510(k) Report

Devices descending from K103731

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

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+7K221719ABTross ALIF Expandable Cage SystemAegis Spine, Inc.20222—
+7K221388NuVasive Reline Cervical SystemNu Vasive, Incorporated20220—
+7K221403Cortera Spinal Fixation SystemSurgalign Spine Technologies202232
+7K213791Unispace SA Cervical CageEdisoninno Co., Ltd.20222—
+7K220449DePuy CONDUIT LLIF SQUID InserterEnztec Limited20220—
+7K211320CAPRI Corpectomy Cage SystemK2m, Inc.20222—
+7K212980Tesera-k ALIF SystemKyocera Medical Technologies, Inc.20222—
+7K212088Integrity Implants Navigated InstrumentsIntegrity Implants, Inc.20210—
+7K212853Cervical Stand-Alone SystemEminent Spine, LLC202118—
+7K212823DePuy CONDUIT LLIF Angled InsertersEnztec Limited20213—
+7K211449Triton™ Sacroiliac Joint Fixation SystemChoice Spine, LLC20211—
+7K211413BEE PLIF CageNGMedical GmbH20211—
+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—
+7K210728CONDUIT InstrumentsMedos International SARL20215—
+7K210539CoreLink Midline Fixation SystemCorelink, LLC20214—
+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—
+7K203367LineSider™ Spinal SystemIntegrity Implants, Inc.202054
+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—
+7K192132SeaSpine Beachside SystemSeaSpine Orthopedics Corporation2019591
+7K1803473d CageFims Co., Ltd.20190—
+7K191354Ti3Z Cervical Interbody SystemZavation Medical Products, LLC201913—
+7K191575ARx Spinal SystemLife Spine, Inc.201910—
+7K191565Endoskeleton TCS Interbody Fusion DeviceTitan Spine, Inc.201901
+7K190680Favo S-TlifSilony Medical GmbH20190—
+7K183588Choice Spine Hawkeye Vertebral Body Replacement (VBR) SystemChoicespine20195—
+7K181921Solidity Vertebral Body ReplacementUlrich Medical USA20182—
+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—
+8K260850Osteomni Spinal Cages SystemOsteomni, Inc.20260—
+8K253615Invictus Bands SystemAlphatec Spine, Inc.20260—
+8K253545Vulcan Spinal SystemK2m, Inc.20260—
+8K252711Advantage-C™ Ti3D Cervical Interbody Fusion DeviceIntelivation Technologies20260—
+8K250769Dakota LP SystemPrecision Spine, Inc.20250—
+8K252351UniSpace® TPLIF CageCg Medtech Co., Ltd.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—
+8K243838NEXXT MATRIXX® SI SystemNexxt Spine20250—
+8K243915FIX-C 3D Ti ACIF SystemJeil Medical Corporation20250—
+8K243835TiLink-P SI Joint Fusion SystemSurGenTec, LLC20240—
+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—
+8K234119UniSpace® Stand-Alone C CageInnosys Co., Ltd.20241—
+8K232790KONG®-TL VBR System and KONG® C VBR SystemIcotec AG20240—
+8K233839Peridot-PT Anterior Cervical Intervertebral body fusion System; Peridot-PT…Gbs Commonwealth Co., Ltd.20231—
+8K231494CoreLink Robotic Navigation InstrumentsCorelink, LLC20230—
+8K232650KHEIRON® Spinal Fixation System, including patient specific K-RODS.M.A.I.O20236—
+8K232413Fusion Robotic Navigation SystemAlphatec Spine, Inc.20232—
+8K230608SPICCA Stand-Alone Cervical Fusion CagesSouthern Medical (Pty), Ltd.20230—
+8K230414ClariVy™ Cervical IBF SystemVy Spine, LLC20233—
+8K223474PathLoc-TA Expandable Lumbar Cage SystemL&K BIOMED Co., Ltd.20231—
+8K223671CONDUIT LLIF Straight InsertersEnztec Limited20231—
+8K223105Tesera-K SC SystemKyocera Medical Technologies, Inc.20225—
+8K211785CASSATT™ SIJ Fixation SystemCtl Medical Corporation20220—
+8K221776NextGen Pedicle Screw SystemCorelink, LLC20222—
+8K220025ARx® Spinal SystemLife Spine, Inc.20220—
+8K212358Romero Cervical CageSpineup, Inc.20226—
+8K213460Invictus Spinal Fixation SystemAlphatec Spine, Inc.202117—
+8K212967AxTiHA Stand-Alone ALIF SystemInnovasis, Inc.20211—
+8K212540Explorer TO SystemSeaSpine Orthopedics Corporation20213—
+8K202836GX Navigation Instrument SystemLife Spine, Inc.20211—
+8K202305Zavation IBF SystemZavation Medical Products, LLC20209—
+8K193636SeaSpine Reef TH SystemSeaSpine Orthopedics Corporation202056—
+8K200070ARx Spinal SystemLife Spine, Inc.20209—
+8K181229TirboLOX-C Cervical IBFDCaptiva Spine, Inc.20180—
+9K260786KHEIRON® Spinal Fixation System, including patient specific K-RODS.M.A.I.O20261—
+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—
+9K242928Tesera-k SC SystemKyocera Medical Technologies, Inc.20250—
+9K250486Skyway Anterior Cervical Plate SystemKyocera Medical Technologies Inc. (KMTI)20251—
+9K250603AxTiHA® Stand-Alone ALIF SystemInnovasis20250—
+9K243946EffortMed Spinal Fixation SystemEffortmed, LLC20251—
+9K242829BluEX Lumbar Expandable Cage SystemL&K BIOMED Co., Ltd.20240—
+9K240893ARTFX MEDICAL Cervical PEEK CagesArtfx Medical20244—
+9K231836ClariVy™ Cervical IBF SystemVy Spine, LLC20232—
+9K232014CONDUIT™ ATP InsertersEnztec Limited20230—