510(k) Report

Devices descending from K123027

709 later devices reach Capstone (R) Spinal System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+3K211689KEYSTONE PEEK Cage SystemShanghai Sanyou Medical Co, Ltd.20212—
+3K211769OneLIF Intervertebral Body Replacement SystemNovapproach Spine202112
+3K210044Crystal Spinal System & Vertu Spinal System, Lucent Spinal System, Zeus Spinal System…Spinal Elements, Inc.20211—
+3K210583SeaSpine WaveForm™ A Interbody SystemSeaSpine Orthopedics Corporation202114—
+3K210439NuVasive MOD-EX XLIF Interbody SystemNu Vasive, Incorporated20214—
+3K201671A-Link ZAcuity Surgical Devices, LLC202125—
+3K203201NuVasive Thoracolumbar Interbody Systems: CoRoent Thoracolumbar System, CoRoent XL…Nu Vasive, Incorporated202194—
+3K201820NuVasive Thoracolumbar Interbody Systems: CoRoent Thoracolumbar System, CoRoent XL…Nu Vasive, Incorporated2020156—
+3K201585Monterey AL Interbody SystemStryker Corporation202044
+3K200312Tryptik TiSpineart20202—
+3K193593NuVasive 3DP Interfixated ALIF SystemNu Vasive, Incorporated2020157—
+3K191796Neo Cage SystemNeo Medical SA20190—
+3K192026Peridot Intervertebral body fusion SystemGbs Commonwealth Co., Ltd.20196—
+3K192760NuVasive Modulus XLIF Interbody SystemNu Vasive, Incorporated2019163—
+3K192214CarboClear VBR SystemCarboFix Orthopedics, Ltd.20191—
+3K191066CD Horizon™ Astute™ Spinal SystemMedtronic Sofamor Danek USA, Inc.201921—
+3K191039Navigated T2 STRATOSPHERE Inserters and Navigated TemplatesMedtronic Sofamor Danek USA, Inc.201918—
+3K192018Endoskeleton TA Interbody Fusion Device, Endoskeleton TAS and TAS Hyperlordotic…Titan Spine, Inc.20191024
+3K183249Tritanium X PL Expandable Posterior Lumbar Cage, Tritanium X TL Expandable Curved…Stryker Spine20196—
+3K191100ExcelsiusGPS Spine 1.1 Interbody ModuleGlobus Medical, Inc.201942—
+3K190165Capstone Control™ Spinal SystemMedtronic Sofamor Danek USA, Inc.20196—
+3K181048Neo Cage System TMNeo Medical SA20191—
+3K180230NEST Interbody SystemPaonan Biotech Co., Ltd.20191—
+3K182284Tyber Medical PT Interbody SpacerTyber Medical, LLC20195—
+3K182584Lucent® XPSpinal Elements, Inc.20183—
+3K181837Spinal Elements Ti-Bond coated devicesSpinal Elements, Inc.201898—
+3K181818Scarlet AL-TSpineart201864—
+3K181397DualXInnovasive, Inc.201815—
+3K181386NuVasive Brigade Lateral SystemNu Vasive, Incorporated2018158—
+3K180076Ti 3Z Interbody SystemZavation Medical Products, LLC20184—
+3K181203Juliet TiSpineart20181—
+3K173892NuVasive® XLX Interbody SystemNu Vasive, Incorporated2018115—
+3K173082Arco™-SA Lumbar Cage SystemNeurostructures, Inc.20185—
+3K173702Juliet Ti LLSpineart20182—
+3K172419Velofix™ TLIF CageU&I Corporation20172—
+3K172083Idys™ ALIF SystemClariance, Sas20177—
+3K172123NuVasive® Modulus XLIF Interbody SystemNu Vasive, Incorporated2017227—
+3K171633NuVasive TLX Interbody SystemNu Vasive, Incorporated2017251—
+3K163422Shanghai Sanyou PEEK Cage SystemShanghai Sanyou Medical Co, Ltd.20173—
+3K171496Tritanium C Anterior Cervical CageStryker Spine2017129—
+3K170851Anterior Spine Truss System (STS) Interbody Fusion Device4Web, Inc.20175—
+3K171630LumFuse-TPPrecifit Medical, Ltd.20171—
+3K170962NuVasive® CoRoent® Thoracolumbar SystemNu Vasive, Incorporated2017304—
+3K163707NuVasive CoRoent Ti-C SystemNu Vasive, Incorporated201719—
+3K170592NuVasive BASE Interfixated Titanium SystemNu Vasive, Incorporated2017186—
+3K163230NuVasive Modulus XLIF Interbody SystemNu Vasive, Incorporated2017276—
+3K162680SOVEREIGN® Spinal SystemMedtronic Sofamor Danek USA, Inc.201631—
+3K160959Xsert Lumbar Expandable Interbody SystemX-Spine Systems, Inc.201612—
+3K162262Tritanium® PL CageStryker2016132—
+3K161379ELSA SpacersGlobus Medical, Inc.2016155—
+3K161173Avenue® T TLIF CageLdr Spine USA, Inc.20163—
+3K160955Tritanium® PL CageStryker2016178—
+3K160715AccuLIF TL and PL CageStryker Corporation20160—
+3K160125Cascadia Interbody SystemK2m2016315—
+3K153419NuVasive CoRoent Thoracolumbar SystemNu Vasive, Incorporated2016400—
+3K153495Avenue L Lateral Lumbar Cage, Avenue T TLIF Cage System, ROI-A ALIF Cage System, ROI-T…Ldr Spine USA20161891
+3K151310Amendia Interbody Fusion DevicesAmendia, Inc.2016169—
+3K143479Bluefin Interbody SystemTides Medical20152—
+4K262067iFuse Granite Onyx™ Implant SystemSI-BONE, Inc.20260—
+4K261809Interwedge® Standalone LateralFoundation Surgical Group20260—
+4K262061Tritanium® C Anterior Cervical Cage; Tritanium® PL Cage; Tritanium® TL Curved Posterior…Stryker Spine20260—
+4K261284Invictus® Small Stature Spinal Fixation System; Invictus® 2.0 Spinal Fixation SystemAlphatec Spine, Inc.20260—
+4K253420Admiral ACP System; Explorer TO System; Laminoplasty System; Manta Ray TDF Spacer…SeaSpine Orthopedics Corporation20260—
+4K261665CORUS™ Navigation System-GNProvidence Medical Technology, Inc.20260—
+4K261060Navigated LLIF Impactable TrackerTyber Medical, LLC20260—
+4K253401SCRIPT™ Implant SystemGlobus Medical, Inc.20260—
+4K254274ARx® SAI Implant SystemLife Spine, Inc.20260—
+4K254017SWINGO-3D Lumbar Cage SystemImplanet20260—
+4K252610ZSFab Lumbar Interbody SystemZsfab, Inc.20251—
+4K250599ExcelsiusGPS™ InstrumentsGlobus Medical, Inc.20250—
+4K252322SIros-X SystemGenesys Spine20250—
+4K253094iFuse Bedrock Granite Implant SystemSI-BONE, Inc.20250—
+4K251575IdentiTi™ II ALIF Standalone Interbody System; Transcend™ ALIF Standalone Interbody SystemAlphatec Spine20250—
+4K252113PRADO™ Lumbar Interbody Fusion SystemBethesda Medical Devices20250—
+4K251060CORUS™ Navigation System-GXProvidence Medical Technology, Inc.20250—
+4K250072CONDUIT™ SYNFIX™ Evolution Secured Spacer SystemAvalign Technologies, Inc.20251—
+4K241525ExcelsiusXR™Globus Medical, Inc.20250—
+4K251080IdentiTi II Cervical Interbody SystemAlphatec Spine, Inc.20250—
+4K251617X-PAC® TLIF Expandable Posterior Cage System; X-PAC® LLIF Expandable Lateral Cage SystemExpanding Innovations, Inc.20250—
+4K251459OneLIF™ Interbody Fusion SystemNovapproach Spine, LLC20250—
+4K243386Ventris Intervertebral Body Fusion DeviceAcuity Surgical Devices, LLC20252—
+4K243802aprevo® anterior and lateral lumbar interbody fusion device, aprevo® anterior lumbar…Carlsmed, Inc.20253—
+4K250605EVOL® ha – Hyper C Cervical Interbody Fusion SystemCutting Edge Spine, LLC20250—
+4K243461Calibrate Interbody SystemsAlphatec Spine, Inc.20250—
+4K243814NuVasive Pulse SystemGlobus Medical, Inc.20250—
+4K242517ProAM ACDF SystemPro Surgical, Inc.20240—
+4K242734ZSFab Cervical Interbody System; ZSFab Lumbar Interbody SystemZsfab20243—
+4K242589Scarlet® AL-TSpineart SA20240—
+4K243007CD Horizon™ Spinal SystemMedtronic Sofamor Danek USA, Inc.20243—
+4K242826ProLift Wedge Expandable Spacer SystemLife Spine, Inc.20240—
+4K234035COSINE™ SpacerGlobus Medical, Inc.20240—
+4K241846E3D™-C Interbody SystemEvolution Spine20246—
+4K241464ARx® SAI Implant SystemLife Spine, Inc.20241—
+4K241321Juliet® Ti LL Lumbar Interbody DeviceSpineart SA20240—
+4K240830Reef TO/TA System; Regatta Lateral System; Explorer TO System; WaveForm C Interbody…Orthofix Medical, Inc.20242—
+4K241466Shoreline ACS Interbody System; Shoreline RT Interbody System; Regatta Lateral System…SeaSpine Orthopedics Corporation20243—
+4K233228Spine Navigation and Robotic-Assistance DeviceEcential Robotics202421
+4K241396uCerv Flux™-C 3D Porous Titanium Cervical InterbodyUlrich Medical USA, Inc.20240—
+4K240699SCARLET® AC-TiSpineart SA20240—
+4K240126ProAM ALIF SystemPro Surgical, Inc.20242—