510(k) Report

Devices descending from K121760

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

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+7K231715MONDRIAN™ Anterior Lumbar Plate SystemCtl Medical Corporation20240—
+7K233839Peridot-PT Anterior Cervical Intervertebral body fusion System; Peridot-PT…Gbs Commonwealth Co., Ltd.20231—
+7K232877FaSet Fixation System, UNITY Sacroiliac Joint Fixation System, Huvex Interspinous…K&J Consulting Corporation20231—
+7K231743F3D Lateral Lumbar Interbody System, CL5 Lateral Lumbar Interbody System, and Oro…Corelink, LLC20233—
+7K230639Align Cervical Interbody Fusion SystemAcuity Surgical Devices, LLC20232—
+7K232348RIGEL™ 3DR Standalone Anterior Cervical Interbody Fusion SystemMiRus, LLC20231—
+7K232481RIGEL™ 3DR Anterior Cervical Corpectomy SystemMiRus, LLC20230—
+7K232822Peridot-TD Spacer system (The Peridot-TD Intervertebral body fusion system), Anterior…Gbs Commonwealth Co., Ltd.20232—
+7K232044Invictus Robotic Navigation InstrumentsAlphatec Spine, Inc.20233—
+7K231076VariLift®-C Interbody Fusion SystemWenzel Spine, Inc.20234—
+7K232275Invictus® Spinal Fixation SystemAlphatec Spine, Inc.202311—
+7K231739Cervical Spine Truss System (CSTS)4Web Medical, Inc.20232—
+7K223869ChoiceSpine Blackhawk Ti Cervical Spacer SystemChoice Spine, LLC20232—
+7K231766Skyway Anterior Cervical Plate SystemKyocera Medical Technologies Inc. (KMTI)20233—
+7K231763Stable-C Interbody SystemNexus Spine, LLC20236—
+7K230329F3D Interbody SystemCorelink, LLC20230—
+7K230851Kodiak Lumbar Spacer SystemMet One Technologies, LLC20230—
+7K230721ATEC Lateral Plate SystemAlphatec Spine, Inc.20230—
+7K223146EVOLUTION SPINE Interbody SystemEvolution Spine20239—
+7K220296Manta Ray TDF SpacerSeaSpine Orthopedics Corporation20231—
+7K221542Galileo Vertebral Body Replacement DeviceBright Spine20230—
+7K223412LumiVy™ Lumbar IBF SystemVy Spine, LLC20235—
+7K223671CONDUIT LLIF Straight InsertersEnztec Limited20231—
+7K223251Hexanium PLIFSpinevision, S.A.S.20220—
+7K223190Hive™ Standalone Cervical SystemNanoHive Medical, LLC20225—
+7K222903Tailored-H Cervical Stand Alone SystemBespoke Technologies, LLC20220—
+7K221578Hexanium ACIFSpinevision, S.A.S.20224—
+7K221719ABTross ALIF Expandable Cage SystemAegis Spine, Inc.20222—
+7K221936Standalone ALIF Interbody Fusion SystemEminent Spine20222—
+7K211785CASSATT™ SIJ Fixation SystemCtl Medical Corporation20220—
+7K221403Cortera Spinal Fixation SystemSurgalign Spine Technologies202232
+7K212450Keos Anterior Cervical Interbody Fusion Device SystemKeos20220—
+7K220581Zavation eZspand Interbody SystemZavation Medical Products, LLC20224—
+7K211320CAPRI Corpectomy Cage SystemK2m, Inc.20222—
+7K211417F3D-C2 Cervical Stand-Alone SystemCorelink, LLC20223—
+7K212980Tesera-k ALIF SystemKyocera Medical Technologies, Inc.20222—
+7K212853Cervical Stand-Alone SystemEminent Spine, LLC202118—
+7K211704CONSTRUX Mini PEEK Spacer System/CONSTRUX Mini PEEK VBR System, CONSTRUX Mini PTC Spacer…Orthofix, Inc.20215—
+7K210800IO Expandable Lumbar Interbody Fusion SystemMiRus, LLC20212—
+7K211388Lateral Spine Truss System (LSTS) Interbody Fusion Device4Web Medical, Inc.20210—
+7K210574NuVasive Pulse SystemNu Vasive, Incorporated202121
+7K210382Blustone Synergy Diamond SA Cervical SystemBlustone Synergy, LLC20210—
+7K211111SureMAX-SA Cervical Standalone SystemAdditive Implants, Inc.20218—
+7K210497SeaSpine Spacer System NM (Hollywood, Hollywood VI, Pacifica, Redondo, Ventura), Vu…SeaSpine Orthopedics Corporation202139—
+7K210595SPIRA-T Oblique Posterior Lumbar Spacers, SPIRA-P Posterior Lumbar SpacersCamber Spine Technologies, LLC20213—
+7K203520Blustone Synergy Interbody Fusion SystemBlustone Synergy, LLC20210—
+7K210155Duo Expandable Interbody Fusion SystemSpineology, Inc.20210—
+7K202637F3D Corpectomy SystemCorelink, LLC20201—
+7K201287Impulse Interbody Fusion SystemDegen Medical20208—
+7K202812IdentiTi Cervical Standalone Interbody SystemAlphatec Spine, Inc.202067—
+7K203125Invictus™ OCT Spinal Fixation SystemAlphatec Spine, Inc.20200—
+7K203056Invictus™ Spinal Fixation SystemAlphatec Spine, Inc.202061—
+7K202198FlareHawk Interbody Fusion SystemIntegrity Implants, Inc.20202—
+7K202327Invictus™ OsseoScrew® SystemAlphatec Spine, Inc.20200—
+7K201367FlareHawk TiHawk9 Interbody Fusion SystemIntegrity Implants, Inc.20202—
+7K201614TxTiHA IBF System, AxTiHA Stand-Alone ALIF SystemInnovasis, Inc.2020471
+7K200685RIGEL 3DR Anterior Cervical Interbody Fusion SystemMiRus, LLC20200—
+7K200235KONG-TL VBR System, KONG-C VBR SystemIcotec AG20201—
+7K200936Invictus™ CT Spinal Fixation SystemAlphatec Spine, Inc.20203—
+7K193153SPIRA-C Integrated Fixation SystemCamber Spine Technologies20202—
+7K193418SeaSpine Skipjack SystemSeaSpine Orthopedics Corporation20204—
+7K182987Genesys Spine 3DP Lumbar Interbody SystemGenesys Spine20199—
+7K192132SeaSpine Beachside SystemSeaSpine Orthopedics Corporation2019591
+7K1803473d CageFims Co., Ltd.20190—
+7K191354Ti3Z Cervical Interbody SystemZavation Medical Products, LLC201913—
+7K191565Endoskeleton TCS Interbody Fusion DeviceTitan Spine, Inc.201901
+7K190680Favo S-TlifSilony Medical GmbH20190—
+7K180990TirboLOX-L Lumbar IBFDCaptiva Spine, Inc.20181—
+8K262025Innovasis AxTiHA® Stand-Alone ALIF System;Innovasis TxTiHA® IBF System;Innovasis…INNO Holdings Inc. DBA Innovasis20260—
+8K262595VariLift-C Cervical Interbody Fusion SystemWenzel Spine, Inc.20260—
+8K253216IntraOp Alignment System; CONTOUR3D Bending SystemAlphatec Spine, Inc.20260—
+8K260329Ion-C Navigation InstrumentsSurGenTec, LLC20261—
+8K260850Osteomni Spinal Cages SystemOsteomni, Inc.20260—
+8K253615Invictus Bands SystemAlphatec Spine, Inc.20260—
+8K254045CarboClear® Posterior Cervical Screw System; CarboClear® Hybrid Posterior Cervical Screw…CarboFix Orthopedics, Ltd.20260—
+8K253545Vulcan Spinal SystemK2m, Inc.20260—
+8K252711Advantage-C™ Ti3D Cervical Interbody Fusion DeviceIntelivation Technologies20260—
+8K250769Dakota LP SystemPrecision Spine, Inc.20250—
+8K251522Mg OSTEOINJECT™; Mg OSTEOREVIVE™; Mg OSTEOCRETE™Bone Solutions, Inc.20251—
+8K250076Endeavor™ Stand-Alone Cervical IBF SystemInnovasis20250—
+8K251965Proximity Anterior Cervical Plate System; Segmental Plating System (SPS)Alphatec Spine, Inc.20250—
+8K243949OsteoFlo HydroFiberSurGenTec, LLC20250—
+8K251117Cervical Spine Truss System (CSTS)4Web Medical20250—
+8K243659FLASH™ Facet Fusion Instruments, IsoTis® Facet Fusion InstrumentsSeaSpine Orthopedics Corporation20250—
+8K243015Skyway Anterior Cervical Plate SystemKyocera Medical Technologies, Inc.20242—
+8K242372Mg OSTEOREVIVE™, Mg OSTEOCRETE™Bone Solutions, Inc.20242—
+8K241892Cortera™ Spinal Fixation SystemXtant Medical Holdings, Inc.20242—
+8K240951Invictus Robotic Navigation InstrumentsAlphatec Spine20242—
+8K232256Alcantara Thoracolumbar Plate SystemCamber Spine Technologies, LLC20240—
+8K232790KONG®-TL VBR System and KONG® C VBR SystemIcotec AG20240—
+8K232014CONDUIT™ ATP InsertersEnztec Limited20230—
+8K230608SPICCA Stand-Alone Cervical Fusion CagesSouthern Medical (Pty), Ltd.20230—
+8K230414ClariVy™ Cervical IBF SystemVy Spine, LLC20233—
+8K230989Rod Registration FrameNu Vasive, Incorporated20230—
+8K221324ENZA-O Titanium Lateral Anterior Lumbar Interbody Fusion (ALIF)Camber Spine Technologies20230—
+8K223174X-Pac Expandable LLIF Cage SystemExpanding Innovations, Inc.20233—
+8K223474PathLoc-TA Expandable Lumbar Cage SystemL&K BIOMED Co., Ltd.20231—
+8K223105Tesera-K SC SystemKyocera Medical Technologies, Inc.20225—
+8K220096Genesys Spine 3DP Lumbar Interbody SystemGenesys Spine20220—
+8K212358Romero Cervical CageSpineup, Inc.20226—