510(k) Report

Devices descending from K170318

49 later devices reach NeoFuse Ti3D PLIF/TLIF/Cervical Interbody through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K222988neoWave LS Lumbar Straight, neoWave C Cervical, and Ti3D CervicalHt Medical D.B.A. Xenix Medical20232—
+1K200458Tailored-C Cervical Interbody Fusion SystemBespoke Technologies20203—
+1K192115SABLE Expandable SpacerGlobus Medical, Inc.202037—
+1K182210TiWAVE-L Porous Titanium Lumbar CageKalitec Medical, LLC20193—
+1K180401TiWAVE-C™ Porous Titanium Cervical CageKalitec Direct, LLC20185—
+2K261049Scala® TLSpineart SA20260—
+2K260837VersaLift Expandable SystemLife Spine, Inc.20260—
+2K252240Spectrum Spine Cervical Cage System; Spectrum Spine Lumbar Cage SystemSpectrum Spine20260—
+2K253583LUX Expandable Lumbar Interbody SystemXenix Medical20260—
+2K233947KLIMT™ Expandable Lumbar Interbody Fusion (LIF) Cage SystemCtl Medical Corporation20240—
+2K234035COSINE™ SpacerGlobus Medical, Inc.20240—
+2K233191TotalTi ACDF by SAGICOSpinal Analytics & Geometrical Implant Co, LLC20230—
+2K230607SPICCA Cervical Fusion CagesSouthern Medical (Pty), Ltd.20230—
+2K221138Titus Titanium Cervical by SAGICOSagico VA USA, LLC20231—
+2K221894Lumbar Expandable lnterbody Spacers -Additional Indications/ImplantsGlobus Medical, Inc.20232—
+2K222903Tailored-H Cervical Stand Alone SystemBespoke Technologies, LLC20220—
+2K222270HEDRON Cervical Spacers, HEDRON Lumbar Spacers, SABLE Expandable Spacer, ExcelsiusGPS…Globus Medical, Inc.202223—
+2K212450Keos Anterior Cervical Interbody Fusion Device SystemKeos20220—
+2K220581Zavation eZspand Interbody SystemZavation Medical Products, LLC20224—
+2K210800IO Expandable Lumbar Interbody Fusion SystemMiRus, LLC20212—
+2K210214NuVasive Modulus Expandable Posterior Lumbar MOD-EX PL Interbody SystemNu Vasive, Incorporated20213—
+3K253401SCRIPT™ Implant SystemGlobus Medical, Inc.20260—
+3K253876HEDRON™ Cervical Spacers (HEDRON C-MIS™ Spacer)Globus Medical, Inc.20251—
+3K250599ExcelsiusGPS™ InstrumentsGlobus Medical, Inc.20250—
+3K252737DeGen Medical Latitude-C AM Cervical Interbody Fusion SystemDegen Medical20250—
+3K243635aprevo® anterior lumbar interbody fusion device with interfixationCarlsmed, Inc.20245—
+3K241846E3D™-C Interbody SystemEvolution Spine20246—
+3K234077SPIRA® Anterior Lumbar SpacersCamber Spine Technologies20240—
+3K232292Peridot-EX Expandable Intervertebral Body Fusion SystemGbs Commonwealth Co., Ltd.20230—
+3K231241NanoHive Medical Lumbar Interbody SystemNanoHive Medical, LLC20230—
+3K231199Solar Lumbar Interbody Fusion SystemDegen Medical20235—
+3K223837SPIRA®-C Integrated Fixation SystemCamber Spine Technologies20230—
+3K223174X-Pac Expandable LLIF Cage SystemExpanding Innovations, Inc.20233—
+4K261882Pisces-SC Standalone Cervical Interbody SystemOsseus Fusions Systems, LLC20260—
+4K262094E3D™-C Interbody SystemEvolution Spine20260—
+4K260036NeckTune™ 3D SA Cervical CageMedyssey Co, Ltd.20260—
+4K254105Hive™ Standalone Cervical System and Hive™ C Interbody SystemNanoHive Medical, LLC20260—
+4K260038E3D™-C Interbody SystemEvolution Spine20261—
+4K252894aprevo® cervical interbody systemCarlsmed, Inc.20261—
+4K251003X-PAC® LLIF Expandable Lateral Cage SystemExpanding Innovations, Inc.20250—
+4K251617X-PAC® TLIF Expandable Posterior Cage System; X-PAC® LLIF Expandable Lateral Cage SystemExpanding Innovations, Inc.20250—
+4K250602X-PAC® N-GAGE™ Lumbar Plate SystemExpanding Innovations, Inc.20250—
+4K243802aprevo® anterior and lateral lumbar interbody fusion device, aprevo® anterior lumbar…Carlsmed, Inc.20253—
+4K240326Solar™ Lumbar Interbody Fusion SystemDegen Medical, Inc.20244—
+5K260385aprevo® anterior and lateral lumbar interbody system; aprevo® posterior and…Carlsmed, Inc.20260—
+5K250827aprevo® anterior lumbar interbody fusion device; aprevo® lateral lumbar interbody fusion…Carlsmed, Inc.20252—
+5K241077DeGen Medical Patient Specific Implant (PSI) SystemDegen Medical20242—
+6K250667DeGen Medical Patient Specific Implant (PSI) SystemDegen Medical20251—
+7K251829DeGen Medical Patient Specific Implant (PSI) SystemDegen Medical20250—