510(k) Report

Devices descending from K053115

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

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+7K260989Varion Thoracolumbar Fixation SystemKyocera Medical Technologies Inc. (KMTI)20260—
+7K260340HC Biologics Osteopoint Peek Cages, HC Biologics Osteopoint Cervical Peek Cages, HC…HC Biologics, LLC20260—
+7K254105Hive™ Standalone Cervical System and Hive™ C Interbody SystemNanoHive Medical, LLC20260—
+7K260038E3D™-C Interbody SystemEvolution Spine20261—
+7K252834Sacroiliac Joint Truss System (SJTS)4Web Medical20260—
+7K253748Life Spine ProLift & ProLift Lateral and ProLift Lateral Fixated Expandable Spacer SystemLife Spine, Inc.20260—
+7K252711Advantage-C™ Ti3D Cervical Interbody Fusion DeviceIntelivation Technologies20260—
+7K252894aprevo® cervical interbody systemCarlsmed, Inc.20261—
+7K253093Vital™ Spinal Fixation SystemHighridge Medical, LLC20250—
+7K251644ProAM ALIF SystemPro Surgical, Inc.20250—
+7K243419Altus Spine Navigation SystemAltus Partners, LLC20250—
+7K251117Cervical Spine Truss System (CSTS)4Web Medical20250—
+7K250667DeGen Medical Patient Specific Implant (PSI) SystemDegen Medical20251—
+7K243802aprevo® anterior and lateral lumbar interbody fusion device, aprevo® anterior lumbar…Carlsmed, Inc.20253—
+7K243249TriALTIS™ Spine SystemMedos International SARL20250—
+7K242517ProAM ACDF SystemPro Surgical, Inc.20240—
+7K242260aprevo® Cervical ACDF; aprevo® Cervical ACDF-X; aprevo® Cervical ACDF-X NO CAMCarlsmed, Inc.20243—
+7K242364IdentiTi™ II Interbody SystemAlphatec Spine, Inc.20244—
+7K242069Eminent Spine Scoliosis Deformity Pedicle Screw SystemEminent Spine20240—
+7K241574iFuse TORQ® Implant SystemSI-BONE, Inc.20244—
+7K240685Salvo® Spine SystemSpine Wave, Inc.20242—
+7K233966Anterior Spine Truss System-Stand Alone (ASTS-SA)4Web Medical, Inc.20241—
+7K233951CD Horizon ModuLeX Spinal System (Shanks, Head Assemblies, and Set Screw)Medtronic Sofamor Danek USA, Inc.20245—
+7K240201PathLoc SI Joint Fusion SystemL&K BIOMED Co., Ltd.20240—
+7K232432E3D™-A Interbody SystemEvolution Spine20248—
+7K233684TriALTIS™ Spine SystemMedos International SARL20234—
+7K231515MySpine Cervical GuidesMedacta International S.A.20230—
+7K222988neoWave LS Lumbar Straight, neoWave C Cervical, and Ti3D CervicalHt Medical D.B.A. Xenix Medical20232—
+7K231811Zavation Connector SystemZavation Medical Products, LLC20230—
+7K231483MySpine Unilateral GuidesMedacta International S.A.20230—
+7K223301ASTRA & AVANT Navigation Instruments System and ASTRA-OCT Navigation Instruments SystemSpinecraft, LLC20230—
+7K230851Kodiak Lumbar Spacer SystemMet One Technologies, LLC20230—
+7K222097OLYMPIC Deformity Band SystemAstura Medical20233—
+7K223513UniVy™ OsteoVy™-Ti Cervical IBF SystemVy Spine, LLC20231—
+7K223708Entasis 3D Dual-Lead Sacroiliac Implant SystemCorelink, LLC20233—
+7K230063G Surgical Marksman Spinal Deformity SystemG Surgical, LLC20230—
+7K222789VADER® Pedicle System, G21 CementIcotec AG202352
+7K222774iFuse Bedrock Granite® Implant SystemSI-BONE, Inc.202220—
+7K223294SpineJack® Expansion KitStryker Instruments20221—
+7K222973IdentiTi and Transcend Interbody Systems: IndentiTi Cervical Porous Ti Interbody System…Alphatec Spine, Inc.202213—
+7K222028IdentiTi™ Porous Ti Interbody System, IdentiTi™ NanoTec™ Interbody System, Transcend™…Alphatec Spine202228—
+7K221821ATEC IOM Accessory InstrumentsAlphatec Spine, Inc.20221—
+7K221905INERTIA CONNEXX Modular Pedicle Screw SystemNexxt Spine, LLC20221—
+7K221332OsteoCentric Spine MIS Pedicle Fastener SystemOsteoCentric Technologies20221—
+7K221244CD Horizon™ Spinal SystemMedtronic202220—
+7K213491Universal Pilot Guidance Instrument SystemCtl Medical Corporation20220—
+7K212489BonOs Inject Bone Cement; NEO Pedicle Screw SystemNeo Medical SA20215—
+7K211474Kleiner KG2 SystemBAAT Medical Products B.V.20210—
+7K203023Pisces Spinal SystemOrtho Development Corporation20210—
+7K210061ProLift Lateral HELO FixatedLife Spine, Inc.20213—
+7K210716CarboClear X Pedicle Screw System, CarboClear X Navigated InstrumentsCarboFix Orthopedics, Ltd.20218—
+7K203673MySpine Pedicle Screw Placement Guides Extension (MySpine Low Profile Guides, MySpine MC…Medacta International S.A.20213—
+7K202398Ti3Z Cervical Interbody SystemZavation Medical Products, LLC20219—
+7K203452Nano FortiFix® SystemNanovis, LLC20200—
+7K203317CarboClear X Pedicle Screw SystemCarboFix Orthopedics, Ltd.20209—
+7K202305Zavation IBF SystemZavation Medical Products, LLC20209—
+7K200792MySpine S2-Alar/Alar-Iliac Pedicle Screw Placement GuidesMedacta Inernational SA20204—
+7K201006K2M Navigation InstrumentsK2m, Inc.20200—
+7K201251CarboClear Navigated InstrumentsCarboFix Orthopedics, Ltd.20209—
+7K200519CarboClear® II Pedicle Screw SystemCarboFix Orthopedics, Ltd.202011—
+7K193270CapLOX II®/TowerLOX® MIS Pedicle Screw SystemCaptiva Spine, Inc.20200—
+7K182987Genesys Spine 3DP Lumbar Interbody SystemGenesys Spine20199—
+7K191722Vital Navigation SystemZimmer Biomet Spine, Inc.20192—
+7K192281AEGIS Anterior Lumbar Plate System, ALC Dynamized Fixation System, Anterior ISOLA Spine…Medos International SARL20190—
+7K191854Premia Spine XL InstrumentsPremia Spine, Ltd.20190—
+7K190163ALARA Neuro Access KitSurGenTec, LLC20192—
+7K182416NOVA Minimally Invasive SystemBaui Biotech Co., Ltd.20192—
+7K182617ATEC IOM Accessory InstrumentsAlphatec Spine, Inc.20193—
+7K182771ISS-JAZZ Screw System and JAZZ CAP SPImplanet, S.A.20195—
+7K182377CarboClear® Pedicle Screw SystemCarboFix Orthopedics, Ltd.201839—
+7K181821MOSS VRS Spinal SystemBiedermann Motech GmbH & Co. KG20181—
+7K180179Firebird® Spinal Fixation Systems: Firebird System; Firebird Deformity System; Firebird®…Orthofix, Inc.201837—
+7K181281Altus Spine Pedicle Screw SystemAltus Partners, LLC20181—
+7K180475CapLOX II® / TowerLOX® MIS Pedicle Screw SystemCaptiva Spine, Inc.20180—
+7K180153X-spine Cortical Bone Screw SystemX-Spine Systems, Inc.20180—
+7K171421VERTICALE® Posterior Spinal Fixation System/VERTICALE® SystemSilony Medical GmbH20186—
+7K172417SILC® Fixation SystemGlobus Medical, Inc.20171—
+7K172194Connector SystemOrthofix, Inc.2017162
+7K161225Paonan Armstrong Posterior Spinal Fixation SystemPaonan Biotech Co., Ltd.20172—
+7K162921Navigated Instrument SystemOrthofix, Inc.20175—
+7K162419FIREFLY® Pedicle Screw Navigation GuideMighty Oak Medical, Inc.20167—
+7K161014NuVasive® Reline® SystemNu Vasive, Incorporated201648—
+7K161387Mont Blanc and Mont Blanc MIS Spinal SystemsSpineway SA20163—
+7K160226JAZZ CLAW System (hooks and rods) and JAZZ CLAW connectorImplanet, S.A.20161—
+7K153404Zavation Spinal SystemZavation, LLC20161—
+7K151116CapLOX II/TowerLOX Pedicle Screw SystemCaptiva Spine20153—
+7K141850Flospine Pedicle Screw SystemFlospine20140—
+7K140457Nautilus Spinal SystemLife Spine, Inc.20143—
+8K261020Symmetrix™ L Spinal SystemMedtronic Sofamor Danek USA, Inc.20260—
+8K253045“Socko” Vimax Spinal Fixation SystemSocko Medical Co., Ltd.20260—
+8K251251ChanPin Pedicle Screw Spinal SystemChanpin Medtak Co., Ltd.20260—
+8K260385aprevo® anterior and lateral lumbar interbody system; aprevo® posterior and…Carlsmed, Inc.20260—
+8K260216CD Horizon™ ModuLeX™ Fenestrated Screw Set; CD Horizon™ ModuLeX™ Spinal SystemMedtronic Sofamor Danek USA, Inc.20260—
+8K252240Spectrum Spine Cervical Cage System; Spectrum Spine Lumbar Cage SystemSpectrum Spine20260—
+8K253583LUX Expandable Lumbar Interbody SystemXenix Medical20260—
+8K253488iFuse INTRA Ti™ Implant SystemSI-BONE, Inc.20260—
+8K253941CD Horizon™ ModuLeX™ Spinal System (LigaMAS Head Assembly)Medtronic Sofamor Danek USA, Inc.20260—
+8K251829DeGen Medical Patient Specific Implant (PSI) SystemDegen Medical20250—
+8K250520OsteoCentric Navigated Instruments SystemOsteocentric Technologies, Inc.20250—
+8K253335CD Horizon™ Spinal SystemMedtronic Sofamor Danek USA, Inc.20250—