510(k) Report

Devices descending from K083714

412 later devices reach Endoskeleton TT Interbody Fusion Device (Ibd) through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+6K222383Anteralign™ LS Spinal System with Titan nanoLOCK™ Surface Technology MAZORX Stealth (TM)…Medtronic Sofamor Danek USA, Inc.20220—
+6K220953ChoiceSpine TigerShark™ M, Modular Interbody SystemChoice Spine, LLC20220—
+6K221403Cortera Spinal Fixation SystemSurgalign Spine Technologies202232
+6K213791Unispace SA Cervical CageEdisoninno Co., Ltd.20222—
+6K220449DePuy CONDUIT LLIF SQUID InserterEnztec Limited20220—
+6K220581Zavation eZspand Interbody SystemZavation Medical Products, LLC20224—
+6K220115ANTARES 3DR Standalone Anterior Lumbar Interbody Fusion SystemMiRus, LLC20220—
+6K220711SeaSpine Meridian System, SeaSpine Meridian Anterior Plate SystemSeaSpine Orthopedics Corporation202210—
+6K212811Ti3Z Lumbar Interbody SystemZavation Medical Products, LLC20223—
+6K220453FlareHawk Interbody Fusion SystemIntegrity Implants, Inc.20221—
+6K212980Tesera-k ALIF SystemKyocera Medical Technologies, Inc.20222—
+6K212823DePuy CONDUIT LLIF Angled InsertersEnztec Limited20213—
+6K211449Triton™ Sacroiliac Joint Fixation SystemChoice Spine, LLC20211—
+6K212070KMTI S141 Lumbar Interbody Fusion SystemKyocera Medical Technologies, Inc.20210—
+6K211413BEE PLIF CageNGMedical GmbH20211—
+6K210583SeaSpine WaveForm™ A Interbody SystemSeaSpine Orthopedics Corporation202114—
+6K210728CONDUIT InstrumentsMedos International SARL20215—
+6K201671A-Link ZAcuity Surgical Devices, LLC202125—
+6K203342CONSTRUX Mini Ti Spacer SystemOrthofix, Inc.202191
+6K210155Duo Expandable Interbody Fusion SystemSpineology, Inc.20210—
+6K202820Australis Anterior Lumbar Cage SystemPrism Surgical Designs Pty, Ltd.20200—
+6K202812IdentiTi Cervical Standalone Interbody SystemAlphatec Spine, Inc.202067—
+6K203125Invictus™ OCT Spinal Fixation SystemAlphatec Spine, Inc.20200—
+6K203056Invictus™ Spinal Fixation SystemAlphatec Spine, Inc.202061—
+6K202198FlareHawk Interbody Fusion SystemIntegrity Implants, Inc.20202—
+6K202327Invictus™ OsseoScrew® SystemAlphatec Spine, Inc.20200—
+6K201939GAIA Lumbar Interbody Fusion Device (LIFD) FamilyPrinterprezz20200—
+6K201367FlareHawk TiHawk9 Interbody Fusion SystemIntegrity Implants, Inc.20202—
+6K200936Invictus™ CT Spinal Fixation SystemAlphatec Spine, Inc.20203—
+6K183243Velofix TLIF CageU&I Corporation20190—
+6K183397ChoiceSpine Stealth Cervical Spacer SystemChoicespine, LP201916—
+6K183588Choice Spine Hawkeye Vertebral Body Replacement (VBR) SystemChoicespine20195—
+6K181921Solidity Vertebral Body ReplacementUlrich Medical USA20182—
+6K181829Velofix TLIF CageU&I Corporation20181—
+6K180519HARRIER-SA™ Lumbar Interbody SystemChoicespine, LP20180—
+7K262595VariLift-C Cervical Interbody Fusion SystemWenzel Spine, Inc.20260—
+7K261882Pisces-SC Standalone Cervical Interbody SystemOsseus Fusions Systems, LLC20260—
+7K261284Invictus® Small Stature Spinal Fixation System; Invictus® 2.0 Spinal Fixation SystemAlphatec Spine, Inc.20260—
+7K254130C.A. Medical Interbody Fusion SystemC.A. Medical, LLC20260—
+7K261279DeltaNEC Interbody SystemNexus Spine20260—
+7K260036NeckTune™ 3D SA Cervical CageMedyssey Co, Ltd.20260—
+7K261060Navigated LLIF Impactable TrackerTyber Medical, LLC20260—
+7K260549ZSFab Cervical Interbody System and ZSFab Lumbar Interbody SystemZsfab, Inc.20260—
+7K254274ARx® SAI Implant SystemLife Spine, Inc.20260—
+7K253615Invictus Bands SystemAlphatec Spine, Inc.20260—
+7K254017SWINGO-3D Lumbar Cage SystemImplanet20260—
+7K251829DeGen Medical Patient Specific Implant (PSI) SystemDegen Medical20250—
+7K252351UniSpace® TPLIF CageCg Medtech Co., Ltd.20250—
+7K252322SIros-X SystemGenesys Spine20250—
+7K251522Mg OSTEOINJECT™; Mg OSTEOREVIVE™; Mg OSTEOCRETE™Bone Solutions, Inc.20251—
+7K253094iFuse Bedrock Granite Implant SystemSI-BONE, Inc.20250—
+7K251735Stabilis SA Cervical Stand-Alone System (Various PNs)Acuity Surgical Devices, LLC20251—
+7K243949OsteoFlo HydroFiberSurGenTec, LLC20250—
+7K243116FlareHawk Interbody Fusion SystemIntegrity Implants Inc. Dba Accelus20250—
+7K243386Ventris Intervertebral Body Fusion DeviceAcuity Surgical Devices, LLC20252—
+7K241783FortiVy™ OsteoVy™ Lumbar IBFVy Spine, LLC20250—
+7K243915FIX-C 3D Ti ACIF SystemJeil Medical Corporation20250—
+7K243007CD Horizon™ Spinal SystemMedtronic Sofamor Danek USA, Inc.20243—
+7K242372Mg OSTEOREVIVE™, Mg OSTEOCRETE™Bone Solutions, Inc.20242—
+7K241892Cortera™ Spinal Fixation SystemXtant Medical Holdings, Inc.20242—
+7K241464ARx® SAI Implant SystemLife Spine, Inc.20241—
+7K234119UniSpace® Stand-Alone C CageInnosys Co., Ltd.20241—
+7K233694Meridian Interbody System; WaveForm A Interbody SystemSeaSpine Orthopedics Corporation20248—
+7K233839Peridot-PT Anterior Cervical Intervertebral body fusion System; Peridot-PT…Gbs Commonwealth Co., Ltd.20231—
+7K232044Invictus Robotic Navigation InstrumentsAlphatec Spine, Inc.20233—
+7K232275Invictus® Spinal Fixation SystemAlphatec Spine, Inc.202311—
+7K222015Integral Titanium Cervical InterbodyNvision Biomedical Technologies, Inc.20231—
+7K230721ATEC Lateral Plate SystemAlphatec Spine, Inc.20230—
+7K223174X-Pac Expandable LLIF Cage SystemExpanding Innovations, Inc.20233—
+7K223671CONDUIT LLIF Straight InsertersEnztec Limited20231—
+7K222732WaveForm A Interbody SystemSeaSpine Orthopedics Corporation20229—
+7K211785CASSATT™ SIJ Fixation SystemCtl Medical Corporation20220—
+7K222561AlignAcuity Surgical Devices, LLC202214—
+7K220523restor3d TiDAL Lumbar Interbody Fusion DeviceRestor3D20222—
+7K220610SOLO-LAurora Spine, Inc.20220—
+7K212358Romero Cervical CageSpineup, Inc.20226—
+7K213460Invictus Spinal Fixation SystemAlphatec Spine, Inc.202117—
+7K202398Ti3Z Cervical Interbody SystemZavation Medical Products, LLC20219—
+7K202637F3D Corpectomy SystemCorelink, LLC20201—
+7K201643ChoiceSpine Tiger Shark Cervical Spacer SystemChoice Spine, LLC20204—
+7K200235KONG-TL VBR System, KONG-C VBR SystemIcotec AG20201—
+7K192145Galileo Vertebral Body Replacement DeviceBright Spine20201—
+7K190889Republic Spine Restore Cervical Interbody Fusion SystemRepublic Spine, LLC20190—
+8K253802KHEIRON® Spinal Fixation System, including patient specific K-RODS.M.A.I.O20261—
+8K253216IntraOp Alignment System; CONTOUR3D Bending SystemAlphatec Spine, Inc.20260—
+8K252781MSFX Mikron Peek CagesMikron Makina Sanayi VE Tic. Ltd. Sti.20251—
+8K251003X-PAC® LLIF Expandable Lateral Cage SystemExpanding Innovations, Inc.20250—
+8K251459OneLIF™ Interbody Fusion SystemNovapproach Spine, LLC20250—
+8K250602X-PAC® N-GAGE™ Lumbar Plate SystemExpanding Innovations, Inc.20250—
+8K243673Xenco Medical CancelleX Cervical Interbody SystemXenco Medical, LLC20250—
+8K243946EffortMed Spinal Fixation SystemEffortmed, LLC20251—
+8K240893ARTFX MEDICAL Cervical PEEK CagesArtfx Medical20244—
+8K240951Invictus Robotic Navigation InstrumentsAlphatec Spine20242—
+8K232790KONG®-TL VBR System and KONG® C VBR SystemIcotec AG20240—
+8K234087restor3d TIDAL Lumbar Interbody Fusion SystemRestor3D20240—
+8K232014CONDUIT™ ATP InsertersEnztec Limited20230—
+8K230329F3D Interbody SystemCorelink, LLC20230—
+8K223326Axiom PSR SystemRestor3D202301
+8K230026SqualeImplanet, S.A.20230—
+8K221542Galileo Vertebral Body Replacement DeviceBright Spine20230—