510(k) Report

Devices descending from K073291

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

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+6K191621ChoiceSpine Octane A/T/P Spinal Implant System, ChoiceSpine Cervical Interbody Spacer…Choice Spine, LLC20194—
+6K191553NuVaisve® Reline® Cervical SystemNu Vasive, Incorporated20192—
+6K191565Endoskeleton TCS Interbody Fusion DeviceTitan Spine, Inc.201901
+6K190291Addivation Medical Cervical Interbody SystemAddivation Medical, LLC20190—
+6K190360LineSider™ Spinal SystemIntegrity Implants, Inc.201913—
+6K190546NEXXT MATRIXX Stand Alone Cervical SystemNexxt Spine, LLC201993—
+6K183092Kuros TLIF CageKuros Biosciences B.V20190—
+6K190055Duo Lumbar Interbody Fusion DeviceSpineology, Inc.20191—
+6K182974NuVasive Reline SystemNu Vasive, Incorporated201911—
+6K182477Cervical SpacerAdditive Implants, LLC201915—
+6K182322Duo Lumbar Interbody Fusion DeviceSpineology, Inc.20182—
+6K181229TirboLOX-C Cervical IBFDCaptiva Spine, Inc.20180—
+6K181014Tritanium PL CageStryker Spine2018137—
+6K180963Roccia Alif, Roccia TlifSilony Medical GmbH20183—
+6K180364HD LifeSciences Cervical IBFD SystemHd Lifesciences, LLC2018106—
+6K180675Atlas Spine Expandable Cervical Interbody SystemAtlas Spine, Inc.20182—
+6K171495Zyston Strut Open Titanium Spacer SystemZimmer Biomet Spine, Inc.20181—
+6K173025NuVasive® MLX® – Medial Lateral Expandable Lumbar Interbody System; NuVasive® AP…Nu Vasive, Incorporated20188—
+6K171312FortiCore®Nanovis, LLC20183—
+6K172696FORZA® XP Expandable Spacer SystemOrthofix, Inc.201825—
+6K173159Cervical Spinal Truss System (CSTS) Interbody Fusion Device4Web, Inc.201812—
+6K172253Altus Spine Cervical Interbody Fusion SystemAltus Partners, LLC20170—
+6K171140Matrixx SystemNexxt Spine, LLC2017145—
+6K170399Endoskeleton TO Interbody Fusion Device (IBD)Titan Spine, LLC2017105—
+6K170961NuVasive CoRoent Small Interlock II SystemNu Vasive, Incorporated201718—
+6K170055CAPRI Corpectomy Cage SystemK2m201711—
+6K163364MOJAVE Expandable Interbody SystemK2m201725—
+6K162264Cascadia Interbody SystemK2m, Inc.2016169—
+6K143163AVS® AL and ALign PEEK Spacers, AVS® PL and UniLIF PEEK Spacers, AVS® TL PEEK Spacer…Stryker Corporation2015636—
+7K262025Innovasis AxTiHA® Stand-Alone ALIF System;Innovasis TxTiHA® IBF System;Innovasis…INNO Holdings Inc. DBA Innovasis20260—
+7K262230Mg OSTEOREVIVE™;Mg OSTEOCRETE™Bone Solutions, Inc.20260—
+7K262595VariLift-C Cervical Interbody Fusion SystemWenzel Spine, Inc.20260—
+7K253894BMD Titanium Spinal Fusion SystemGlobal Biomedica s.r.o.20260—
+7K260840BluEX Cervical Expandable Cage SystemL&K BIOMED Co., Ltd.20261—
+7K260850Osteomni Spinal Cages SystemOsteomni, Inc.20260—
+7K261067BEE PLIF CageNGMedical GmbH20260—
+7K252834Sacroiliac Joint Truss System (SJTS)4Web Medical20260—
+7K251302OptiMesh Multiplanar Expandable Interbody Fusion SystemSpineology, Inc.20250—
+7K250769Dakota LP SystemPrecision Spine, Inc.20250—
+7K253147FIBERGRAFT™ BG Putty GPS Bone Graft Substitute FIBERGRAFT™ BG Putty Bone Graft…Prosidyan, Inc.20250—
+7K242827A8 INTEGR8™ Porous Pedicle ScrewsAllumin8, Inc.20251—
+7K251479Mobarn 80:20 Lumbar Interbody Fusion System (Posterior Lumbar Interbody Fusion Cage…Mobarn Medical Devices, LLC20250—
+7K251965Proximity Anterior Cervical Plate System; Segmental Plating System (SPS)Alphatec Spine, Inc.20250—
+7K251003X-PAC® LLIF Expandable Lateral Cage SystemExpanding Innovations, Inc.20250—
+7K243474MagnetOs MISKuros Biosciences B.V20250—
+7K243934Stable-L Lumbar Interbody SystemNexus Spine, LLC20250—
+7K243188Cylox® STSignus Medizintechnik GmbH20250—
+7K242797OsteoFlo HydroFiberSurGenTec, LLC20241—
+7K242414TiLink-P Joint Fusion SystemSurGenTec, LLC20240—
+7K241468Vertiwedge® Intraosseous SystemFoundation Surgical Group, Inc.20241—
+7K242141TiLink-P SI Joint Fusion SystemSurGenTec, LLC20241—
+7K241738PYXIS 3D Titanium Cervical Cage systemGS Medical Co., Ltd.20241—
+7K241564Actifuse ABX; Actifuse MIS; Actifuse Shape; ALTAPORE; ALTAPORE SHAPE; ALTAPORE MISBaxter Healthcare Corporation20240—
+7K241467Stable-C Interbody SystemNexus Spine, LLC20242—
+7K241574iFuse TORQ® Implant SystemSI-BONE, Inc.20244—
+7K241212MagnetOs Easypack PuttyKuros Biosciences20241—
+7K241519Invictus® Small Stature Spinal Fixation SystemAlphatec Spine, Inc.20242—
+7K232792icotec Interbody Cage System (icotec Cervical Cage, icotec PLIF Lumbar Cage, icotec…Icotec AG20240—
+7K232790KONG®-TL VBR System and KONG® C VBR SystemIcotec AG20240—
+7K240424Mineral Collagen Composite Bioactive Moldable Bone Graft MatrixCollagen Matrix, Inc.20240—
+7K240416Tranquil-C Interbody SystemNexus Spine, LLC20243—
+7K240453ReBOSSISOrthorebirth Co., Ltd.202402
+7K234013Mg OSTEOINJECT™; Mg OSTEOREVIVE™; Mg OSTEOCRETE™Bone Solutions, Inc.20243—
+7K231443Mini-OSTEO Pedicle Fixation SystemOsteomed Indústria E Comércio DE Implantes Ltda20230—
+7K233084Peridot-PT Anterior Cervical Intervertebral body fusion System, Peridot-PT…Gbs Commonwealth Co., Ltd.20232—
+7K232044Invictus Robotic Navigation InstrumentsAlphatec Spine, Inc.20233—
+7K232275Invictus® Spinal Fixation SystemAlphatec Spine, Inc.202311—
+7K230226Integrity-SI® Fusion SystemOsteoCentric Technologies20230—
+7K223869ChoiceSpine Blackhawk Ti Cervical Spacer SystemChoice Spine, LLC20232—
+7K231766Skyway Anterior Cervical Plate SystemKyocera Medical Technologies Inc. (KMTI)20233—
+7K231098LineSider® Spinal SystemIntegrity Implants, Inc.20233—
+7K222015Integral Titanium Cervical InterbodyNvision Biomedical Technologies, Inc.20231—
+7K230414ClariVy™ Cervical IBF SystemVy Spine, LLC20233—
+7K230721ATEC Lateral Plate SystemAlphatec Spine, Inc.20230—
+7K223362Cervical Spine Truss System - Stand Alone (CSTS-SA) Interbody Fusion Device4Web Medical, Inc.20233—
+7K221542Galileo Vertebral Body Replacement DeviceBright Spine20230—
+7K223181NuVasive Reline SystemNu Vasive, Incorporated202311—
+7K221266Cervical Spine Truss System (CSTS) Interbody Fusion Device4Web Medical, Inc.20233—
+7K223140AEON-C™ Stand Alone SystemDio Medical, Inc.20222—
+7K221162UniVy OsteoVy Cervical IBF SystemVy Spine, LLC20222—
+7K221388NuVasive Reline Cervical SystemNu Vasive, Incorporated20220—
+7K221403Cortera Spinal Fixation SystemSurgalign Spine Technologies202232
+7K220449DePuy CONDUIT LLIF SQUID InserterEnztec Limited20220—
+7K212527Cervical Spine Truss System Plating Solution (CSTS-PS)4Web Medical, Inc.20220—
+7K202266Reliance Cervical IBF SystemReliance Medical Systems, LLC20223—
+7K212358Romero Cervical CageSpineup, Inc.20226—
+7K213951FORZA XP Expandable Spacer SystemOrthofix US, LLC20224—
+7K212088Integrity Implants Navigated InstrumentsIntegrity Implants, Inc.20210—
+7K212823DePuy CONDUIT LLIF Angled InsertersEnztec Limited20213—
+7K212967AxTiHA Stand-Alone ALIF SystemInnovasis, Inc.20211—
+7K211413BEE PLIF CageNGMedical GmbH20211—
+7K210521DEXA-C Cervical Interbody SystemAurora Spine, Inc.20210—
+7K210728CONDUIT InstrumentsMedos International SARL20215—
+7K210539CoreLink Midline Fixation SystemCorelink, LLC20214—
+7K203342CONSTRUX Mini Ti Spacer SystemOrthofix, Inc.202191
+7K210359Hexanium TLIFSpinevision, S.A.S.20211—
+7K203125Invictus™ OCT Spinal Fixation SystemAlphatec Spine, Inc.20200—
+7K203367LineSider™ Spinal SystemIntegrity Implants, Inc.202054
+7K203056Invictus™ Spinal Fixation SystemAlphatec Spine, Inc.202061—
+7K202949CONSTRUX Mini PEEK Spacer SystemOrthofix, Inc.20206—