510(k) Report

Devices descending from K082342

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

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+7K171686Choice Spine Hawkeye™ Vertebral Body Replacement (VBR) SystemChoicespine2017116—
+7K171351Posterior Spine Truss System (PSTS) Interbody Fusion Device4Web, Inc.20177—
+7K171893Blustone Synergy Lumbar Interbody Fusion System (Basalt, Magma, Obsidian), Blustone…Bluestone Synergy20172—
+7K171704CAPRI Corpectomy Cage SystemK2m201710—
+7K171097MOJAVE Expandable Interbody SystemK2m, Inc.201717—
+8K263172SAS MIS Pelvic Incidence RodsSpinal Alignment Solutions, Inc.20260—
+8K262230Mg OSTEOREVIVE™;Mg OSTEOCRETE™Bone Solutions, Inc.20260—
+8K262828KHEIRON® Spinal Fixation System, including patient specific K-RODS.M.A.I.O20260—
+8K261882Pisces-SC Standalone Cervical Interbody SystemOsseus Fusions Systems, LLC20260—
+8K261810Vertiwedge® Intraosseous SystemFoundation Surgical Group20260—
+8K261205SPINEART Navigation Instrument SystemSpineart SA20260—
+8K261353Tesera-K Anterior Lumbar Interbody Fusion (ALIF) System; Tesera-K XL System; Lumbar…Kyocera Medical Technologies, Inc.20260—
+8K254130C.A. Medical Interbody Fusion SystemC.A. Medical, LLC20260—
+8K261279DeltaNEC Interbody SystemNexus Spine20260—
+8K261159Exceed® Biplanar Expandable Interbody SystemSpine Wave, Inc.20260—
+8K260837VersaLift Expandable SystemLife Spine, Inc.20260—
+8K260385aprevo® anterior and lateral lumbar interbody system; aprevo® posterior and…Carlsmed, Inc.20260—
+8K253739SCRIPT™ Rods, CREO™ Stabilization System, REVERE® Stabilization System, REVERE® 4.5…Globus Medical, Inc.20260—
+8K260340HC Biologics Osteopoint Peek Cages, HC Biologics Osteopoint Cervical Peek Cages, HC…HC Biologics, LLC20260—
+8K252240Spectrum Spine Cervical Cage System; Spectrum Spine Lumbar Cage SystemSpectrum Spine20260—
+8K253583LUX Expandable Lumbar Interbody SystemXenix Medical20260—
+8K252205Curiteva Porous PEEK Cervical Interbody System; Curiteva Porous PEEK Lumbar Interbody…Curiteva, Inc.20260—
+8K251302OptiMesh Multiplanar Expandable Interbody Fusion SystemSpineology, Inc.20250—
+8K253200Cervical Spine Truss System - Stand Alone (CSTS-SA)4Web Medical, Inc.20250—
+8K252686EffortMed PEEK Cages & Corpectomy CagesEffortmed, LLC20251—
+8K252327CMORE® CT System; CMORE® CT System Navigated InstrumentsIcotec AG20251—
+8K253377Expandable Titanium PLIF/TLIF SystemSpectrum Spine, Inc.20250—
+8K253147FIBERGRAFT™ BG Putty GPS Bone Graft Substitute FIBERGRAFT™ BG Putty Bone Graft…Prosidyan, Inc.20250—
+8K250335IVA & AEON Cervical and Lumbar Cage SystemK&J Consulting20250—
+8K251735Stabilis SA Cervical Stand-Alone System (Various PNs)Acuity Surgical Devices, LLC20251—
+8K243816Testa TP Pivoting Spacer SystemSpine Wave, Inc.20250—
+8K243474MagnetOs MISKuros Biosciences B.V20250—
+8K250602X-PAC® N-GAGE™ Lumbar Plate SystemExpanding Innovations, Inc.20250—
+8K241783FortiVy™ OsteoVy™ Lumbar IBFVy Spine, LLC20250—
+8K243673Xenco Medical CancelleX Cervical Interbody SystemXenco Medical, LLC20250—
+8K242797OsteoFlo HydroFiberSurGenTec, LLC20241—
+8K242361OZARK Cervical Plate System; PYRENEES® Cervical Plate System; EVEREST® Spinal System…Stryker Spine20241—
+8K241077DeGen Medical Patient Specific Implant (PSI) SystemDegen Medical20242—
+8K233947KLIMT™ Expandable Lumbar Interbody Fusion (LIF) Cage SystemCtl Medical Corporation20240—
+8K233807LumiVy™ Lumbar IBF SystemVy Spine, LLC20241—
+8K232996Iatrical Interbody Lumbar Fusion Systems (Model ALIF, Model TLIF, Model LLIF)Shanghai Iatrical-Ti Technologies CO, Ltd.20240—
+8K241564Actifuse ABX; Actifuse MIS; Actifuse Shape; ALTAPORE; ALTAPORE SHAPE; ALTAPORE MISBaxter Healthcare Corporation20240—
+8K241212MagnetOs Easypack PuttyKuros Biosciences20241—
+8K241519Invictus® Small Stature Spinal Fixation SystemAlphatec Spine, Inc.20242—
+8K240625CORUS Navigation Access SystemProvidence Medical Technology, Inc.20244—
+8K233966Anterior Spine Truss System-Stand Alone (ASTS-SA)4Web Medical, Inc.20241—
+8K233509Zavation IBF System, Zavation Varisync Plate System and Varisync Spacer System…Zavation Medical Products, LLC20241—
+8K240715Idys® C ZP 3DTiClariance20240—
+8K240424Mineral Collagen Composite Bioactive Moldable Bone Graft MatrixCollagen Matrix, Inc.20240—
+8K240453ReBOSSISOrthorebirth Co., Ltd.202402
+8K233640Segmental Plating System (SPS);IdentiTi SPS Interbody System;IdentiTi NanoTec SPS…Alphatec Spine, Inc.20245—
+8K234013Mg OSTEOINJECT™; Mg OSTEOREVIVE™; Mg OSTEOCRETE™Bone Solutions, Inc.20243—
+8K231715MONDRIAN™ Anterior Lumbar Plate SystemCtl Medical Corporation20240—
+8K232877FaSet Fixation System, UNITY Sacroiliac Joint Fixation System, Huvex Interspinous…K&J Consulting Corporation20231—
+8K231743F3D Lateral Lumbar Interbody System, CL5 Lateral Lumbar Interbody System, and Oro…Corelink, LLC20233—
+8K230639Align Cervical Interbody Fusion SystemAcuity Surgical Devices, LLC20232—
+8K232348RIGEL™ 3DR Standalone Anterior Cervical Interbody Fusion SystemMiRus, LLC20231—
+8K232481RIGEL™ 3DR Anterior Cervical Corpectomy SystemMiRus, LLC20230—
+8K232822Peridot-TD Spacer system (The Peridot-TD Intervertebral body fusion system), Anterior…Gbs Commonwealth Co., Ltd.20232—
+8K231076VariLift®-C Interbody Fusion SystemWenzel Spine, Inc.20234—
+8K231739Cervical Spine Truss System (CSTS)4Web Medical, Inc.20232—
+8K232154MiRus 3DR Lateral Lumbar Interbody Fusion System with Integrated Plate FixationMiRus, LLC20230—
+8K231763Stable-C Interbody SystemNexus Spine, LLC20236—
+8K230329F3D Interbody SystemCorelink, LLC20230—
+8K230851Kodiak Lumbar Spacer SystemMet One Technologies, LLC20230—
+8K223513UniVy™ OsteoVy™-Ti Cervical IBF SystemVy Spine, LLC20231—
+8K223146EVOLUTION SPINE Interbody SystemEvolution Spine20239—
+8K220296Manta Ray TDF SpacerSeaSpine Orthopedics Corporation20231—
+8K221542Galileo Vertebral Body Replacement DeviceBright Spine20230—
+8K223412LumiVy™ Lumbar IBF SystemVy Spine, LLC20235—
+8K221926Invictus® Bone Cement, Invictus Spinal Fixation SystemAlphatec Spine, Inc.202214—
+8K223251Hexanium PLIFSpinevision, S.A.S.20220—
+8K223190Hive™ Standalone Cervical SystemNanoHive Medical, LLC20225—
+8K222009aprevo® anterior lumbar interbody fusion device with interfixationCarlsmed, Inc.202212—
+8K222903Tailored-H Cervical Stand Alone SystemBespoke Technologies, LLC20220—
+8K221578Hexanium ACIFSpinevision, S.A.S.20224—
+8K221719ABTross ALIF Expandable Cage SystemAegis Spine, Inc.20222—
+8K221936Standalone ALIF Interbody Fusion SystemEminent Spine20222—
+8K213417Ghost Spacer SystemLife Spine, Inc.20220—
+8K220953ChoiceSpine TigerShark™ M, Modular Interbody SystemChoice Spine, LLC20220—
+8K221403Cortera Spinal Fixation SystemSurgalign Spine Technologies202232
+8K222082aprevo® anterior and lateral lumbar interbody fusion devices, aprevo® transforaminal…Carlsmed, Inc.202211—
+8K212450Keos Anterior Cervical Interbody Fusion Device SystemKeos20220—
+8K220581Zavation eZspand Interbody SystemZavation Medical Products, LLC20224—
+8K220115ANTARES 3DR Standalone Anterior Lumbar Interbody Fusion SystemMiRus, LLC20220—
+8K211320CAPRI Corpectomy Cage SystemK2m, Inc.20222—
+8K211417F3D-C2 Cervical Stand-Alone SystemCorelink, LLC20223—
+8K212980Tesera-k ALIF SystemKyocera Medical Technologies, Inc.20222—
+8K212853Cervical Stand-Alone SystemEminent Spine, LLC202118—
+8K211449Triton™ Sacroiliac Joint Fixation SystemChoice Spine, LLC20211—
+8K211704CONSTRUX Mini PEEK Spacer System/CONSTRUX Mini PEEK VBR System, CONSTRUX Mini PTC Spacer…Orthofix, Inc.20215—
+8K210090Impulse AM Interbody Fusion SystemDegen Medical20217—
+8K210800IO Expandable Lumbar Interbody Fusion SystemMiRus, LLC20212—
+8K211388Lateral Spine Truss System (LSTS) Interbody Fusion Device4Web Medical, Inc.20210—
+8K210574NuVasive Pulse SystemNu Vasive, Incorporated202121
+8K210382Blustone Synergy Diamond SA Cervical SystemBlustone Synergy, LLC20210—
+8K211111SureMAX-SA Cervical Standalone SystemAdditive Implants, Inc.20218—
+8K210497SeaSpine Spacer System NM (Hollywood, Hollywood VI, Pacifica, Redondo, Ventura), Vu…SeaSpine Orthopedics Corporation202139—
+8K210595SPIRA-T Oblique Posterior Lumbar Spacers, SPIRA-P Posterior Lumbar SpacersCamber Spine Technologies, LLC20213—
+8K203311ChoiceSpine Blackhawk Ti Cervical Spacer SystemChoice Spine, LLC20213—