510(k) Report

Devices descending from K121760

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

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+6K251479Mobarn 80:20 Lumbar Interbody Fusion System (Posterior Lumbar Interbody Fusion Cage…Mobarn Medical Devices, LLC20250—
+6K251444Endoskeleton™ Interbody SystemsMedtronic Sofamor Danek USA, Inc.20250—
+6K251502TruLift® Lateral Expandable Spacer & Lateral Buttress Plate SystemLife Spine, Inc.20250—
+6K251644ProAM ALIF SystemPro Surgical, Inc.20250—
+6K251335Tera Lumbar Interbody Fusion System (Various PNs)Acuity Surgical Devices, LLC20251—
+6K243116FlareHawk Interbody Fusion SystemIntegrity Implants Inc. Dba Accelus20250—
+6K243934Stable-L Lumbar Interbody SystemNexus Spine, LLC20250—
+6K250521NanoBone® SBX Putty ; NanoBone® QDBiocomposites, Ltd.20250—
+6K243074Spectrum Spine Lumbar Cage SystemSpectrum Spine, Inc.20252—
+6K250556Porous Biologic ScaffoldVentris Medical20250—
+6K243668ProLift Pivot Expandable Spacer SystemLife Spine, Inc.20250—
+6K243706Mastergraft Matrix EXT; Mastergraft Strip; Mastergraft Putty; Mastergraft GranulesMedtronic Sofamor Danek, Inc.20250—
+6K241167BioSphere Putty; BioSphere MIS PuttySynergy Biomedical20240—
+6K243671ExcelsiusGPS® InstrumentsGlobus Medical, Inc.20240—
+6K241468Vertiwedge® Intraosseous SystemFoundation Surgical Group, Inc.20241—
+6K242350Spinal Alignment Solutions Pelvic Incidence (PI) Rod SystemSpinal Alignment Solutions, Inc.20241—
+6K240889ARTFX Lumbar PEEK CagesArtfx Medical20244—
+6K242299NovaBone Putty - Synthetic Bioactive Bone GraftNovabone Products, LLC20241—
+6K242273Cove Putty, OsteoCove PuttySeaSpine Orthopedics Corporation202402
+6K242509HAnano InterFuse (R) Modular InterbodyNext Orthosurgical20240—
+6K241738PYXIS 3D Titanium Cervical Cage systemGS Medical Co., Ltd.20241—
+6K241413sagAlign Lumbar Cage System (Various PNs)Acuity Surgical Devices, LLC20240—
+6K241467Stable-C Interbody SystemNexus Spine, LLC20242—
+6K240721ExcelsiusFlex™Globus Medical, Inc.20240—
+6K240838Spectrum Spine Cervical Cage SystemSpectrum Spine, Inc.20244—
+6K240749PILLAR SA Ti Spacer System (82-XXX)Orthofix, Inc.202402
+6K240566Reef L Interbody System; WaveForm L Interbody SystemSeaSpine Orthopedics Corporation20245—
+6K232792icotec Interbody Cage System (icotec Cervical Cage, icotec PLIF Lumbar Cage, icotec…Icotec AG20240—
+6K240442MagnetOs PuttyKuros Biosciences B.V20243—
+6K240715Idys® C ZP 3DTiClariance20240—
+6K240507NuVasive AttraX ScaffoldNuvasive, Inc.20240—
+6K233375Tranquil-L Interbody SystemNexus Spine, LLC20240—
+6K231850QUARTEX® Occipito-Cervico-Thoracic Spinal System ExcelsiusGPS® InstrumentsGlobus Medical, Inc.20242—
+6K240416Tranquil-C Interbody SystemNexus Spine, LLC20243—
+6K240458Synthetic Bone PuttyVentris Medical20242—
+6K240459Cerament Bone Void FillerBonesupport AB20240—
+6K232432E3D™-A Interbody SystemEvolution Spine20248—
+6K232347MagnetOs GranulesKuros Biosciences B.V20242—
+6K233607MagnetOs Easypack PuttyKuros Biosciences B.V20232—
+6K233490SIGNAFUSE Bioactive Strip (SBS); SIGNAFUSE PuttyBioventus, LLC20232—
+6K233191TotalTi ACDF by SAGICOSpinal Analytics & Geometrical Implant Co, LLC20230—
+6K233084Peridot-PT Anterior Cervical Intervertebral body fusion System, Peridot-PT…Gbs Commonwealth Co., Ltd.20232—
+6K233245MagnetOs Flex MatrixKuros Biosciences B.V20230—
+6K230927OptiMesh Multiplanar Expandable Interbody Fusion SystemSpineology, Inc.20231—
+6K232173Ascend VBR System, Ascend NanoTec VBR SystemAlphatec Spine, Inc.20230—
+6K232315Catalyst Bone Void FillerOssdsign AB20237—
+6K232154MiRus 3DR Lateral Lumbar Interbody Fusion System with Integrated Plate FixationMiRus, LLC20230—
+6K222988neoWave LS Lumbar Straight, neoWave C Cervical, and Ti3D CervicalHt Medical D.B.A. Xenix Medical20232—
+6K221138Titus Titanium Cervical by SAGICOSagico VA USA, LLC20231—
+6K231275Exceed™ Biplanar Expandable Interbody SystemSpine Wave, Inc.20232—
+6K231241NanoHive Medical Lumbar Interbody SystemNanoHive Medical, LLC20230—
+6K231735NuVasive CoRoent Small Interbody System; NuVasive CoRoent Small Contoured Interbody…Nu Vasive, Incorporated20239—
+6K222015Integral Titanium Cervical InterbodyNvision Biomedical Technologies, Inc.20231—
+6K230731Zavation ALIF SystemZavation Medical Products, LLC20232—
+6K230708Peridot-TD Spacer system (The Peridot-TD Intervertebral body fusion system); Anterior…Gbs Commonwealth Co., Ltd.20233—
+6K223335SIRION Lateral Lumbar Interbody SystemAstura Medical20230—
+6K220513NITRO Interbody Fusion Cage System FamilyCtl Medical Corporation20230—
+6K223513UniVy™ OsteoVy™-Ti Cervical IBF SystemVy Spine, LLC20231—
+6K223765ATEC Lateral Navigation InstrumentsAlphatec Spine, Inc.202302
+6K223837SPIRA®-C Integrated Fixation SystemCamber Spine Technologies20230—
+6K223231Ti-Largo Cervical Interbody SystemFlospine20230—
+6K223362Cervical Spine Truss System - Stand Alone (CSTS-SA) Interbody Fusion Device4Web Medical, Inc.20233—
+6K222554EL CAPITAN Anterior Lumbar Interbody FusionAstura Medical20235—
+6K221266Cervical Spine Truss System (CSTS) Interbody Fusion Device4Web Medical, Inc.20233—
+6K222806Kodiak C Spinal Implant SystemMet One Technologies, LLC20221—
+6K223140AEON-C™ Stand Alone SystemDio Medical, Inc.20222—
+6K221926Invictus® Bone Cement, Invictus Spinal Fixation SystemAlphatec Spine, Inc.202214—
+6K221182Southern Transforaminal Lumbar Interbody Fusion (TLIF)Southern Medical (Pty), Ltd.20220—
+6K221806TruLift Lateral Expandable Spacer System & Lateral Plate SystemLife Spine, Inc.20221—
+6K222973IdentiTi and Transcend Interbody Systems: IndentiTi Cervical Porous Ti Interbody System…Alphatec Spine, Inc.202213—
+6K221162UniVy OsteoVy Cervical IBF SystemVy Spine, LLC20222—
+6K222276CONDUIT Cages; FIBERGRAFT BG PuttyDepuy Spine202229—
+6K213641MONDRIAN ALIF Cage with Supplementary Fixation PlateCtl Medical Corporation20221—
+6K221049Zavation VariSync Plate System and VariSync Spacer SystemZavation Medical Products, LLC20226—
+6K213791Unispace SA Cervical CageEdisoninno Co., Ltd.20222—
+6K220449DePuy CONDUIT LLIF SQUID InserterEnztec Limited20220—
+6K212527Cervical Spine Truss System Plating Solution (CSTS-PS)4Web Medical, Inc.20220—
+6K220115ANTARES 3DR Standalone Anterior Lumbar Interbody Fusion SystemMiRus, LLC20220—
+6K213420WaveForm L System, WaveForm TO System, WaveForm TA SystemSeaSpine Orthopedics Corporation202211—
+6K211837Altus Spine Interbody Standalone Fusion SystemAltus Partners, LLC20220—
+6K214047EL CAPITAN Anterior Lumbar Interbody Fusion SystemAstura Medical20223—
+6K202266Reliance Cervical IBF SystemReliance Medical Systems, LLC20223—
+6K213355Toro-L Interbody Fusion SystemIntegrity Implants, Inc.20224—
+6K212904SeaSpine WaveForm C Interbody SystemSeaSpine Orthopedics Corporation202115—
+6K213359SeaSpine WaveForm, C Interbody SystemSeaSpine Orthopedics Corporation20217—
+6K212075ShurFit Lumbar Interbody SystemPrecision Spine, Inc.20211—
+6K211845Deploy Expandable Interbody SystemSouthern Spine, LLC20210—
+6K212823DePuy CONDUIT LLIF Angled InsertersEnztec Limited20213—
+6K211474Kleiner KG2 SystemBAAT Medical Products B.V.20210—
+6K211449Triton™ Sacroiliac Joint Fixation SystemChoice Spine, LLC20211—
+6K212070KMTI S141 Lumbar Interbody Fusion SystemKyocera Medical Technologies, Inc.20210—
+6K211413BEE PLIF CageNGMedical GmbH20211—
+6K210521DEXA-C Cervical Interbody SystemAurora Spine, Inc.20210—
+6K203003Pantheon IBFDPantheon Spinal20210—
+6K211441Navigated Anterolateral Disc Prep InstrumentsMedtronic Sofamor Danek USA, Inc.20219—
+6K203311ChoiceSpine Blackhawk Ti Cervical Spacer SystemChoice Spine, LLC20213—
+6K210728CONDUIT InstrumentsMedos International SARL20215—
+6K203342CONSTRUX Mini Ti Spacer SystemOrthofix, Inc.202191
+6K210359Hexanium TLIFSpinevision, S.A.S.20211—
+6K203153CREO Stabilization System, Navigation Instruments, ExcelsiusGPSGlobus Medical, Inc.20211—