510(k) Report

Devices descending from K020152

1,684 later devices reach Synthes Vertebral Spacer TI through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+7K100037Advanced Vertebral Solutions Express BFDAdvanced Vertebral Solutions, LLC20100—
+7K100210TRANS1 Lateral Intervertebral Fusion Device, TTrans1 Incorporated2010175—
+7K100820Wenzel Spine Varilift Interbody Fusion SystemWenzel Spine201016—
+7K100544Impix Lumbar Interbody DeviceMedicrea Technologies201001
+7K101302Aleutian Ibf SystemK2m, Inc.2010595—
+7K100043Coroent XLR Standalone SystemNuvasive, Inc.2010744—
+7K091301Life Spine Stand-Alone Spacer SystemLife Spine2009473—
+7K080401Shell Cage, Wave Cage, Loop CageAdvanced Medical Technologies AG2008840—
+7K073291Capstone Spinal SystemMedtronic Sofamor Danek USA, Inc.20081,103—
+7K080083Intrepid Spinal SystemMedtronic Sofamor Danek20089328
+7K073502Vertebron VBR SystemVertebron, Inc.200812—
+8K262595VariLift-C Cervical Interbody Fusion SystemWenzel Spine, Inc.20260—
+8K261809Interwedge® Standalone LateralFoundation Surgical Group20260—
+8K2530413d Cage CervicalFims Co., Ltd.20260—
+8K261060Navigated LLIF Impactable TrackerTyber Medical, LLC20260—
+8K253894BMD Titanium Spinal Fusion SystemGlobal Biomedica s.r.o.20260—
+8K261067BEE PLIF CageNGMedical GmbH20260—
+8K260549ZSFab Cervical Interbody System and ZSFab Lumbar Interbody SystemZsfab, Inc.20260—
+8K254274ARx® SAI Implant SystemLife Spine, Inc.20260—
+8K252774Uni-C Cervical Cage SystemZheJiang Decans Medical Devices Co., Ltd.20260—
+8K252432Flex-Z™ Cervical CageSpinepoint, LLC20260—
+8K253559Ventana™ A Anterior Lumbar Interbody SystemSpinal Elements, Inc.20260—
+8K253545Vulcan Spinal SystemK2m, Inc.20260—
+8K253748Life Spine ProLift & ProLift Lateral and ProLift Lateral Fixated Expandable Spacer SystemLife Spine, Inc.20260—
+8K253266Titanium Interbody SystemSpine Innovation, LLC20260—
+8K251829DeGen Medical Patient Specific Implant (PSI) SystemDegen Medical20250—
+8K252322SIros-X SystemGenesys Spine20250—
+8K253094iFuse Bedrock Granite Implant SystemSI-BONE, Inc.20250—
+8K243116FlareHawk Interbody Fusion SystemIntegrity Implants Inc. Dba Accelus20250—
+8K242928Tesera-k SC SystemKyocera Medical Technologies, Inc.20250—
+8K250521NanoBone® SBX Putty ; NanoBone® QDBiocomposites, Ltd.20250—
+8K250186GoLIF! Lumbar Interbody Fusion SystemGetset Surgical, SA20250—
+8K250556Porous Biologic ScaffoldVentris Medical20250—
+8K243706Mastergraft Matrix EXT; Mastergraft Strip; Mastergraft Putty; Mastergraft GranulesMedtronic Sofamor Danek, Inc.20250—
+8K243670Idys® LIFClariance20240—
+8K241167BioSphere Putty; BioSphere MIS PuttySynergy Biomedical20240—
+8K242361OZARK Cervical Plate System; PYRENEES® Cervical Plate System; EVEREST® Spinal System…Stryker Spine20241—
+8K243007CD Horizon™ Spinal SystemMedtronic Sofamor Danek USA, Inc.20243—
+8K242267Gemini Medical Cage SystemZheJiang Decans Medical Devices Co., Ltd.20241—
+8K242826ProLift Wedge Expandable Spacer SystemLife Spine, Inc.20240—
+8K242457EARP Interbody SystemRetropsoas Technologies, LLC20240—
+8K242299NovaBone Putty - Synthetic Bioactive Bone GraftNovabone Products, LLC20241—
+8K242273Cove Putty, OsteoCove PuttySeaSpine Orthopedics Corporation202402
+8K232996Iatrical Interbody Lumbar Fusion Systems (Model ALIF, Model TLIF, Model LLIF)Shanghai Iatrical-Ti Technologies CO, Ltd.20240—
+8K242069Eminent Spine Scoliosis Deformity Pedicle Screw SystemEminent Spine20240—
+8K241464ARx® SAI Implant SystemLife Spine, Inc.20241—
+8K240442MagnetOs PuttyKuros Biosciences B.V20243—
+8K240507NuVasive AttraX ScaffoldNuvasive, Inc.20240—
+8K233359DOMINION Expandable Corpectomy SystemAstura Medical20242—
+8K240458Synthetic Bone PuttyVentris Medical20242—
+8K240459Cerament Bone Void FillerBonesupport AB20240—
+8K232347MagnetOs GranulesKuros Biosciences B.V20242—
+8K233839Peridot-PT Anterior Cervical Intervertebral body fusion System; Peridot-PT…Gbs Commonwealth Co., Ltd.20231—
+8K233607MagnetOs Easypack PuttyKuros Biosciences B.V20232—
+8K233490SIGNAFUSE Bioactive Strip (SBS); SIGNAFUSE PuttyBioventus, LLC20232—
+8K233245MagnetOs Flex MatrixKuros Biosciences B.V20230—
+8K230927OptiMesh Multiplanar Expandable Interbody Fusion SystemSpineology, Inc.20231—
+8K232044Invictus Robotic Navigation InstrumentsAlphatec Spine, Inc.20233—
+8K232275Invictus® Spinal Fixation SystemAlphatec Spine, Inc.202311—
+8K231739Cervical Spine Truss System (CSTS)4Web Medical, Inc.20232—
+8K232315Catalyst Bone Void FillerOssdsign AB20237—
+8K222988neoWave LS Lumbar Straight, neoWave C Cervical, and Ti3D CervicalHt Medical D.B.A. Xenix Medical20232—
+8K232150ZSFab Cervical Interbody SystemZsfab, Inc.20234—
+8K231735NuVasive CoRoent Small Interbody System; NuVasive CoRoent Small Contoured Interbody…Nu Vasive, Incorporated20239—
+8K231252Ventana™ L Spinal SystemSpinal Elements, Inc.20231—
+8K223143SAGICO Spinal SystemSagico VA USA, LLC20230—
+8K230721ATEC Lateral Plate SystemAlphatec Spine, Inc.20230—
+8K222004INTEGRATE -C Interbody Fusion SystemHappe Spine20236—
+8K223868PYXIS 3D Titanium Cage SystemGS Medical Co., Ltd.20232—
+8K223776PEEK Spinal Infusion CageChangzhou Geasure Medical Apparatus and Instruments Co., Ltd.20230—
+8K222041CYGNUS-C Standalone ACIF SystemGS Medical Co., Ltd.20231—
+8K223362Cervical Spine Truss System - Stand Alone (CSTS-SA) Interbody Fusion Device4Web Medical, Inc.20233—
+8K221266Cervical Spine Truss System (CSTS) Interbody Fusion Device4Web Medical, Inc.20233—
+8K223251Hexanium PLIFSpinevision, S.A.S.20220—
+8K223510Matrix HA Fusion Porous Cervical IBF SystemInnovasis, Inc.20220—
+8K221182Southern Transforaminal Lumbar Interbody Fusion (TLIF)Southern Medical (Pty), Ltd.20220—
+8K221578Hexanium ACIFSpinevision, S.A.S.20224—
+8K222276CONDUIT Cages; FIBERGRAFT BG PuttyDepuy Spine202229—
+8K221858ZSFab Lumbar Interbody SystemZsfab, Inc.20224—
+8K221646CD HORIZON™ ASTUTE™ SPINAL SYSTEM; CD HORIZON™ Growth Rod Conversion Set; CD HORIZON™…Medtronic Sofamor Danek USA, Inc.202220—
+8K213641MONDRIAN ALIF Cage with Supplementary Fixation PlateCtl Medical Corporation20221—
+8K220875HAcancellous PEEK-C Porous HA PEEK Cervical IBF SystemInnovasis, Inc.20224—
+8K221325CONDUIT Lateral Switch PlateMedos International SARL20221—
+8K220696uCerv Flux-C 3D Porous Titanium Cervical InterbodyUlrich Medical USA20221—
+8K221844TDM Lumbar Interbody Fusion Cage SystemTdm Co., Ltd.20221—
+8K213791Unispace SA Cervical CageEdisoninno Co., Ltd.20222—
+8K212527Cervical Spine Truss System Plating Solution (CSTS-PS)4Web Medical, Inc.20220—
+8K213420WaveForm L System, WaveForm TO System, WaveForm TA SystemSeaSpine Orthopedics Corporation202211—
+8K212477EARP Interbody SystemNvision Biomedical Technologies, Inc.20221—
+8K212358Romero Cervical CageSpineup, Inc.20226—
+8K212266FIX-C PEEK Anterior Cervical Interbody SystemJeil Medical Corporation20217—
+8K210573Velofix SA Cervical CageU&I Corporation20211—
+8K212653Catalyft LS Expandable Interbody SystemMedtronic Sofamor Danek USA, Inc.202127
+8K211845Deploy Expandable Interbody SystemSouthern Spine, LLC20210—
+8K212520ProLift Micro Expandable Spacer SystemLife Spine, Inc.20216—
+8K211740DualXAmplify Surgical, Inc.20211—
+8K211474Kleiner KG2 SystemBAAT Medical Products B.V.20210—
+8K212540Explorer TO SystemSeaSpine Orthopedics Corporation20213—
+8K212070KMTI S141 Lumbar Interbody Fusion SystemKyocera Medical Technologies, Inc.20210—
+8K211413BEE PLIF CageNGMedical GmbH20211—