510(k) Report

Devices descending from K123045

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

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+6K243188Cylox® STSignus Medizintechnik GmbH20250—
+6K242372Mg OSTEOREVIVE™, Mg OSTEOCRETE™Bone Solutions, Inc.20242—
+6K232996Iatrical Interbody Lumbar Fusion Systems (Model ALIF, Model TLIF, Model LLIF)Shanghai Iatrical-Ti Technologies CO, Ltd.20240—
+6K241519Invictus® Small Stature Spinal Fixation SystemAlphatec Spine, Inc.20242—
+6K240699SCARLET® AC-TiSpineart SA20240—
+6K232792icotec Interbody Cage System (icotec Cervical Cage, icotec PLIF Lumbar Cage, icotec…Icotec AG20240—
+6K234150Lucent® XPSpinal Elements20240—
+6K233839Peridot-PT Anterior Cervical Intervertebral body fusion System; Peridot-PT…Gbs Commonwealth Co., Ltd.20231—
+6K232044Invictus Robotic Navigation InstrumentsAlphatec Spine, Inc.20233—
+6K232275Invictus® Spinal Fixation SystemAlphatec Spine, Inc.202311—
+6K231763Stable-C Interbody SystemNexus Spine, LLC20236—
+6K231241NanoHive Medical Lumbar Interbody SystemNanoHive Medical, LLC20230—
+6K230414ClariVy™ Cervical IBF SystemVy Spine, LLC20233—
+6K230721ATEC Lateral Plate SystemAlphatec Spine, Inc.20230—
+6K223418DeGen Impulse AM™ SystemDegen Medical20236—
+6K223174X-Pac Expandable LLIF Cage SystemExpanding Innovations, Inc.20233—
+6K223362Cervical Spine Truss System - Stand Alone (CSTS-SA) Interbody Fusion Device4Web Medical, Inc.20233—
+6K223474PathLoc-TA Expandable Lumbar Cage SystemL&K BIOMED Co., Ltd.20231—
+6K221266Cervical Spine Truss System (CSTS) Interbody Fusion Device4Web Medical, Inc.20233—
+6K220953ChoiceSpine TigerShark™ M, Modular Interbody SystemChoice Spine, LLC20220—
+6K221403Cortera Spinal Fixation SystemSurgalign Spine Technologies202232
+6K221049Zavation VariSync Plate System and VariSync Spacer SystemZavation Medical Products, LLC20226—
+6K212527Cervical Spine Truss System Plating Solution (CSTS-PS)4Web Medical, Inc.20220—
+6K212358Romero Cervical CageSpineup, Inc.20226—
+6K213951FORZA XP Expandable Spacer SystemOrthofix US, LLC20224—
+6K211449Triton™ Sacroiliac Joint Fixation SystemChoice Spine, LLC20211—
+6K210521DEXA-C Cervical Interbody SystemAurora Spine, Inc.20210—
+6K203311ChoiceSpine Blackhawk Ti Cervical Spacer SystemChoice Spine, LLC20213—
+6K201024Expandable Titanium PLIF/TLIF SystemSpectrum Spine, LLC20215—
+6K203576FORZA Ti Spacer SystemOrthofix, Inc.202161
+6K203327VERTACONNECT TLIF CageSignus Medizintechnik20210—
+6K202298Lucent XP, Lucent XP CurvedSpinal Elements, Inc.20202—
+6K203125Invictus™ OCT Spinal Fixation SystemAlphatec Spine, Inc.20200—
+6K203056Invictus™ Spinal Fixation SystemAlphatec Spine, Inc.202061—
+6K202327Invictus™ OsseoScrew® SystemAlphatec Spine, Inc.20200—
+6K202666CONSTRUX Mini PTC Spacer SystemOrthofix, Inc.202010—
+6K193172Luna XD Ti Interbody Fusion SystemBenvenue Medical, Inc.20201—
+6K200936Invictus™ CT Spinal Fixation SystemAlphatec Spine, Inc.20203—
+6K193636SeaSpine Reef TH SystemSeaSpine Orthopedics Corporation202056—
+6K191477AEON-C Stand Alone SystemHuvexel Co., Ltd.201910—
+6K191339Zavation eZspand Interbody SystemZavation Medical Products, LLC20195—
+6K190870Cervical Spinal Truss System-Stand Alone (CSTS-SA)4Web, Inc.201910—
+6K183243Velofix TLIF CageU&I Corporation20190—
+6K190546NEXXT MATRIXX Stand Alone Cervical SystemNexxt Spine, LLC201993—
+6K183588Choice Spine Hawkeye Vertebral Body Replacement (VBR) SystemChoicespine20195—
+6K182114FlareHawk Interbody Fusion SystemIntegrity Implants, Inc.20196—
+6K181921Solidity Vertebral Body ReplacementUlrich Medical USA20182—
+6K181829Velofix TLIF CageU&I Corporation20181—
+6K181229TirboLOX-C Cervical IBFDCaptiva Spine, Inc.20180—
+7K262828KHEIRON® Spinal Fixation System, including patient specific K-RODS.M.A.I.O20260—
+7K262489BluEX Cervical Expandable Cage SystemL&K BIOMED Co., Ltd.20260—
+7K253216IntraOp Alignment System; CONTOUR3D Bending SystemAlphatec Spine, Inc.20260—
+7K253615Invictus Bands SystemAlphatec Spine, Inc.20260—
+7K254045CarboClear® Posterior Cervical Screw System; CarboClear® Hybrid Posterior Cervical Screw…CarboFix Orthopedics, Ltd.20260—
+7K253200Cervical Spine Truss System - Stand Alone (CSTS-SA)4Web Medical, Inc.20250—
+7K251003X-PAC® LLIF Expandable Lateral Cage SystemExpanding Innovations, Inc.20250—
+7K243915FIX-C 3D Ti ACIF SystemJeil Medical Corporation20250—
+7K243739AxCess® Expandable Interbody SystemElliquence, LLC20250—
+7K241892Cortera™ Spinal Fixation SystemXtant Medical Holdings, Inc.20242—
+7K240893ARTFX MEDICAL Cervical PEEK CagesArtfx Medical20244—
+7K240951Invictus Robotic Navigation InstrumentsAlphatec Spine20242—
+7K233966Anterior Spine Truss System-Stand Alone (ASTS-SA)4Web Medical, Inc.20241—
+7K231836ClariVy™ Cervical IBF SystemVy Spine, LLC20232—
+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—
+7K230026SqualeImplanet, S.A.20230—
+7K223140AEON-C™ Stand Alone SystemDio Medical, Inc.20222—
+7K211785CASSATT™ SIJ Fixation SystemCtl Medical Corporation20220—
+7K213460Invictus Spinal Fixation SystemAlphatec Spine, Inc.202117—
+7K203342CONSTRUX Mini Ti Spacer SystemOrthofix, Inc.202191
+7K202637F3D Corpectomy SystemCorelink, LLC20201—
+7K193000Hexanium® ACIFSpinevision, S.A.S.202014—
+7K200087F3D Cervical Stand-Alone Interbody Fusion SystemCorelink, LLC202025—
+7K200235KONG-TL VBR System, KONG-C VBR SystemIcotec AG20201—
+7K193153SPIRA-C Integrated Fixation SystemCamber Spine Technologies20202—
+7K192145Galileo Vertebral Body Replacement DeviceBright Spine20201—
+7K200543NEXXT MATRIXX Stand Alone Cervical-Turn Lock (-TL) SystemNexxt Spine, LLC202072—
+8K253894BMD Titanium Spinal Fusion SystemGlobal Biomedica s.r.o.20260—
+8K251117Cervical Spine Truss System (CSTS)4Web Medical20250—
+8K243946EffortMed Spinal Fixation SystemEffortmed, LLC20251—
+8K243015Skyway Anterior Cervical Plate SystemKyocera Medical Technologies, Inc.20242—
+8K232790KONG®-TL VBR System and KONG® C VBR SystemIcotec AG20240—
+8K232877FaSet Fixation System, UNITY Sacroiliac Joint Fixation System, Huvex Interspinous…K&J Consulting Corporation20231—
+8K232348RIGEL™ 3DR Standalone Anterior Cervical Interbody Fusion SystemMiRus, LLC20231—
+8K222015Integral Titanium Cervical InterbodyNvision Biomedical Technologies, Inc.20231—
+8K221542Galileo Vertebral Body Replacement DeviceBright Spine20230—
+8K221578Hexanium ACIFSpinevision, S.A.S.20224—
+8K212853Cervical Stand-Alone SystemEminent Spine, LLC202118—
+8K211111SureMAX-SA Cervical Standalone SystemAdditive Implants, Inc.20218—
+9K254247Osteomni Spinal Fixation SystemOsteomni, Inc.20260—
+9K250486Skyway Anterior Cervical Plate SystemKyocera Medical Technologies Inc. (KMTI)20251—
+9K243673Xenco Medical CancelleX Cervical Interbody SystemXenco Medical, LLC20250—
+9K230608SPICCA Stand-Alone Cervical Fusion CagesSouthern Medical (Pty), Ltd.20230—
+9K223105Tesera-K SC SystemKyocera Medical Technologies, Inc.20225—
+10K242928Tesera-k SC SystemKyocera Medical Technologies, Inc.20250—