510(k) Report

Devices descending from K073291

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

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+3K230708Peridot-TD Spacer system (The Peridot-TD Intervertebral body fusion system); Anterior…Gbs Commonwealth Co., Ltd.20233—
+3K223611Calibrate LTX Interbody SystemAlphatec Spine, Inc.20237—
+3K223418DeGen Impulse AM™ SystemDegen Medical20236—
+3K222554EL CAPITAN Anterior Lumbar Interbody FusionAstura Medical20235—
+3K221182Southern Transforaminal Lumbar Interbody Fusion (TLIF)Southern Medical (Pty), Ltd.20220—
+3K221806TruLift Lateral Expandable Spacer System & Lateral Plate SystemLife Spine, Inc.20221—
+3K221545MectaLIF Anterior ExtensionMedacta International S.A.202226
+3K221858ZSFab Lumbar Interbody SystemZsfab, Inc.20224—
+3K221172FOCUS Interbody SystemOc Medical Devices20220—
+3K222383Anteralign™ LS Spinal System with Titan nanoLOCK™ Surface Technology MAZORX Stealth (TM)…Medtronic Sofamor Danek USA, Inc.20220—
+3K220523restor3d TiDAL Lumbar Interbody Fusion DeviceRestor3D20222—
+3K220711SeaSpine Meridian System, SeaSpine Meridian Anterior Plate SystemSeaSpine Orthopedics Corporation202210—
+3K213355Toro-L Interbody Fusion SystemIntegrity Implants, Inc.20224—
+3K213980Peridot Spinal Interbody SystemGbs Commonwealth Co., Ltd.20224—
+3K213441PathLoc Lumbar Interbody Fusion Cage SystemL&K BIOMED Co., Ltd.20222—
+3K220096Genesys Spine 3DP Lumbar Interbody SystemGenesys Spine20220—
+3K212075ShurFit Lumbar Interbody SystemPrecision Spine, Inc.20211—
+3K212653Catalyft LS Expandable Interbody SystemMedtronic Sofamor Danek USA, Inc.202127
+3K212389Advantage Lumbar System - ALIF, PLIF, DLIF, TLIFIntelivation, LLC20210—
+3K211769OneLIF Intervertebral Body Replacement SystemNovapproach Spine202112
+3K212070KMTI S141 Lumbar Interbody Fusion SystemKyocera Medical Technologies, Inc.20210—
+3K211873PSX Interbody SystemAlphatec Spine, Inc.202111—
+3K211441Navigated Anterolateral Disc Prep InstrumentsMedtronic Sofamor Danek USA, Inc.20219—
+3K210583SeaSpine WaveForm™ A Interbody SystemSeaSpine Orthopedics Corporation202114—
+3K210214NuVasive Modulus Expandable Posterior Lumbar MOD-EX PL Interbody SystemNu Vasive, Incorporated20213—
+3K203520Blustone Synergy Interbody Fusion SystemBlustone Synergy, LLC20210—
+3K202032Idys LLIF 3DTiClariance, Sas20210—
+3K202872Prase PEEK Anterior Cervical Interbody SpacerGbs Commonwealth Co., Ltd.20215—
+3K202495SIRION Lateral Lumbar Interbody FusionAstura Medical, LLC20216—
+3K203561ChoiceSpine Navigation SystemChoice Spine, LLC20211—
+3K202820Australis Anterior Lumbar Cage SystemPrism Surgical Designs Pty, Ltd.20200—
+3K192863MONDRIAN Lumbar Interbody Fusion Cage SystemCtl Medical Corporation20203—
+3K200991EVOL Spinal Interbody SystemCutting Edge Spine, LLC20200—
+3K193457AUDERE Lumbar Spacer SystemMet One Technologies20201—
+3K192492EL CAPITAN Anterior Lumber Interbody SystemAstura Medical, LLC202010—
+3K200312Tryptik TiSpineart20202—
+3K192006SIRION Lateral Lumbar Interbody SystemAstura Medical, LLC202014—
+3K193541NuVasive Cohere Thoracolumbar Interbody SystemNu Vasive, Incorporated2020157—
+3K200048MectaLIF Anterior SimpleMedacta International S.A.20200—
+3K192906Mecta-C Stand AloneMedacta International S.A.20201—
+3K191489Genesys Spine 3DP Cervical Interbody SystemGenesys Spine20207—
+3K192497EVOL ha - D Lateral Interbody Fusion SystemCutting Edge Spine, LLC20201—
+3K193174Keos Lumbar IBFDKeos20190—
+3K192248Cortina™ [MAX] Lumbar Cage SystemNeurostructures, Inc.20190—
+3K192336Navigated Anterolateral Disc Prep InstrumentsMedtronic Sofamor Danek USA, Inc.201917—
+3K191134IB3D AlifMedicrea International SA20191—
+3K191066CD Horizon™ Astute™ Spinal SystemMedtronic Sofamor Danek USA, Inc.201921—
+3K190708AccelFix Lumbar Interbody Fusion Cage SystemL&K BIOMED Co., Ltd.20195—
+3K183407Triton CageMedyssey USA, Inc.20190—
+3K192018Endoskeleton TA Interbody Fusion Device, Endoskeleton TAS and TAS Hyperlordotic…Titan Spine, Inc.20191024
+3K191100ExcelsiusGPS Spine 1.1 Interbody ModuleGlobus Medical, Inc.201942—
+3K182158UNiD Patient-matched PLIF cageMedicrea International SA201921—
+3K183243Velofix TLIF CageU&I Corporation20190—
+3K190092UNiD Patient specific 3D printed TLIF cageMedicrea International SA201913—
+3K182877HALF DOME Posterior Lumbar Interbody SystemAstura Medical, LLC201921—
+3K183259Idys™ TLIF TiVacClariance, Sas20191—
+3K180230NEST Interbody SystemPaonan Biotech Co., Ltd.20191—
+3K181096Avenue P Cage SystemZimmer Biomet Spine, Inc.20190—
+3K182721Choice Spine Navigation SystemChoicespine, LP20192—
+3K183239CoreLink F3D™ Lateral SystemCorelink, LLC20188—
+3K181357PATRIOT® Lumbar Spacers, SUSTAIN® SpacersGlobus Medical, Inc.201897—
+3K181818Scarlet AL-TSpineart201864—
+3K181860NuVasive Cohere Thoracolumbar Interbody SystemNu Vasive, Incorporated2018159—
+3K180814CoreLink® M3™ Stand-Alone Anterior Lumbar SystemCorelink, LLC201818—
+3K180556Corelink Foundation 3D Anterior Lumbar SystemCorelink, LLC20185—
+3K181203Juliet TiSpineart20181—
+3K173347STALIF C FLX, STALIF M FLX, STALIF L FLX and STALIF Lateral-Oblique FLX, ACTILIF C FLX…Centinel Spine, Inc.201812—
+3K173782UNiD Patient Specific 3D printed cageMedicrea International SA201823—
+3K180002Rampart One Lumbar Interbody Fusion DeviceSpineology, Inc.20182—
+3K180431Cortina [MAX] Lumbar Cage SystemNeurostructures, Inc.20181—
+3K172816TiGer Shark™ SystemChoicespine, LP201859—
+3K173702Juliet Ti LLSpineart20182—
+3K171848FORTIFY and FORTIFY Integrated Corpectomy Spacers, XPand Corpectomy Spacers, NIKO…Globus Medical, Inc.201755—
+3K173182ProLift® Expandable SystemLife Spine, Inc.201737—
+3K172465Idys™ TLIF 3DTi CagesClariance, Sas20176—
+3K170389TAURUS PEEK Cage SystemMedyssey USA, Inc.20170—
+3K172009Cascadia Interbody SystemK2m, Inc.2017433
+3K172419Velofix™ TLIF CageU&I Corporation20172—
+3K172083Idys™ ALIF SystemClariance, Sas20177—
+3K172392Lateral Spinal Truss System (LSTS) Interbody Fusion Device4Web, Inc.20171—
+3K172341NuVasive® Modulus TLIF Interbody SystemNu Vasive, Incorporated2017163—
+3K171633NuVasive TLX Interbody SystemNu Vasive, Incorporated2017251—
+3K172587Mecta-C with titanium markers and Mecta-C TiPEEK with titanium markersMedacta International S.A.20170—
+3K170851Anterior Spine Truss System (STS) Interbody Fusion Device4Web, Inc.20175—
+3K171630LumFuse-TPPrecifit Medical, Ltd.20171—
+3K171749Velofix (tm) Interbody Fusion SystemU&I Corporation20175—
+3K170318NeoFuse Ti3D PLIF/TLIF/Cervical InterbodyHt Medical, LLC201749—
+3K163506Coalesce™ (-Straight, -Convex, -Crescent, -Lateral, -Anterior, or -Oblique) Lumbar…Vertera, Inc.2017224—
+3K162212Divergence-L Anterior/Oblique Lumbar Fusion SystemMedtronic Sofamor Danek USA, Inc.201757—
+3K163230NuVasive Modulus XLIF Interbody SystemNu Vasive, Incorporated2017276—
+3K162680SOVEREIGN® Spinal SystemMedtronic Sofamor Danek USA, Inc.201631—
+3K162327COUGAR® LS Lateral Cage System and COUGAR® SystemMedos International SARL2016111—
+3K162103Choice Spine Lumbar Spacer System (Sabre™, Shark™, Hornet™, Harpoon™), Choice Spine…Choicespine, LP2016161—
+3K160074Rampart D Lumbar Interbody Fusion DeviceSpineology, Inc.20165—
+3K161379ELSA SpacersGlobus Medical, Inc.2016155—
+3K161173Avenue® T TLIF CageLdr Spine USA, Inc.20163—
+3K161210RIALTO (TM) SI Fusion System, Medtronic Reusable Instruments for Use with the IPC (TM)…Medtronic Sofamor Danek201679—
+3K160605MectaLIF Anterior Stand-AloneMedacta International201610—
+3K161223TransContinental® M Spacers and InterContinental® Plate-SpacersGlobus Medical, Inc.2016117—
+3K153786Prow Fusion-VNlt Spine, Ltd.20166—