SARL20211—
+9K191553NuVaisve® Reline® Cervical SystemNu Vasive, Incorporated20192—
+9K182470Plateau Spacer SystemLife Spine20180—
+10K250769Dakota LP SystemPrecision Spine, Inc.20250—
+10K251735Stabilis SA Cervical Stand-Alone System (Various PNs)Acuity Surgical Devices, LLC20251—
+10K242483Genesys Spine AIS-C II Cervical Interbody Fusion SystemGenesys Spine20250—
+10K243015Skyway Anterior Cervical Plate SystemKyocera Medical Technologies, Inc.20242—
+10K233366SYMPHONY OCT SystemMedos International SARL20230—
+10K230329F3D Interbody SystemCorelink, LLC20230—
+10K221388NuVasive Reline Cervical SystemNu Vasive, Incorporated20220—
+11K254130C.A. Medical Interbody Fusion SystemC.A. Medical, LLC20260—
+11K250486Skyway Anterior Cervical Plate SystemKyocera Medical Technologies Inc. (KMTI)20251—
+12K261451ZSAlign Cervical Interbody SystemZSFab, Inc.20260—