510(k) Report

Devices descending from K073291

1,103 later devices reach Capstone Spinal System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+4K230478Acro Composites Interbody SystemAcro Composites, LLC20230—
+4K232123MectaLIF Anterior Lag ExtensionMedacta International S.A.20231—
+4K232822Peridot-TD Spacer system (The Peridot-TD Intervertebral body fusion system), Anterior…Gbs Commonwealth Co., Ltd.20232—
+4K222988neoWave LS Lumbar Straight, neoWave C Cervical, and Ti3D CervicalHt Medical D.B.A. Xenix Medical20232—
+4K231680AccelFix Lumbar Expandable Cage SystemL&K BIOMED Co., Ltd.20231—
+4K232116CoreLink Navigation InstrumentsCorelink, LLC20230—
+4K231829Xenix Medical Sacroiliac Fixation SystemHt Medical D.B.A. Xenix Medical20232—
+4K223301ASTRA & AVANT Navigation Instruments System and ASTRA-OCT Navigation Instruments SystemSpinecraft, LLC20230—
+4K230329F3D Interbody SystemCorelink, LLC20230—
+4K223335SIRION Lateral Lumbar Interbody SystemAstura Medical20230—
+4K220513NITRO Interbody Fusion Cage System FamilyCtl Medical Corporation20230—
+4K220261NEST-C Interbody SystemPaonan Biotech Co., Ltd.20230—
+4K223326Axiom PSR SystemRestor3D202301
+4K223765ATEC Lateral Navigation InstrumentsAlphatec Spine, Inc.202302
+4K230583Tryptik TiSpineart SA20231—
+4K223731NuVasive Modulus-C Interbody SystemNuvasive, Inc.202311—
+4K223200Curiteva Navigation SystemCuriteva, Inc.20230—
+4K222806Kodiak C Spinal Implant SystemMet One Technologies, LLC20221—
+4K222455Calibrate LTX Interbody SystemAlphatec Spine, Inc.20228—
+4K222732WaveForm A Interbody SystemSeaSpine Orthopedics Corporation20229—
+4K222270HEDRON Cervical Spacers, HEDRON Lumbar Spacers, SABLE Expandable Spacer, ExcelsiusGPS…Globus Medical, Inc.202223—
+4K222203DualXSLIM (R) T/PLIFAmplify Surgical, Inc.20223—
+4K221447Southern Anterior Screw Fixated Cage (SASCA)Southern Medical (Pty), Ltd.20220—
+4K221646CD HORIZON™ ASTUTE™ SPINAL SYSTEM; CD HORIZON™ Growth Rod Conversion Set; CD HORIZON™…Medtronic Sofamor Danek USA, Inc.202220—
+4K221047SILO TFX MIS Sacroiliac Joint Fixation SystemAurora Spine, Inc.20229—
+4K213641MONDRIAN ALIF Cage with Supplementary Fixation PlateCtl Medical Corporation20221—
+4K220953ChoiceSpine TigerShark™ M, Modular Interbody SystemChoice Spine, LLC20220—
+4K220024ChoiceSpine Navigation SystemChoice Spine, LLC20220—
+4K220478NuVasive MOD-EX XLIF Interbody System, NuVasive MOD-EX XLIF Plated 2.0 Interbody SystemNu Vasive, Incorporated20222—
+4K220973CoreLink Navigation InstrumentsCorelink, LLC20221—
+4K221244CD Horizon™ Spinal SystemMedtronic202220—
+4K213491Universal Pilot Guidance Instrument SystemCtl Medical Corporation20220—
+4K213935PISCES-SA Standalone ALIF Interbody SystemOsseus Fusion Systems202212—
+4K220038Camber Spine Navigation SystemCamber Spine Technologies20220—
+4K213118Dakota ALIF SystemPrecision Spine, Inc.20220—
+4K214047EL CAPITAN Anterior Lumbar Interbody Fusion SystemAstura Medical20223—
+4K211417F3D-C2 Cervical Stand-Alone SystemCorelink, LLC20223—
+4K212903SIMPACT Sacroiliac Joint Fixation SystemLife Spine, Inc.20218—
+4K211845Deploy Expandable Interbody SystemSouthern Spine, LLC20210—
+4K212825CoreLink Navigation InstrumentsCorelink, LLC20214—
+4K212520ProLift Micro Expandable Spacer SystemLife Spine, Inc.20216—
+4K212028Dark Star Navigation Instrument SystemRepublic Spine, LLC20210—
+4K201793EDEN Peek CageJmt Co., Ltd.20210—
+4K210470C-CURVE Interbody Fusion DeviceMedicrea International SA20210—
+4K211616ExcelsiusHubGlobus Medical, Inc.20219Class I
+4K212007VERTICALE Navigation InstrumentsSilony Medical GmbH20214—
+4K211388Lateral Spine Truss System (LSTS) Interbody Fusion Device4Web Medical, Inc.20210—
+4K210044Crystal Spinal System & Vertu Spinal System, Lucent Spinal System, Zeus Spinal System…Spinal Elements, Inc.20211—
+4K210542aprevo Transforaminal IBFCarlsmed, Inc.202112—
+4K211258Endoskeleton TC Interbody System, Endoskeleton TCS Interbody System, Endoskeleton TA…Medtronic Sofamor Danek USA, Inc.202175—
+4K210439NuVasive MOD-EX XLIF Interbody SystemNu Vasive, Incorporated20214—
+4K201671A-Link ZAcuity Surgical Devices, LLC202125—
+4K210061ProLift Lateral HELO FixatedLife Spine, Inc.20213—
+4K200919Idys ALIF 3DTiClariance20210—
+4K203742IdentiTi ALIF Standalone Interbody SystemAlphatec Spine, Inc.202159—
+4K210716CarboClear X Pedicle Screw System, CarboClear X Navigated InstrumentsCarboFix Orthopedics, Ltd.20218—
+4K203780Harvester SI: Sacroiliac Fixation SystemSpinus International, Inc.20210—
+4K203361ProLift Wedge Expandable Spacer SystemLife Spine, Inc.20211—
+4K203573RESPONSE Navigation InstrumentsOrthoPediatrics Corp.20210—
+4K203278INDEPENDENCE Spacers, HEDRON IA, MAGNIFY-S Spacers, MONUMENT Spacers, InterContinental…Globus Medical, Inc.202135—
+4K203531XYPAN Expandable Lumbar Cage SystemAegis Spine, Inc.20213—
+4K203683CarboClear Lumbar Cage SystemCarbofix Orthpedics, Ltd.20211—
+4K203201NuVasive Thoracolumbar Interbody Systems: CoRoent Thoracolumbar System, CoRoent XL…Nu Vasive, Incorporated202194—
+4K200458Tailored-C Cervical Interbody Fusion SystemBespoke Technologies20203—
+4K201755WaveForm L Interbody System, WaveForm TO Interbody System, WaveForm TA Interbody SystemSeaSpine Orthopedics Corporation202017—
+4K202034aprevo Intervertebral Body Fusion DeviceCarlsmed, Inc.202017—
+4K200719NuVasive Navigation.S InstrumentsNu Vasive, Incorporated20204—
+4K203076Mecta-C Stand Alone ExtensionMedacta International S.A.20200—
+4K200316UNiD IB3D ALIFMedicrea International SA20200—
+4K201692NuVasive Modulus XLIF Interbody SystemNu Vasive, Incorporated202067—
+4K201939GAIA Lumbar Interbody Fusion Device (LIFD) FamilyPrinterprezz20200—
+4K201453Fortilink Cages with TiPlus TechnologyParadigm Spine GmbH20204—
+4K200953NuVasive® Cohere® Thoracolumbar Interbody SystemNu Vasive, Incorporated2020141—
+4K202190Oculus-SA Lumbar Cage SystemNeurostructures20200—
+4K201820NuVasive Thoracolumbar Interbody Systems: CoRoent Thoracolumbar System, CoRoent XL…Nu Vasive, Incorporated2020156—
+4K201506Talos®-C Cervical Intervertebral Body Fusion System, Talos®-C (HA) Cervical…Meditech Spine, LLC20200—
+4K201721TruLift Expandable Spacer SystemLife Spine, Inc.20205—
+4K201585Monterey AL Interbody SystemStryker Corporation202044
+4K201251CarboClear Navigated InstrumentsCarboFix Orthopedics, Ltd.20209—
+4K190580NADIA SI Fusion SystemIlion Medical, Inc.20203—
+4K200047ExcelsiusGPS Cranial 1.0 ModuleGlobus Medical, Inc.202053
+4K200920Idys ALIF ZP 3DTiClariance, Sas20203—
+4K200541Hive™ Stand-alone Anterior Lumbar Interbody SystemHd Lifesciences, LLC20201—
+4K200338ProLift Lateral FixatedLife Spine, Inc.20205—
+4K193593NuVasive 3DP Interfixated ALIF SystemNu Vasive, Incorporated2020157—
+4K193418SeaSpine Skipjack SystemSeaSpine Orthopedics Corporation20204—
+4K193378CarboClear Lumbar Cage SystemCarboFix Orthopedics, Ltd.20202—
+4K192993Scarlet AL-TSpineart20201—
+4K193370Nexxt Matrixx SystemNexxt Spine, LLC20202—
+4K192115SABLE Expandable SpacerGlobus Medical, Inc.202037—
+4K191581Endoskeleton TL Interbody Fusion Device, Endoskeleton TL Hyperlordotic Interbody Fusion…Titan Spine, Inc.202081—
+4K182731Corelink Navigation InstrumentsCorelink, LLC20195—
+4K192168Idys ALIF ZP 3DTiClariance, Sas20195—
+4K192760NuVasive Modulus XLIF Interbody SystemNu Vasive, Incorporated2019163—
+4K191854Premia Spine XL InstrumentsPremia Spine, Ltd.20190—
+4K191748Genesys Spine Sacroiliac Joint Fusion SystemGenesys Spine201922—
+4K191391HEDRON Lumbar SpacersGlobus Medical, Inc.201984—
+4K192054Endoskeleton TAS PlateTitan Spine, Inc.20190—
+4K183249Tritanium X PL Expandable Posterior Lumbar Cage, Tritanium X TL Expandable Curved…Stryker Spine20196—
+4K190488ProLift Expandable SystemLife Spine, Inc.201916—