510(k) Report

Devices descending from K073291

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

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+6K243915FIX-C 3D Ti ACIF SystemJeil Medical Corporation20250—
+6K243706Mastergraft Matrix EXT; Mastergraft Strip; Mastergraft Putty; Mastergraft GranulesMedtronic Sofamor Danek, Inc.20250—
+6K241167BioSphere Putty; BioSphere MIS PuttySynergy Biomedical20240—
+6K241477aprevo® anterior lumbar interbody fusion device with interfixationCarlsmed, Inc.20246—
+6K242299NovaBone Putty - Synthetic Bioactive Bone GraftNovabone Products, LLC20241—
+6K242273Cove Putty, OsteoCove PuttySeaSpine Orthopedics Corporation202402
+6K233807LumiVy™ Lumbar IBF SystemVy Spine, LLC20241—
+6K241332aprevo® anterior and lateral lumbar interbody fusion device; aprevo® anterior lumbar…Carlsmed, Inc.20245—
+6K242509HAnano InterFuse (R) Modular InterbodyNext Orthosurgical20240—
+6K241504iFuse TORQ TNT™ Implant SystemSI-BONE, Inc.20240—
+6K241328aprevo® Anterior and Lateral Lumbar Interbody Fusion device (ALIF/LLIF); aprevo®…Carlsmed, Inc.20240—
+6K241413sagAlign Lumbar Cage System (Various PNs)Acuity Surgical Devices, LLC20240—
+6K240505Eminent Spine SI Screw SystemEminent Spine, LLC20241—
+6K241396uCerv Flux™-C 3D Porous Titanium Cervical InterbodyUlrich Medical USA, Inc.20240—
+6K240566Reef L Interbody System; WaveForm L Interbody SystemSeaSpine Orthopedics Corporation20245—
+6K234119UniSpace® Stand-Alone C CageInnosys Co., Ltd.20241—
+6K240720TiLink-P SI Joint Fusion SystemSurGenTec, LLC20243—
+6K233509Zavation IBF System, Zavation Varisync Plate System and Varisync Spacer System…Zavation Medical Products, LLC20241—
+6K240442MagnetOs PuttyKuros Biosciences B.V20243—
+6K234150Lucent® XPSpinal Elements20240—
+6K240715Idys® C ZP 3DTiClariance20240—
+6K232282aprevo® anterior and lateral lumbar interbody fusion device, aprevo® transforaminal…Carlsmed, Inc.20240—
+6K240507NuVasive AttraX ScaffoldNuvasive, Inc.20240—
+6K240458Synthetic Bone PuttyVentris Medical20242—
+6K240459Cerament Bone Void FillerBonesupport AB20240—
+6K233640Segmental Plating System (SPS);IdentiTi SPS Interbody System;IdentiTi NanoTec SPS…Alphatec Spine, Inc.20245—
+6K232432E3D™-A Interbody SystemEvolution Spine20248—
+6K232347MagnetOs GranulesKuros Biosciences B.V20242—
+6K233607MagnetOs Easypack PuttyKuros Biosciences B.V20232—
+6K233490SIGNAFUSE Bioactive Strip (SBS); SIGNAFUSE PuttyBioventus, LLC20232—
+6K230639Align Cervical Interbody Fusion SystemAcuity Surgical Devices, LLC20232—
+6K233245MagnetOs Flex MatrixKuros Biosciences B.V20230—
+6K233443Vital™ Navigation SystemZimvie Spine (Zimmer Biomet Spine, Inc.)20230—
+6K230927OptiMesh Multiplanar Expandable Interbody Fusion SystemSpineology, Inc.20231—
+6K232878TransLoc 3DFoundation Fusion Solutions, LLC (Dba Cornerloc)20230—
+6K231486Stable-L Standalone Lumbar Interbody SystemNexus Spine, LLC20231—
+6K232173Ascend VBR System, Ascend NanoTec VBR SystemAlphatec Spine, Inc.20230—
+6K232605Sacrix® Sacroiliac Joint Fusion Device System, Inspan® ScrewLES Fusion System, Invue®…Lesspine Innovations20230—
+6K231076VariLift®-C Interbody Fusion SystemWenzel Spine, Inc.20234—
+6K232530Stable-L Standalone Lumbar Interbody System, Stable-C Interbody SystemNexus Spine, LLC20235—
+6K232315Catalyst Bone Void FillerOssdsign AB20237—
+6K232154MiRus 3DR Lateral Lumbar Interbody Fusion System with Integrated Plate FixationMiRus, LLC20230—
+6K232150ZSFab Cervical Interbody SystemZsfab, Inc.20234—
+6K231951SI-Cure Sacroiliac Joint Fusion SystemAlevio, LLC20231—
+6K231689iFuse TORQ® Implant SystemSI-BONE, Inc.20235—
+6K230861VADER® Pedicle System Navigated InstrumentsIcotec AG20230—
+6K231140aprevo® transforaminal lumbar interbody fusion deviceCarlsmed, Inc.20236—
+6K230989Rod Registration FrameNu Vasive, Incorporated20230—
+6K223868PYXIS 3D Titanium Cage SystemGS Medical Co., Ltd.20232—
+6K223513UniVy™ OsteoVy™-Ti Cervical IBF SystemVy Spine, LLC20231—
+6K221324ENZA-O Titanium Lateral Anterior Lumbar Interbody Fusion (ALIF)Camber Spine Technologies20230—
+6K223231Ti-Largo Cervical Interbody SystemFlospine20230—
+6K223174X-Pac Expandable LLIF Cage SystemExpanding Innovations, Inc.20233—
+6K220296Manta Ray TDF SpacerSeaSpine Orthopedics Corporation20231—
+6K223474PathLoc-TA Expandable Lumbar Cage SystemL&K BIOMED Co., Ltd.20231—
+6K223412LumiVy™ Lumbar IBF SystemVy Spine, LLC20235—
+6K221926Invictus® Bone Cement, Invictus Spinal Fixation SystemAlphatec Spine, Inc.202214—
+6K223190Hive™ Standalone Cervical SystemNanoHive Medical, LLC20225—
+6K211785CASSATT™ SIJ Fixation SystemCtl Medical Corporation20220—
+6K222276CONDUIT Cages; FIBERGRAFT BG PuttyDepuy Spine202229—
+6K222605iFuse TORQ® Implant SystemSI-BONE, Inc.202214—
+6K220696uCerv Flux-C 3D Porous Titanium Cervical InterbodyUlrich Medical USA20221—
+6K221049Zavation VariSync Plate System and VariSync Spacer SystemZavation Medical Products, LLC20226—
+6K213667iFuse-TORQ® Implant SystemSI-BONE, Inc.202215—
+6K212811Ti3Z Lumbar Interbody SystemZavation Medical Products, LLC20223—
+6K213654NuVasive Reline Cervical SystemNu Vasive, Incorporated20221—
+6K212980Tesera-k ALIF SystemKyocera Medical Technologies, Inc.20222—
+6K213720Vital Navigation SystemZimvie (Zimmer Biomet Spine, Inc.)20220—
+6K210590Axis Spine Technologies ALIFAxis Spine Technologies, Ltd.20210—
+6K211704CONSTRUX Mini PEEK Spacer System/CONSTRUX Mini PEEK VBR System, CONSTRUX Mini PTC Spacer…Orthofix, Inc.20215—
+6K211993Z-LINKPC SystemZavation Medical Products, LLC20210—
+6K203311ChoiceSpine Blackhawk Ti Cervical Spacer SystemChoice Spine, LLC20213—
+6K210155Duo Expandable Interbody Fusion SystemSpineology, Inc.20210—
+6K203327VERTACONNECT TLIF CageSignus Medizintechnik20210—
+6K202488ZSFab Cervical Interbody SystemZsfab, Inc.20216—
+6K202637F3D Corpectomy SystemCorelink, LLC20201—
+6K202298Lucent XP, Lucent XP CurvedSpinal Elements, Inc.20202—
+6K202812IdentiTi Cervical Standalone Interbody SystemAlphatec Spine, Inc.202067—
+6K200549Lucero Medical Cervical Cage SystemLucero Medical, LLC20200—
+6K202587ATEC Lateral Interbody SystemAlphatec Spine, Inc.202039—
+6K202198FlareHawk Interbody Fusion SystemIntegrity Implants, Inc.20202—
+6K201367FlareHawk TiHawk9 Interbody Fusion SystemIntegrity Implants, Inc.20202—
+6K201073Seaspine WaveForm C Interbody SystemSeaSpine Orthopedics Corporation202017—
+6K201646Shoreline ACS (Anterior Cervical System)SeaSpine Orthopedics Corporation202020—
+6K201605EIT Cellular Titanium Cervical Cage, EIT Cellular Titanium ALIF Cage, EIT Cellular…Eit Emerging Implant Technologies GmbH2020130—
+6K201614TxTiHA IBF System, AxTiHA Stand-Alone ALIF SystemInnovasis, Inc.2020471
+6K200685RIGEL 3DR Anterior Cervical Interbody Fusion SystemMiRus, LLC20200—
+6K200235KONG-TL VBR System, KONG-C VBR SystemIcotec AG20201—
+6K200352Axis Spine Technologies ALIFAxis Spine Technologies, Ltd.20202—
+6K192145Galileo Vertebral Body Replacement DeviceBright Spine20201—
+6K192897icotec Cervical CageIcotec AG20201—
+6K193359SureMAX Family of Cervical SpacersAdditive Implants, Inc.202014—
+6K191834Stand-Alone ALIF Titanium SystemLife Spine, Inc.20190—
+6K192938Invictus™ Spinal Fixation SystemAlphatec Spine, Inc.201969—
+6K192132SeaSpine Beachside SystemSeaSpine Orthopedics Corporation2019591
+6K191477AEON-C Stand Alone SystemHuvexel Co., Ltd.201910—
+6K1803473d CageFims Co., Ltd.20190—
+6K190636NuVasive® Reline® 4.5-5.0 SystemNu Vasive, Incorporated201913—
+6K192208CORNICE Cervical Spacer SystemLegend Spine Technologies20190—
+6K191537eCarbon IBDsBack 2 Basics Direct, LLC20193—