510(k) Report

Devices descending from K102738

328 later devices reach Lanx Fusion System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+8K250486Skyway Anterior Cervical Plate SystemKyocera Medical Technologies Inc. (KMTI)20251—
+8K241783FortiVy™ OsteoVy™ Lumbar IBFVy Spine, LLC20250—
+8K241892Cortera™ Spinal Fixation SystemXtant Medical Holdings, Inc.20242—
+8K240893ARTFX MEDICAL Cervical PEEK CagesArtfx Medical20244—
+8K233640Segmental Plating System (SPS);IdentiTi SPS Interbody System;IdentiTi NanoTec SPS…Alphatec Spine, Inc.20245—
+8K232044Invictus Robotic Navigation InstrumentsAlphatec Spine, Inc.20233—
+8K232275Invictus® Spinal Fixation SystemAlphatec Spine, Inc.202311—
+8K230721ATEC Lateral Plate SystemAlphatec Spine, Inc.20230—
+8K230026SqualeImplanet, S.A.20230—
+8K203714NuVasive Thoracolumbar Interbody Systems: NuVasive CoRoent Thoracolumbar System…Nu Vasive, Incorporated202166—
+8K213460Invictus Spinal Fixation SystemAlphatec Spine, Inc.202117—
+8K203038Toro-L Interbody Fusion SystemIntegrity Implants, Inc.20215—
+8K203201NuVasive Thoracolumbar Interbody Systems: CoRoent Thoracolumbar System, CoRoent XL…Nu Vasive, Incorporated202194—
+8K192760NuVasive Modulus XLIF Interbody SystemNu Vasive, Incorporated2019163—
+8K180777K2M Expandable Interbody SystemK2m, Inc.20180—
+8K173892NuVasive® XLX Interbody SystemNu Vasive, Incorporated2018115—
+9K261451ZSAlign Cervical Interbody SystemZSFab, Inc.20260—
+9K253216IntraOp Alignment System; CONTOUR3D Bending SystemAlphatec Spine, Inc.20260—
+9K252686EffortMed PEEK Cages & Corpectomy CagesEffortmed, LLC20251—
+9K251965Proximity Anterior Cervical Plate System; Segmental Plating System (SPS)Alphatec Spine, Inc.20250—
+9K250669Adaptix™ Interbody System with Titan nanoLOCK™ Surface TechnologyMedtronic Sofamor Danek USA, Inc.20250—
+9K250521NanoBone® SBX Putty ; NanoBone® QDBiocomposites, Ltd.20250—
+9K250556Porous Biologic ScaffoldVentris Medical20250—
+9K243706Mastergraft Matrix EXT; Mastergraft Strip; Mastergraft Putty; Mastergraft GranulesMedtronic Sofamor Danek, Inc.20250—
+9K243946EffortMed Spinal Fixation SystemEffortmed, LLC20251—
+9K241167BioSphere Putty; BioSphere MIS PuttySynergy Biomedical20240—
+9K242299NovaBone Putty - Synthetic Bioactive Bone GraftNovabone Products, LLC20241—
+9K242273Cove Putty, OsteoCove PuttySeaSpine Orthopedics Corporation202402
+9K234035COSINE™ SpacerGlobus Medical, Inc.20240—
+9K240951Invictus Robotic Navigation InstrumentsAlphatec Spine20242—
+9K240566Reef L Interbody System; WaveForm L Interbody SystemSeaSpine Orthopedics Corporation20245—
+9K240442MagnetOs PuttyKuros Biosciences B.V20243—
+9K240507NuVasive AttraX ScaffoldNuvasive, Inc.20240—
+9K240458Synthetic Bone PuttyVentris Medical20242—
+9K240459Cerament Bone Void FillerBonesupport AB20240—
+9K232347MagnetOs GranulesKuros Biosciences B.V20242—
+9K233607MagnetOs Easypack PuttyKuros Biosciences B.V20232—
+9K233490SIGNAFUSE Bioactive Strip (SBS); SIGNAFUSE PuttyBioventus, LLC20232—
+9K233245MagnetOs Flex MatrixKuros Biosciences B.V20230—
+9K230927OptiMesh Multiplanar Expandable Interbody Fusion SystemSpineology, Inc.20231—
+9K232315Catalyst Bone Void FillerOssdsign AB20237—
+9K221894Lumbar Expandable lnterbody Spacers -Additional Indications/ImplantsGlobus Medical, Inc.20232—
+9K230894NuVasive Modulus ALIF SystemNu Vasive, Incorporated20234—
+9K223688CONDUIT™ Lateral Lumbar Intervertebral Fusion Cage, CONDUIT™ InstrumentsMedos International Sàrl20230—
+9K223731NuVasive Modulus-C Interbody SystemNuvasive, Inc.202311—
+9K221751NuVasive Cohere ALIF System Intervertebral Body Fusion DeviceNu Vasive, Incorporated20223—
+9K222276CONDUIT Cages; FIBERGRAFT BG PuttyDepuy Spine202229—
+9K221325CONDUIT Lateral Switch PlateMedos International SARL20221—
+9K220478NuVasive MOD-EX XLIF Interbody System, NuVasive MOD-EX XLIF Plated 2.0 Interbody SystemNu Vasive, Incorporated20222—
+9K213355Toro-L Interbody Fusion SystemIntegrity Implants, Inc.20224—
+9K212498Stable-L Standalone Lumbar Interbody SystemNexus Spine, LLC20227—
+9K211258Endoskeleton TC Interbody System, Endoskeleton TCS Interbody System, Endoskeleton TA…Medtronic Sofamor Danek USA, Inc.202175—
+9K210439NuVasive MOD-EX XLIF Interbody SystemNu Vasive, Incorporated20214—
+9K210271NuVasive Modulus ALIF SystemNu Vasive, Incorporated20215—
+9K201692NuVasive Modulus XLIF Interbody SystemNu Vasive, Incorporated202067—
+9K201820NuVasive Thoracolumbar Interbody Systems: CoRoent Thoracolumbar System, CoRoent XL…Nu Vasive, Incorporated2020156—
+9K193593NuVasive 3DP Interfixated ALIF SystemNu Vasive, Incorporated2020157—
+9K193506NuVasive X-Core Expandable VBR System, NuVasive X-Core Mini Cervical Expandable VBR SystemNu Vasive, Incorporated20201—
+10K262230Mg OSTEOREVIVE™;Mg OSTEOCRETE™Bone Solutions, Inc.20260—
+10K260850Osteomni Spinal Cages SystemOsteomni, Inc.20260—
+10K253260ORIO-3D Cage SystemSpineCraft20260—
+10K254247Osteomni Spinal Fixation SystemOsteomni, Inc.20260—
+10K251302OptiMesh Multiplanar Expandable Interbody Fusion SystemSpineology, Inc.20250—
+10K253147FIBERGRAFT™ BG Putty GPS Bone Graft Substitute FIBERGRAFT™ BG Putty Bone Graft…Prosidyan, Inc.20250—
+10K251444Endoskeleton™ Interbody SystemsMedtronic Sofamor Danek USA, Inc.20250—
+10K243474MagnetOs MISKuros Biosciences B.V20250—
+10K243074Spectrum Spine Lumbar Cage SystemSpectrum Spine, Inc.20252—
+10K242797OsteoFlo HydroFiberSurGenTec, LLC20241—
+10K232996Iatrical Interbody Lumbar Fusion Systems (Model ALIF, Model TLIF, Model LLIF)Shanghai Iatrical-Ti Technologies CO, Ltd.20240—
+10K241564Actifuse ABX; Actifuse MIS; Actifuse Shape; ALTAPORE; ALTAPORE SHAPE; ALTAPORE MISBaxter Healthcare Corporation20240—
+10K241212MagnetOs Easypack PuttyKuros Biosciences20241—
+10K240838Spectrum Spine Cervical Cage SystemSpectrum Spine, Inc.20244—
+10K240424Mineral Collagen Composite Bioactive Moldable Bone Graft MatrixCollagen Matrix, Inc.20240—
+10K240453ReBOSSISOrthorebirth Co., Ltd.202402
+10K234013Mg OSTEOINJECT™; Mg OSTEOREVIVE™; Mg OSTEOCRETE™Bone Solutions, Inc.20243—
+10K231486Stable-L Standalone Lumbar Interbody SystemNexus Spine, LLC20231—
+10K232173Ascend VBR System, Ascend NanoTec VBR SystemAlphatec Spine, Inc.20230—
+10K231076VariLift®-C Interbody Fusion SystemWenzel Spine, Inc.20234—
+10K232530Stable-L Standalone Lumbar Interbody System, Stable-C Interbody SystemNexus Spine, LLC20235—
+10K231735NuVasive CoRoent Small Interbody System; NuVasive CoRoent Small Contoured Interbody…Nu Vasive, Incorporated20239—
+10K214010Anteralign Spinal System with Titan nanoLOCK Surface TechnologyMedtronic Sofamor Danek USA202249—
+10K212904SeaSpine WaveForm C Interbody SystemSeaSpine Orthopedics Corporation202115—
+10K213359SeaSpine WaveForm, C Interbody SystemSeaSpine Orthopedics Corporation20217—
+10K212524Anteralign Spinal System with Titan nanoLOCK Surface TechnologyMedtronic Sofamor Danek USA, Inc.202155—
+10K210214NuVasive Modulus Expandable Posterior Lumbar MOD-EX PL Interbody SystemNu Vasive, Incorporated20213—
+10K203278INDEPENDENCE Spacers, HEDRON IA, MAGNIFY-S Spacers, MONUMENT Spacers, InterContinental…Globus Medical, Inc.202135—
+11K262595VariLift-C Cervical Interbody Fusion SystemWenzel Spine, Inc.20260—
+11K261408SABER-XA SystemElevation Spine20260—
+11K260810Anteralign LS coverplateTyber Medical, LLC20260—
+11K253876HEDRON™ Cervical Spacers (HEDRON C-MIS™ Spacer)Globus Medical, Inc.20251—
+11K253377Expandable Titanium PLIF/TLIF SystemSpectrum Spine, Inc.20250—
+11K251522Mg OSTEOINJECT™; Mg OSTEOREVIVE™; Mg OSTEOCRETE™Bone Solutions, Inc.20251—
+11K243949OsteoFlo HydroFiberSurGenTec, LLC20250—
+11K243934Stable-L Lumbar Interbody SystemNexus Spine, LLC20250—
+11K242372Mg OSTEOREVIVE™, Mg OSTEOCRETE™Bone Solutions, Inc.20242—
+11K241467Stable-C Interbody SystemNexus Spine, LLC20242—
+11K233375Tranquil-L Interbody SystemNexus Spine, LLC20240—
+11K240416Tranquil-C Interbody SystemNexus Spine, LLC20243—
+11K233735ADIRA™ Lateral Plate SystemGlobus Medical, Inc.20240—
+11K233414Shoreline ACS Interbody System; Shoreline RT Interbody SystemSeaSpine Orthopedics Corporation20238—