510(k) Report

Devices descending from K082342

716 later devices reach Modification to Capstone Spinal System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+5K222874CarboClear Cervical Cage System, CarboClear Cervical VBR SystemCarbofix Orthpedics, Ltd.20230—
+5K231438Calibrate PSX Interbody System, Calibrate NanoTec PSX Interbody SystemAlphatec Spine, Inc.20237—
+5K231252Ventana™ L Spinal SystemSpinal Elements, Inc.20231—
+5K230936Anatomic PEEK™ Cervical Fusion System with NanotechnologyNanovis, LLC20230—
+5K223611Calibrate LTX Interbody SystemAlphatec Spine, Inc.20237—
+5K223688CONDUIT™ Lateral Lumbar Intervertebral Fusion Cage, CONDUIT™ InstrumentsMedos International Sàrl20230—
+5K221490Tritanium C Anterior Cervical Cage, Tritanium PL Cage, Tritanium TL Curved Posterior…Stryker Spine20231—
+5K2136534CIS Black Marlin Plif Cage System, 4CIS Dolphin Tlif Cage SystemSolco Biomedical Company India Private Limited20220—
+5K221858ZSFab Lumbar Interbody SystemZsfab, Inc.20224—
+5K221172FOCUS Interbody SystemOc Medical Devices20220—
+5K222383Anteralign™ LS Spinal System with Titan nanoLOCK™ Surface Technology MAZORX Stealth (TM)…Medtronic Sofamor Danek USA, Inc.20220—
+5K220478NuVasive MOD-EX XLIF Interbody System, NuVasive MOD-EX XLIF Plated 2.0 Interbody SystemNu Vasive, Incorporated20222—
+5K220711SeaSpine Meridian System, SeaSpine Meridian Anterior Plate SystemSeaSpine Orthopedics Corporation202210—
+5K212498Stable-L Standalone Lumbar Interbody SystemNexus Spine, LLC20227—
+5K212653Catalyft LS Expandable Interbody SystemMedtronic Sofamor Danek USA, Inc.202127
+5K211689KEYSTONE PEEK Cage SystemShanghai Sanyou Medical Co, Ltd.20212—
+5K211769OneLIF Intervertebral Body Replacement SystemNovapproach Spine202112
+5K210044Crystal Spinal System & Vertu Spinal System, Lucent Spinal System, Zeus Spinal System…Spinal Elements, Inc.20211—
+5K210583SeaSpine WaveForm™ A Interbody SystemSeaSpine Orthopedics Corporation202114—
+5K210439NuVasive MOD-EX XLIF Interbody SystemNu Vasive, Incorporated20214—
+5K201671A-Link ZAcuity Surgical Devices, LLC202125—
+5K203201NuVasive Thoracolumbar Interbody Systems: CoRoent Thoracolumbar System, CoRoent XL…Nu Vasive, Incorporated202194—
+5K201820NuVasive Thoracolumbar Interbody Systems: CoRoent Thoracolumbar System, CoRoent XL…Nu Vasive, Incorporated2020156—
+5K201585Monterey AL Interbody SystemStryker Corporation202044
+5K200312Tryptik TiSpineart20202—
+5K193593NuVasive 3DP Interfixated ALIF SystemNu Vasive, Incorporated2020157—
+5K192026Peridot Intervertebral body fusion SystemGbs Commonwealth Co., Ltd.20196—
+5K192760NuVasive Modulus XLIF Interbody SystemNu Vasive, Incorporated2019163—
+5K192214CarboClear VBR SystemCarboFix Orthopedics, Ltd.20191—
+5K191066CD Horizon™ Astute™ Spinal SystemMedtronic Sofamor Danek USA, Inc.201921—
+5K191039Navigated T2 STRATOSPHERE Inserters and Navigated TemplatesMedtronic Sofamor Danek USA, Inc.201918—
+5K192018Endoskeleton TA Interbody Fusion Device, Endoskeleton TAS and TAS Hyperlordotic…Titan Spine, Inc.20191024
+5K183249Tritanium X PL Expandable Posterior Lumbar Cage, Tritanium X TL Expandable Curved…Stryker Spine20196—
+5K191100ExcelsiusGPS Spine 1.1 Interbody ModuleGlobus Medical, Inc.201942—
+5K190165Capstone Control™ Spinal SystemMedtronic Sofamor Danek USA, Inc.20196—
+5K180230NEST Interbody SystemPaonan Biotech Co., Ltd.20191—
+5K182284Tyber Medical PT Interbody SpacerTyber Medical, LLC20195—
+5K182584Lucent® XPSpinal Elements, Inc.20183—
+5K181837Spinal Elements Ti-Bond coated devicesSpinal Elements, Inc.201898—
+5K181818Scarlet AL-TSpineart201864—
+5K181397DualXInnovasive, Inc.201815—
+5K181386NuVasive Brigade Lateral SystemNu Vasive, Incorporated2018158—
+5K180076Ti 3Z Interbody SystemZavation Medical Products, LLC20184—
+5K181203Juliet TiSpineart20181—
+5K173892NuVasive® XLX Interbody SystemNu Vasive, Incorporated2018115—
+5K173082Arco™-SA Lumbar Cage SystemNeurostructures, Inc.20185—
+5K173702Juliet Ti LLSpineart20182—
+5K172083Idys™ ALIF SystemClariance, Sas20177—
+5K172123NuVasive® Modulus XLIF Interbody SystemNu Vasive, Incorporated2017227—
+5K171633NuVasive TLX Interbody SystemNu Vasive, Incorporated2017251—
+5K163422Shanghai Sanyou PEEK Cage SystemShanghai Sanyou Medical Co, Ltd.20173—
+5K171496Tritanium C Anterior Cervical CageStryker Spine2017129—
+5K170851Anterior Spine Truss System (STS) Interbody Fusion Device4Web, Inc.20175—
+5K171630LumFuse-TPPrecifit Medical, Ltd.20171—
+5K170962NuVasive® CoRoent® Thoracolumbar SystemNu Vasive, Incorporated2017304—
+5K163707NuVasive CoRoent Ti-C SystemNu Vasive, Incorporated201719—
+5K170592NuVasive BASE Interfixated Titanium SystemNu Vasive, Incorporated2017186—
+5K163230NuVasive Modulus XLIF Interbody SystemNu Vasive, Incorporated2017276—
+5K162680SOVEREIGN® Spinal SystemMedtronic Sofamor Danek USA, Inc.201631—
+5K160959Xsert Lumbar Expandable Interbody SystemX-Spine Systems, Inc.201612—
+5K162262Tritanium® PL CageStryker2016132—
+5K161379ELSA SpacersGlobus Medical, Inc.2016155—
+5K161173Avenue® T TLIF CageLdr Spine USA, Inc.20163—
+5K160955Tritanium® PL CageStryker2016178—
+5K160715AccuLIF TL and PL CageStryker Corporation20160—
+5K160125Cascadia Interbody SystemK2m2016315—
+5K153419NuVasive CoRoent Thoracolumbar SystemNu Vasive, Incorporated2016400—
+5K153495Avenue L Lateral Lumbar Cage, Avenue T TLIF Cage System, ROI-A ALIF Cage System, ROI-T…Ldr Spine USA20161891
+5K151310Amendia Interbody Fusion DevicesAmendia, Inc.2016169—
+5K143479Bluefin Interbody SystemTides Medical20152—
+6K262067iFuse Granite Onyx™ Implant SystemSI-BONE, Inc.20260—
+6K261809Interwedge® Standalone LateralFoundation Surgical Group20260—
+6K262061Tritanium® C Anterior Cervical Cage; Tritanium® PL Cage; Tritanium® TL Curved Posterior…Stryker Spine20260—
+6K261284Invictus® Small Stature Spinal Fixation System; Invictus® 2.0 Spinal Fixation SystemAlphatec Spine, Inc.20260—
+6K253420Admiral ACP System; Explorer TO System; Laminoplasty System; Manta Ray TDF Spacer…SeaSpine Orthopedics Corporation20260—
+6K261665CORUS™ Navigation System-GNProvidence Medical Technology, Inc.20260—
+6K261060Navigated LLIF Impactable TrackerTyber Medical, LLC20260—
+6K253401SCRIPT™ Implant SystemGlobus Medical, Inc.20260—
+6K254274ARx® SAI Implant SystemLife Spine, Inc.20260—
+6K254017SWINGO-3D Lumbar Cage SystemImplanet20260—
+6K252610ZSFab Lumbar Interbody SystemZsfab, Inc.20251—
+6K250599ExcelsiusGPS™ InstrumentsGlobus Medical, Inc.20250—
+6K252322SIros-X SystemGenesys Spine20250—
+6K253094iFuse Bedrock Granite Implant SystemSI-BONE, Inc.20250—
+6K251575IdentiTi™ II ALIF Standalone Interbody System; Transcend™ ALIF Standalone Interbody SystemAlphatec Spine20250—
+6K252113PRADO™ Lumbar Interbody Fusion SystemBethesda Medical Devices20250—
+6K251060CORUS™ Navigation System-GXProvidence Medical Technology, Inc.20250—
+6K250072CONDUIT™ SYNFIX™ Evolution Secured Spacer SystemAvalign Technologies, Inc.20251—
+6K241525ExcelsiusXR™Globus Medical, Inc.20250—
+6K251080IdentiTi II Cervical Interbody SystemAlphatec Spine, Inc.20250—
+6K251617X-PAC® TLIF Expandable Posterior Cage System; X-PAC® LLIF Expandable Lateral Cage SystemExpanding Innovations, Inc.20250—
+6K251459OneLIF™ Interbody Fusion SystemNovapproach Spine, LLC20250—
+6K243386Ventris Intervertebral Body Fusion DeviceAcuity Surgical Devices, LLC20252—
+6K243802aprevo® anterior and lateral lumbar interbody fusion device, aprevo® anterior lumbar…Carlsmed, Inc.20253—
+6K250605EVOL® ha – Hyper C Cervical Interbody Fusion SystemCutting Edge Spine, LLC20250—
+6K243461Calibrate Interbody SystemsAlphatec Spine, Inc.20250—
+6K243814NuVasive Pulse SystemGlobus Medical, Inc.20250—
+6K242517ProAM ACDF SystemPro Surgical, Inc.20240—
+6K242734ZSFab Cervical Interbody System; ZSFab Lumbar Interbody SystemZsfab20243—
+6K242589Scarlet® AL-TSpineart SA20240—