510(k) Report

Devices descending from K123045

696 later devices reach Brigade Standalone System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+5K233947KLIMT™ Expandable Lumbar Interbody Fusion (LIF) Cage SystemCtl Medical Corporation20240—
+5K233807LumiVy™ Lumbar IBF SystemVy Spine, LLC20241—
+5K241564Actifuse ABX; Actifuse MIS; Actifuse Shape; ALTAPORE; ALTAPORE SHAPE; ALTAPORE MISBaxter Healthcare Corporation20240—
+5K241464ARx® SAI Implant SystemLife Spine, Inc.20241—
+5K241321Juliet® Ti LL Lumbar Interbody DeviceSpineart SA20240—
+5K241413sagAlign Lumbar Cage System (Various PNs)Acuity Surgical Devices, LLC20240—
+5K241467Stable-C Interbody SystemNexus Spine, LLC20242—
+5K241212MagnetOs Easypack PuttyKuros Biosciences20241—
+5K241466Shoreline ACS Interbody System; Shoreline RT Interbody System; Regatta Lateral System…SeaSpine Orthopedics Corporation20243—
+5K240721ExcelsiusFlex™Globus Medical, Inc.20240—
+5K240749PILLAR SA Ti Spacer System (82-XXX)Orthofix, Inc.202402
+5K240715Idys® C ZP 3DTiClariance20240—
+5K233375Tranquil-L Interbody SystemNexus Spine, LLC20240—
+5K231850QUARTEX® Occipito-Cervico-Thoracic Spinal System ExcelsiusGPS® InstrumentsGlobus Medical, Inc.20242—
+5K240424Mineral Collagen Composite Bioactive Moldable Bone Graft MatrixCollagen Matrix, Inc.20240—
+5K240416Tranquil-C Interbody SystemNexus Spine, LLC20243—
+5K240453ReBOSSISOrthorebirth Co., Ltd.202402
+5K233640Segmental Plating System (SPS);IdentiTi SPS Interbody System;IdentiTi NanoTec SPS…Alphatec Spine, Inc.20245—
+5K234013Mg OSTEOINJECT™; Mg OSTEOREVIVE™; Mg OSTEOCRETE™Bone Solutions, Inc.20243—
+5K231715MONDRIAN™ Anterior Lumbar Plate SystemCtl Medical Corporation20240—
+5K231743F3D Lateral Lumbar Interbody System, CL5 Lateral Lumbar Interbody System, and Oro…Corelink, LLC20233—
+5K230639Align Cervical Interbody Fusion SystemAcuity Surgical Devices, LLC20232—
+5K232822Peridot-TD Spacer system (The Peridot-TD Intervertebral body fusion system), Anterior…Gbs Commonwealth Co., Ltd.20232—
+5K231076VariLift®-C Interbody Fusion SystemWenzel Spine, Inc.20234—
+5K232154MiRus 3DR Lateral Lumbar Interbody Fusion System with Integrated Plate FixationMiRus, LLC20230—
+5K222874CarboClear Cervical Cage System, CarboClear Cervical VBR SystemCarbofix Orthpedics, Ltd.20230—
+5K231252Ventana™ L Spinal SystemSpinal Elements, Inc.20231—
+5K223513UniVy™ OsteoVy™-Ti Cervical IBF SystemVy Spine, LLC20231—
+5K230583Tryptik TiSpineart SA20231—
+5K223231Ti-Largo Cervical Interbody SystemFlospine20230—
+5K220296Manta Ray TDF SpacerSeaSpine Orthopedics Corporation20231—
+5K223412LumiVy™ Lumbar IBF SystemVy Spine, LLC20235—
+5K221926Invictus® Bone Cement, Invictus Spinal Fixation SystemAlphatec Spine, Inc.202214—
+5K223190Hive™ Standalone Cervical SystemNanoHive Medical, LLC20225—
+5K222903Tailored-H Cervical Stand Alone SystemBespoke Technologies, LLC20220—
+5K222732WaveForm A Interbody SystemSeaSpine Orthopedics Corporation20229—
+5K221719ABTross ALIF Expandable Cage SystemAegis Spine, Inc.20222—
+5K212450Keos Anterior Cervical Interbody Fusion Device SystemKeos20220—
+5K220581Zavation eZspand Interbody SystemZavation Medical Products, LLC20224—
+5K212811Ti3Z Lumbar Interbody SystemZavation Medical Products, LLC20223—
+5K213355Toro-L Interbody Fusion SystemIntegrity Implants, Inc.20224—
+5K211704CONSTRUX Mini PEEK Spacer System/CONSTRUX Mini PEEK VBR System, CONSTRUX Mini PTC Spacer…Orthofix, Inc.20215—
+5K210090Impulse AM Interbody Fusion SystemDegen Medical20217—
+5K210800IO Expandable Lumbar Interbody Fusion SystemMiRus, LLC20212—
+5K211388Lateral Spine Truss System (LSTS) Interbody Fusion Device4Web Medical, Inc.20210—
+5K210155Duo Expandable Interbody Fusion SystemSpineology, Inc.20210—
+5K202398Ti3Z Cervical Interbody SystemZavation Medical Products, LLC20219—
+5K203153CREO Stabilization System, Navigation Instruments, ExcelsiusGPSGlobus Medical, Inc.20211—
+5K202495SIRION Lateral Lumbar Interbody FusionAstura Medical, LLC20216—
+5K201643ChoiceSpine Tiger Shark Cervical Spacer SystemChoice Spine, LLC20204—
+5K201287Impulse Interbody Fusion SystemDegen Medical20208—
+5K202812IdentiTi Cervical Standalone Interbody SystemAlphatec Spine, Inc.202067—
+5K202587ATEC Lateral Interbody SystemAlphatec Spine, Inc.202039—
+5K202198FlareHawk Interbody Fusion SystemIntegrity Implants, Inc.20202—
+5K201367FlareHawk TiHawk9 Interbody Fusion SystemIntegrity Implants, Inc.20202—
+5K201073Seaspine WaveForm C Interbody SystemSeaSpine Orthopedics Corporation202017—
+5K201646Shoreline ACS (Anterior Cervical System)SeaSpine Orthopedics Corporation202020—
+5K201500Life Spine Plateau-A Ti Anterior Lumbar Spacer & Plateau-X Ti Lateral Lumbar SpacerLife Spine, Inc.20203—
+5K200685RIGEL 3DR Anterior Cervical Interbody Fusion SystemMiRus, LLC20200—
+5K200052CONSTRUX Mini PTC Spacer System, FORZA PTC Spacer System, PILLAR SA PTC Spacer SystemOrthofix, Inc.202013—
+5K200312Tryptik TiSpineart20202—
+5K192006SIRION Lateral Lumbar Interbody SystemAstura Medical, LLC202014—
+5K192897icotec Cervical CageIcotec AG20201—
+5K192938Invictus™ Spinal Fixation SystemAlphatec Spine, Inc.201969—
+5K192132SeaSpine Beachside SystemSeaSpine Orthopedics Corporation2019591
+5K1803473d CageFims Co., Ltd.20190—
+5K192214CarboClear VBR SystemCarboFix Orthopedics, Ltd.20191—
+5K191621ChoiceSpine Octane A/T/P Spinal Implant System, ChoiceSpine Cervical Interbody Spacer…Choice Spine, LLC20194—
+5K190291Addivation Medical Cervical Interbody SystemAddivation Medical, LLC20190—
+5K190889Republic Spine Restore Cervical Interbody Fusion SystemRepublic Spine, LLC20190—
+5K183560Luna 3D GEN2 Interbody Fusion SystemBenvenue Medical, Inc.20192—
+5K183092Kuros TLIF CageKuros Biosciences B.V20190—
+5K182584Lucent® XPSpinal Elements, Inc.20183—
+5K181837Spinal Elements Ti-Bond coated devicesSpinal Elements, Inc.201898—
+5K181621Stable-C Interbody SystemNexus Spine, LLC20187—
+5K180990TirboLOX-L Lumbar IBFDCaptiva Spine, Inc.20181—
+5K180777K2M Expandable Interbody SystemK2m, Inc.20180—
+5K180364HD LifeSciences Cervical IBFD SystemHd Lifesciences, LLC2018106—
+5K180675Atlas Spine Expandable Cervical Interbody SystemAtlas Spine, Inc.20182—
+5K172816TiGer Shark™ SystemChoicespine, LP201859—
+5K172696FORZA® XP Expandable Spacer SystemOrthofix, Inc.201825—
+5K173159Cervical Spinal Truss System (CSTS) Interbody Fusion Device4Web, Inc.201812—
+5K172419Velofix™ TLIF CageU&I Corporation20172—
+5K171686Choice Spine Hawkeye™ Vertebral Body Replacement (VBR) SystemChoicespine2017116—
+6K263172SAS MIS Pelvic Incidence RodsSpinal Alignment Solutions, Inc.20260—
+6K262595VariLift-C Cervical Interbody Fusion SystemWenzel Spine, Inc.20260—
+6K261205SPINEART Navigation Instrument SystemSpineart SA20260—
+6K254130C.A. Medical Interbody Fusion SystemC.A. Medical, LLC20260—
+6K253802KHEIRON® Spinal Fixation System, including patient specific K-RODS.M.A.I.O20261—
+6K261279DeltaNEC Interbody SystemNexus Spine20260—
+6K261060Navigated LLIF Impactable TrackerTyber Medical, LLC20260—
+6K260840BluEX Cervical Expandable Cage SystemL&K BIOMED Co., Ltd.20261—
+6K260850Osteomni Spinal Cages SystemOsteomni, Inc.20260—
+6K260385aprevo® anterior and lateral lumbar interbody system; aprevo® posterior and…Carlsmed, Inc.20260—
+6K253739SCRIPT™ Rods, CREO™ Stabilization System, REVERE® Stabilization System, REVERE® 4.5…Globus Medical, Inc.20260—
+6K251829DeGen Medical Patient Specific Implant (PSI) SystemDegen Medical20250—
+6K252327CMORE® CT System; CMORE® CT System Navigated InstrumentsIcotec AG20251—
+6K251522Mg OSTEOINJECT™; Mg OSTEOREVIVE™; Mg OSTEOCRETE™Bone Solutions, Inc.20251—
+6K251965Proximity Anterior Cervical Plate System; Segmental Plating System (SPS)Alphatec Spine, Inc.20250—
+6K243949OsteoFlo HydroFiberSurGenTec, LLC20250—