510(k) Report

Devices descending from K153627

252 later devices reach NuVasive® TLX Interbody System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+5K251502TruLift® Lateral Expandable Spacer & Lateral Buttress Plate SystemLife Spine, Inc.20250—
+5K250827aprevo® anterior lumbar interbody fusion device; aprevo® lateral lumbar interbody fusion…Carlsmed, Inc.20252—
+5K251644ProAM ALIF SystemPro Surgical, Inc.20250—
+5K250845Curiteva Porous PEEK Standalone ALIF SystemCuriteva, Inc.20251—
+5K250669Adaptix™ Interbody System with Titan nanoLOCK™ Surface TechnologyMedtronic Sofamor Danek USA, Inc.20250—
+5K250521NanoBone® SBX Putty ; NanoBone® QDBiocomposites, Ltd.20250—
+5K243074Spectrum Spine Lumbar Cage SystemSpectrum Spine, Inc.20252—
+5K250556Porous Biologic ScaffoldVentris Medical20250—
+5K241783FortiVy™ OsteoVy™ Lumbar IBFVy Spine, LLC20250—
+5K243802aprevo® anterior and lateral lumbar interbody fusion device, aprevo® anterior lumbar…Carlsmed, Inc.20253—
+5K243706Mastergraft Matrix EXT; Mastergraft Strip; Mastergraft Putty; Mastergraft GranulesMedtronic Sofamor Danek, Inc.20250—
+5K241167BioSphere Putty; BioSphere MIS PuttySynergy Biomedical20240—
+5K242517ProAM ACDF SystemPro Surgical, Inc.20240—
+5K241487Interwedge® Standalone LateralFoundation Surgical Group, Inc.20241—
+5K242299NovaBone Putty - Synthetic Bioactive Bone GraftNovabone Products, LLC20241—
+5K242273Cove Putty, OsteoCove PuttySeaSpine Orthopedics Corporation202402
+5K242509HAnano InterFuse (R) Modular InterbodyNext Orthosurgical20240—
+5K241846E3D™-C Interbody SystemEvolution Spine20246—
+5K240326Solar™ Lumbar Interbody Fusion SystemDegen Medical, Inc.20244—
+5K234077SPIRA® Anterior Lumbar SpacersCamber Spine Technologies20240—
+5K241519Invictus® Small Stature Spinal Fixation SystemAlphatec Spine, Inc.20242—
+5K240830Reef TO/TA System; Regatta Lateral System; Explorer TO System; WaveForm C Interbody…Orthofix Medical, Inc.20242—
+5K240838Spectrum Spine Cervical Cage SystemSpectrum Spine, Inc.20244—
+5K240566Reef L Interbody System; WaveForm L Interbody SystemSeaSpine Orthopedics Corporation20245—
+5K240442MagnetOs PuttyKuros Biosciences B.V20243—
+5K240507NuVasive AttraX ScaffoldNuvasive, Inc.20240—
+5K240458Synthetic Bone PuttyVentris Medical20242—
+5K240459Cerament Bone Void FillerBonesupport AB20240—
+5K233640Segmental Plating System (SPS);IdentiTi SPS Interbody System;IdentiTi NanoTec SPS…Alphatec Spine, Inc.20245—
+5K233735ADIRA™ Lateral Plate SystemGlobus Medical, Inc.20240—
+5K232347MagnetOs GranulesKuros Biosciences B.V20242—
+5K233607MagnetOs Easypack PuttyKuros Biosciences B.V20232—
+5K231743F3D Lateral Lumbar Interbody System, CL5 Lateral Lumbar Interbody System, and Oro…Corelink, LLC20233—
+5K233490SIGNAFUSE Bioactive Strip (SBS); SIGNAFUSE PuttyBioventus, LLC20232—
+5K233245MagnetOs Flex MatrixKuros Biosciences B.V20230—
+5K230927OptiMesh Multiplanar Expandable Interbody Fusion SystemSpineology, Inc.20231—
+5K231486Stable-L Standalone Lumbar Interbody SystemNexus Spine, LLC20231—
+5K232530Stable-L Standalone Lumbar Interbody System, Stable-C Interbody SystemNexus Spine, LLC20235—
+5K232315Catalyst Bone Void FillerOssdsign AB20237—
+5K231199Solar Lumbar Interbody Fusion SystemDegen Medical20235—
+5K223335SIRION Lateral Lumbar Interbody SystemAstura Medical20230—
+5K223418DeGen Impulse AM™ SystemDegen Medical20236—
+5K223688CONDUIT™ Lateral Lumbar Intervertebral Fusion Cage, CONDUIT™ InstrumentsMedos International Sàrl20230—
+5K223413Pisces™-SA STANDALONE ALIF Interbody SystemOsseus Fusion Systems20233—
+5K222554EL CAPITAN Anterior Lumbar Interbody FusionAstura Medical20235—
+5K223731NuVasive Modulus-C Interbody SystemNuvasive, Inc.202311—
+5K221926Invictus® Bone Cement, Invictus Spinal Fixation SystemAlphatec Spine, Inc.202214—
+5K221806TruLift Lateral Expandable Spacer System & Lateral Plate SystemLife Spine, Inc.20221—
+5K222270HEDRON Cervical Spacers, HEDRON Lumbar Spacers, SABLE Expandable Spacer, ExcelsiusGPS…Globus Medical, Inc.202223—
+5K222276CONDUIT Cages; FIBERGRAFT BG PuttyDepuy Spine202229—
+5K213417Ghost Spacer SystemLife Spine, Inc.20220—
+5K221403Cortera Spinal Fixation SystemSurgalign Spine Technologies202232
+5K221535Align Lumbar Interbody Fusion SystemAcuity Surgical Devices, LLC20223—
+5K214010Anteralign Spinal System with Titan nanoLOCK Surface TechnologyMedtronic Sofamor Danek USA202249—
+5K212358Romero Cervical CageSpineup, Inc.20226—
+5K212904SeaSpine WaveForm C Interbody SystemSeaSpine Orthopedics Corporation202115—
+5K213359SeaSpine WaveForm, C Interbody SystemSeaSpine Orthopedics Corporation20217—
+5K212524Anteralign Spinal System with Titan nanoLOCK Surface TechnologyMedtronic Sofamor Danek USA, Inc.202155—
+5K212967AxTiHA Stand-Alone ALIF SystemInnovasis, Inc.20211—
+5K203125Invictus™ OCT Spinal Fixation SystemAlphatec Spine, Inc.20200—
+5K203056Invictus™ Spinal Fixation SystemAlphatec Spine, Inc.202061—
+5K202327Invictus™ OsseoScrew® SystemAlphatec Spine, Inc.20200—
+5K200936Invictus™ CT Spinal Fixation SystemAlphatec Spine, Inc.20203—
+6K262230Mg OSTEOREVIVE™;Mg OSTEOCRETE™Bone Solutions, Inc.20260—
+6K261451ZSAlign Cervical Interbody SystemZSFab, Inc.20260—
+6K261809Interwedge® Standalone LateralFoundation Surgical Group20260—
+6K262094E3D™-C Interbody SystemEvolution Spine20260—
+6K261284Invictus® Small Stature Spinal Fixation System; Invictus® 2.0 Spinal Fixation SystemAlphatec Spine, Inc.20260—
+6K254130C.A. Medical Interbody Fusion SystemC.A. Medical, LLC20260—
+6K253420Admiral ACP System; Explorer TO System; Laminoplasty System; Manta Ray TDF Spacer…SeaSpine Orthopedics Corporation20260—
+6K260036NeckTune™ 3D SA Cervical CageMedyssey Co, Ltd.20260—
+6K260810Anteralign LS coverplateTyber Medical, LLC20260—
+6K260385aprevo® anterior and lateral lumbar interbody system; aprevo® posterior and…Carlsmed, Inc.20260—
+6K252240Spectrum Spine Cervical Cage System; Spectrum Spine Lumbar Cage SystemSpectrum Spine20260—
+6K253615Invictus Bands SystemAlphatec Spine, Inc.20260—
+6K252597Valence Robotic Navigation System; Valence Robotic Navigation Instruments (For Use with…Alphatec Spine, Inc.20261—
+6K254105Hive™ Standalone Cervical System and Hive™ C Interbody SystemNanoHive Medical, LLC20260—
+6K252205Curiteva Porous PEEK Cervical Interbody System; Curiteva Porous PEEK Lumbar Interbody…Curiteva, Inc.20260—
+6K252894aprevo® cervical interbody systemCarlsmed, Inc.20261—
+6K253876HEDRON™ Cervical Spacers (HEDRON C-MIS™ Spacer)Globus Medical, Inc.20251—
+6K251302OptiMesh Multiplanar Expandable Interbody Fusion SystemSpineology, Inc.20250—
+6K253377Expandable Titanium PLIF/TLIF SystemSpectrum Spine, Inc.20250—
+6K253147FIBERGRAFT™ BG Putty GPS Bone Graft Substitute FIBERGRAFT™ BG Putty Bone Graft…Prosidyan, Inc.20250—
+6K252737DeGen Medical Latitude-C AM Cervical Interbody Fusion SystemDegen Medical20250—
+6K251965Proximity Anterior Cervical Plate System; Segmental Plating System (SPS)Alphatec Spine, Inc.20250—
+6K251335Tera Lumbar Interbody Fusion System (Various PNs)Acuity Surgical Devices, LLC20251—
+6K243474MagnetOs MISKuros Biosciences B.V20250—
+6K243934Stable-L Lumbar Interbody SystemNexus Spine, LLC20250—
+6K250603AxTiHA® Stand-Alone ALIF SystemInnovasis20250—
+6K242797OsteoFlo HydroFiberSurGenTec, LLC20241—
+6K241077DeGen Medical Patient Specific Implant (PSI) SystemDegen Medical20242—
+6K241892Cortera™ Spinal Fixation SystemXtant Medical Holdings, Inc.20242—
+6K241564Actifuse ABX; Actifuse MIS; Actifuse Shape; ALTAPORE; ALTAPORE SHAPE; ALTAPORE MISBaxter Healthcare Corporation20240—
+6K241413sagAlign Lumbar Cage System (Various PNs)Acuity Surgical Devices, LLC20240—
+6K241467Stable-C Interbody SystemNexus Spine, LLC20242—
+6K240893ARTFX MEDICAL Cervical PEEK CagesArtfx Medical20244—
+6K241212MagnetOs Easypack PuttyKuros Biosciences20241—
+6K241466Shoreline ACS Interbody System; Shoreline RT Interbody System; Regatta Lateral System…SeaSpine Orthopedics Corporation20243—
+6K232256Alcantara Thoracolumbar Plate SystemCamber Spine Technologies, LLC20240—
+6K233375Tranquil-L Interbody SystemNexus Spine, LLC20240—