510(k) Report

Devices descending from K103731

907 later devices reach Capstone R Spinal System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+5K232530Stable-L Standalone Lumbar Interbody System, Stable-C Interbody SystemNexus Spine, LLC20235—
+5K222988neoWave LS Lumbar Straight, neoWave C Cervical, and Ti3D CervicalHt Medical D.B.A. Xenix Medical20232—
+5K231944CATAMARAN SI Joint Fusion SystemTenon Medical, Inc.20234—
+5K232150ZSFab Cervical Interbody SystemZsfab, Inc.20234—
+5K232141CD Horizon ModuLeX FNS Screw Set (Fenestrated Screw); CD Horizon ModuLeX Spinal System…Medtronic Sofamor Danek USA, Inc.20231—
+5K230607SPICCA Cervical Fusion CagesSouthern Medical (Pty), Ltd.20230—
+5K231280CarboClear® X Pedicle Screw System; CarboClear® X Navigated Instruments; CarboClear® X…CarboFix Orthopedics, Ltd.20234—
+5K230894NuVasive Modulus ALIF SystemNu Vasive, Incorporated20234—
+5K231199Solar Lumbar Interbody Fusion SystemDegen Medical20235—
+5K223335SIRION Lateral Lumbar Interbody SystemAstura Medical20230—
+5K230880CoreLink Navigation InstrumentsCorelink, LLC20230—
+5K220274Kisar Stratford SI Screw SystemAnjali Investments L.L.C20230—
+5K223326Axiom PSR SystemRestor3D202301
+5K213815SiJoin®T3Vgi Medical, Inc.20230—
+5K223837SPIRA®-C Integrated Fixation SystemCamber Spine Technologies20230—
+5K223708Entasis 3D Dual-Lead Sacroiliac Implant SystemCorelink, LLC20233—
+5K223418DeGen Impulse AM™ SystemDegen Medical20236—
+5K223146EVOLUTION SPINE Interbody SystemEvolution Spine20239—
+5K222554EL CAPITAN Anterior Lumbar Interbody FusionAstura Medical20235—
+5K223819SI-Cure Sacroiliac Joint Fusion SystemAlevio, LLC20232—
+5K223731NuVasive Modulus-C Interbody SystemNuvasive, Inc.202311—
+5K223649VERTICALE® Navigation InstrumentsSilony Medical GmbH20223—
+5K221806TruLift Lateral Expandable Spacer System & Lateral Plate SystemLife Spine, Inc.20221—
+5K222009aprevo® anterior lumbar interbody fusion device with interfixationCarlsmed, Inc.202212—
+5K222455Calibrate LTX Interbody SystemAlphatec Spine, Inc.20228—
+5K222732WaveForm A Interbody SystemSeaSpine Orthopedics Corporation20229—
+5K221751NuVasive Cohere ALIF System Intervertebral Body Fusion DeviceNu Vasive, Incorporated20223—
+5K222203DualXSLIM (R) T/PLIFAmplify Surgical, Inc.20223—
+5K221936Standalone ALIF Interbody Fusion SystemEminent Spine20222—
+5K221646CD HORIZON™ ASTUTE™ SPINAL SYSTEM; CD HORIZON™ Growth Rod Conversion Set; CD HORIZON™…Medtronic Sofamor Danek USA, Inc.202220—
+5K222561AlignAcuity Surgical Devices, LLC202214—
+5K203503Camber Sacroiliac (SI) Fixation SystemCamber Spine Technologies, LLC20222—
+5K221325CONDUIT Lateral Switch PlateMedos International SARL20221—
+5K220696uCerv Flux-C 3D Porous Titanium Cervical InterbodyUlrich Medical USA20221—
+5K222082aprevo® anterior and lateral lumbar interbody fusion devices, aprevo® transforaminal…Carlsmed, Inc.202211—
+5K211496TransLoc 3DFoundation Fusion Solutions, LLC (Dba Cornerloc)20227—
+5K221535Align Lumbar Interbody Fusion SystemAcuity Surgical Devices, LLC20223—
+5K220782IdentiTi™ Porous Ti Interbody System, IdentiTi™ NanoTec™ Interbody System, Transcend™…Alphatec Spine, Inc.202236—
+5K220581Zavation eZspand Interbody SystemZavation Medical Products, LLC20224—
+5K220610SOLO-LAurora Spine, Inc.20220—
+5K220115ANTARES 3DR Standalone Anterior Lumbar Interbody Fusion SystemMiRus, LLC20220—
+5K213935PISCES-SA Standalone ALIF Interbody SystemOsseus Fusion Systems202212—
+5K212811Ti3Z Lumbar Interbody SystemZavation Medical Products, LLC20223—
+5K212962TRELLIS™ SI Joint Fusion SystemOrthofundamentals, LLC20220—
+5K214006Invictus® Spinal Fixation SystemAlphatec Spine, Inc.202216—
+5K213118Dakota ALIF SystemPrecision Spine, Inc.20220—
+5K214047EL CAPITAN Anterior Lumbar Interbody Fusion SystemAstura Medical20223—
+5K220453FlareHawk Interbody Fusion SystemIntegrity Implants, Inc.20221—
+5K213980Peridot Spinal Interbody SystemGbs Commonwealth Co., Ltd.20224—
+5K211417F3D-C2 Cervical Stand-Alone SystemCorelink, LLC20223—
+5K214059CoreLink Navigation InstrumentsCorelink, LLC20220—
+5K203714NuVasive Thoracolumbar Interbody Systems: NuVasive CoRoent Thoracolumbar System…Nu Vasive, Incorporated202166—
+5K212562Idys-C ZP 3DTiClariance, SA20211—
+5K210590Axis Spine Technologies ALIFAxis Spine Technologies, Ltd.20210—
+5K211740DualXAmplify Surgical, Inc.20211—
+5K211805IdentiTi Porous Ti Interbody System, Transcend PEEK Interbody System, IdentiTi NanoTec…Alphatec Spine, Inc.202138—
+5K210402Curiteva Sacroiliac Joint Fusion SystemCuriteva, Inc.20212—
+5K210470C-CURVE Interbody Fusion DeviceMedicrea International SA20210—
+5K211704CONSTRUX Mini PEEK Spacer System/CONSTRUX Mini PEEK VBR System, CONSTRUX Mini PTC Spacer…Orthofix, Inc.20215—
+5K210800IO Expandable Lumbar Interbody Fusion SystemMiRus, LLC20212—
+5K211388Lateral Spine Truss System (LSTS) Interbody Fusion Device4Web Medical, Inc.20210—
+5K210574NuVasive Pulse SystemNu Vasive, Incorporated202121
+5K210595SPIRA-T Oblique Posterior Lumbar Spacers, SPIRA-P Posterior Lumbar SpacersCamber Spine Technologies, LLC20213—
+5K211258Endoskeleton TC Interbody System, Endoskeleton TCS Interbody System, Endoskeleton TA…Medtronic Sofamor Danek USA, Inc.202175—
+5K210214NuVasive Modulus Expandable Posterior Lumbar MOD-EX PL Interbody SystemNu Vasive, Incorporated20213—
+5K210061ProLift Lateral HELO FixatedLife Spine, Inc.20213—
+5K203038Toro-L Interbody Fusion SystemIntegrity Implants, Inc.20215—
+5K203361ProLift Wedge Expandable Spacer SystemLife Spine, Inc.20211—
+5K210271NuVasive Modulus ALIF SystemNu Vasive, Incorporated20215—
+5K203247iFuse-TORQ™ Implant SystemSI-BONE, Inc.2021171
+5K202872Prase PEEK Anterior Cervical Interbody SpacerGbs Commonwealth Co., Ltd.20215—
+5K202398Ti3Z Cervical Interbody SystemZavation Medical Products, LLC20219—
+5K203153CREO Stabilization System, Navigation Instruments, ExcelsiusGPSGlobus Medical, Inc.20211—
+5K202488ZSFab Cervical Interbody SystemZsfab, Inc.20216—
+5K200458Tailored-C Cervical Interbody Fusion SystemBespoke Technologies20203—
+5K202298Lucent XP, Lucent XP CurvedSpinal Elements, Inc.20202—
+5K201643ChoiceSpine Tiger Shark Cervical Spacer SystemChoice Spine, LLC20204—
+5K200549Lucero Medical Cervical Cage SystemLucero Medical, LLC20200—
+5K201755WaveForm L Interbody System, WaveForm TO Interbody System, WaveForm TA Interbody SystemSeaSpine Orthopedics Corporation202017—
+5K201692NuVasive Modulus XLIF Interbody SystemNu Vasive, Incorporated202067—
+5K200953NuVasive® Cohere® Thoracolumbar Interbody SystemNu Vasive, Incorporated2020141—
+5K202190Oculus-SA Lumbar Cage SystemNeurostructures20200—
+5K192863MONDRIAN Lumbar Interbody Fusion Cage SystemCtl Medical Corporation20203—
+5K201087CORBEL SpacersGlobus Medical, Inc.202036—
+5K200352Axis Spine Technologies ALIFAxis Spine Technologies, Ltd.20202—
+5K200338ProLift Lateral FixatedLife Spine, Inc.20205—
+5K200613Tritanium® X TL Expandable Curved Posterior Lumbar CageStryker Corporation20205—
+5K193541NuVasive Cohere Thoracolumbar Interbody SystemNu Vasive, Incorporated2020157—
+5K192897icotec Cervical CageIcotec AG20201—
+5K193506NuVasive X-Core Expandable VBR System, NuVasive X-Core Mini Cervical Expandable VBR SystemNu Vasive, Incorporated20201—
+5K193255Largo PEEK Interbody SystemFlospine, LLC20201—
+5K191581Endoskeleton TL Interbody Fusion Device, Endoskeleton TL Hyperlordotic Interbody Fusion…Titan Spine, Inc.202081—
+5K193359SureMAX Family of Cervical SpacersAdditive Implants, Inc.202014—
+5K191834Stand-Alone ALIF Titanium SystemLife Spine, Inc.20190—
+5K191722Vital Navigation SystemZimmer Biomet Spine, Inc.20192—
+5K191477AEON-C Stand Alone SystemHuvexel Co., Ltd.201910—
+5K192434DualX Lumbar Intervertebral Body Fusion DeviceAmplify Surgical, Inc.20190—
+5K192208CORNICE Cervical Spacer SystemLegend Spine Technologies20190—
+5K191537eCarbon IBDsBack 2 Basics Direct, LLC20193—
+5K192054Endoskeleton TAS PlateTitan Spine, Inc.20190—