510(k) Report

Devices descending from K073291

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

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+7K193000Hexanium® ACIFSpinevision, S.A.S.202014—
+7K202327Invictus™ OsseoScrew® SystemAlphatec Spine, Inc.20200—
+7K202666CONSTRUX Mini PTC Spacer SystemOrthofix, Inc.202010—
+7K200958MODULIF-A Anterior Lumbar Interbody Fusion SystemSpinal Stability, LLC20200—
+7K200087F3D Cervical Stand-Alone Interbody Fusion SystemCorelink, LLC202025—
+7K200936Invictus™ CT Spinal Fixation SystemAlphatec Spine, Inc.20203—
+7K193636SeaSpine Reef TH SystemSeaSpine Orthopedics Corporation202056—
+7K200543NEXXT MATRIXX Stand Alone Cervical-Turn Lock (-TL) SystemNexxt Spine, LLC202072—
+7K193412NEXXT MATRIXX SystemNexxt Spine, LLC20201—
+7K193203MOJAVE Expandable Interbody SystemK2m, Inc.202015—
+7K192687TrellOss™-L MPFNexxt Spine, LLC20201—
+7K191822Nano FortiCore, FortiCoreNanovis, LLC20192—
+7K191339Zavation eZspand Interbody SystemZavation Medical Products, LLC20195—
+7K190870Cervical Spinal Truss System-Stand Alone (CSTS-SA)4Web, Inc.201910—
+7K191575ARx Spinal SystemLife Spine, Inc.201910—
+7K190680Favo S-TlifSilony Medical GmbH20190—
+7K183447EIT Cellular Titanium Lumbar Cage - T/PLIFEit Emerging Implant Technologies GmbH2019131—
+7K182114FlareHawk Interbody Fusion SystemIntegrity Implants, Inc.20196—
+7K180665SANTORINI Corpectomy Cage System, CAPRI Corpectomy Cage SystemK2m, LLC20189—
+7K181621Stable-C Interbody SystemNexus Spine, LLC20187—
+7K180777K2M Expandable Interbody SystemK2m, Inc.20180—
+7K172941CASCADIA Interbody SystemK2m201852—
+7K171893Blustone Synergy Lumbar Interbody Fusion System (Basalt, Magma, Obsidian), Blustone…Bluestone Synergy20172—
+7K171704CAPRI Corpectomy Cage SystemK2m201710—
+7K171097MOJAVE Expandable Interbody SystemK2m, Inc.201717—
+7K150788Talos Intervertebral Body Fusion Devices, Talos -C Cervical Intervertebral Body Fusion…Meditech Spine, LLC2015202—
+8K262489BluEX Cervical Expandable Cage SystemL&K BIOMED Co., Ltd.20260—
+8K261810Vertiwedge® Intraosseous SystemFoundation Surgical Group20260—
+8K253216IntraOp Alignment System; CONTOUR3D Bending SystemAlphatec Spine, Inc.20260—
+8K261279DeltaNEC Interbody SystemNexus Spine20260—
+8K253615Invictus Bands SystemAlphatec Spine, Inc.20260—
+8K253200Cervical Spine Truss System - Stand Alone (CSTS-SA)4Web Medical, Inc.20250—
+8K251522Mg OSTEOINJECT™; Mg OSTEOREVIVE™; Mg OSTEOCRETE™Bone Solutions, Inc.20251—
+8K243949OsteoFlo HydroFiberSurGenTec, LLC20250—
+8K243838NEXXT MATRIXX® SI SystemNexxt Spine20250—
+8K243673Xenco Medical CancelleX Cervical Interbody SystemXenco Medical, LLC20250—
+8K243835TiLink-P SI Joint Fusion SystemSurGenTec, LLC20240—
+8K242361OZARK Cervical Plate System; PYRENEES® Cervical Plate System; EVEREST® Spinal System…Stryker Spine20241—
+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—
+8K240893ARTFX MEDICAL Cervical PEEK CagesArtfx Medical20244—
+8K240951Invictus Robotic Navigation InstrumentsAlphatec Spine20242—
+8K233966Anterior Spine Truss System-Stand Alone (ASTS-SA)4Web Medical, Inc.20241—
+8K232877FaSet Fixation System, UNITY Sacroiliac Joint Fixation System, Huvex Interspinous…K&J Consulting Corporation20231—
+8K231836ClariVy™ Cervical IBF SystemVy Spine, LLC20232—
+8K232348RIGEL™ 3DR Standalone Anterior Cervical Interbody Fusion SystemMiRus, LLC20231—
+8K231494CoreLink Robotic Navigation InstrumentsCorelink, LLC20230—
+8K232481RIGEL™ 3DR Anterior Cervical Corpectomy SystemMiRus, LLC20230—
+8K232650KHEIRON® Spinal Fixation System, including patient specific K-RODS.M.A.I.O20236—
+8K231739Cervical Spine Truss System (CSTS)4Web Medical, Inc.20232—
+8K232413Fusion Robotic Navigation SystemAlphatec Spine, Inc.20232—
+8K231763Stable-C Interbody SystemNexus Spine, LLC20236—
+8K230026SqualeImplanet, S.A.20230—
+8K223671CONDUIT LLIF Straight InsertersEnztec Limited20231—
+8K223251Hexanium PLIFSpinevision, S.A.S.20220—
+8K221578Hexanium ACIFSpinevision, S.A.S.20224—
+8K221776NextGen Pedicle Screw SystemCorelink, LLC20222—
+8K220025ARx® Spinal SystemLife Spine, Inc.20220—
+8K211320CAPRI Corpectomy Cage SystemK2m, Inc.20222—
+8K213460Invictus Spinal Fixation SystemAlphatec Spine, Inc.202117—
+8K212853Cervical Stand-Alone SystemEminent Spine, LLC202118—
+8K202836GX Navigation Instrument SystemLife Spine, Inc.20211—
+8K210382Blustone Synergy Diamond SA Cervical SystemBlustone Synergy, LLC20210—
+8K211111SureMAX-SA Cervical Standalone SystemAdditive Implants, Inc.20218—
+8K193153SPIRA-C Integrated Fixation SystemCamber Spine Technologies20202—
+8K200070ARx Spinal SystemLife Spine, Inc.20209—
+8K191354Ti3Z Cervical Interbody SystemZavation Medical Products, LLC201913—
+8K170395Talos® Lumbar (HA) PEEK IBF DevicesMeditech Spine, LLC201710—
+8K160906Rampart O Lumbar Interbody Fusion Device, Rampart T Lumbar Interbody Fusion Device…Spineology, Inc.201627—
+9K260786KHEIRON® Spinal Fixation System, including patient specific K-RODS.M.A.I.O20261—
+9K253545Vulcan Spinal SystemK2m, Inc.20260—
+9K252711Advantage-C™ Ti3D Cervical Interbody Fusion DeviceIntelivation Technologies20260—
+9K253990KHEIRON® Spinal Fixation System, including patient specific K-RODS.M.A.I.O20262—
+9K253721KHEIRON® Spinal Fixation System, including patient specific K-RODS.M.A.I.O20252—
+9K253093Vital™ Spinal Fixation SystemHighridge Medical, LLC20250—
+9K251804KHEIRON® Spinal Fixation System, including patient specific K-RODS.M.A.I.O20254—
+9K251117Cervical Spine Truss System (CSTS)4Web Medical20250—
+9K250486Skyway Anterior Cervical Plate SystemKyocera Medical Technologies Inc. (KMTI)20251—
+9K243946EffortMed Spinal Fixation SystemEffortmed, LLC20251—
+9K232014CONDUIT™ ATP InsertersEnztec Limited20230—
+9K230608SPICCA Stand-Alone Cervical Fusion CagesSouthern Medical (Pty), Ltd.20230—
+9K223105Tesera-K SC SystemKyocera Medical Technologies, Inc.20225—
+9K220341ARx Modular Spinal SystemLife Spine, Inc.20221—
+9K210549ARx Spinal SystemLife Spine, Inc.20211—
+9K203163ARx Illiac Spinal Screw SystemLife Spine, Inc.20205—
+9K202305Zavation IBF SystemZavation Medical Products, LLC20209—
+9K181589Curiteva Lumbar Interbody Fusion SystemCuriteva, LLC20186—
+9K170643Interbody Fusion (IBF)/Vertebral Body Replacement (VBR) SystemRti Surgical, Inc. Dba Rti Biologics201711—
+9K163409Rampart (TM) T Lumbar Interbody Fusion DeviceSpineology, Inc.20170—
+9K162879Elite Expandable Interbody Fusion DeviceSpineology, Inc.20179—
+10K254247Osteomni Spinal Fixation SystemOsteomni, Inc.20260—
+10K242928Tesera-k SC SystemKyocera Medical Technologies, Inc.20250—
+10K233744Curiteva Porous PEEK Lumbar Interbody Fusion SystemCuriteva, Inc.20242—
+10K233455ARx MIS Spinal Screw SystemLife Spine, Inc.20230—
+10K211306LabyrinthZavation Medical Products, LLC20213—
+10K172343Fortilink® Interbody Fusion (IBF) System with TETRAfuse® 3D TechnologyRti Surgical, Inc.201710—
+10K171425Concorde LiftMedos International SARL201782
+11K213493Fortilink with TiPlus TechnologyParadigm Spine20220—
+11K190498Fortilink® IBF System with TETRAfuse®3D Technology, include the following designs…Pioneer Surgical Technology, Inc., Dba Rti Surgical, Inc.20197—