510(k) Report

Devices descending from K083815

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

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+9K232315Catalyst Bone Void FillerOssdsign AB20237—
+9K221894Lumbar Expandable lnterbody Spacers -Additional Indications/ImplantsGlobus Medical, Inc.20232—
+9K230894NuVasive Modulus ALIF SystemNu Vasive, Incorporated20234—
+9K223326Axiom PSR SystemRestor3D202301
+9K221751NuVasive Cohere ALIF System Intervertebral Body Fusion DeviceNu Vasive, Incorporated20223—
+9K222383Anteralign™ LS Spinal System with Titan nanoLOCK™ Surface Technology MAZORX Stealth (TM)…Medtronic Sofamor Danek USA, Inc.20220—
+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—
+9K213460Invictus Spinal Fixation SystemAlphatec Spine, Inc.202117—
+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—
+10K261060Navigated LLIF Impactable TrackerTyber Medical, LLC20260—
+10K260850Osteomni Spinal Cages SystemOsteomni, Inc.20260—
+10K253260ORIO-3D Cage SystemSpineCraft20260—
+10K254274ARx® SAI Implant SystemLife Spine, Inc.20260—
+10K251302OptiMesh Multiplanar Expandable Interbody Fusion SystemSpineology, Inc.20250—
+10K252322SIros-X SystemGenesys Spine20250—
+10K253094iFuse Bedrock Granite Implant SystemSI-BONE, Inc.20250—
+10K243946EffortMed Spinal Fixation SystemEffortmed, LLC20251—
+10K243007CD Horizon™ Spinal SystemMedtronic Sofamor Danek USA, Inc.20243—
+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—
+10K241464ARx® SAI Implant SystemLife Spine, Inc.20241—
+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—
+10K232530Stable-L Standalone Lumbar Interbody System, Stable-C Interbody SystemNexus Spine, LLC20235—
+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—
+11K261408SABER-XA SystemElevation Spine20260—
+11K253802KHEIRON® Spinal Fixation System, including patient specific K-RODS.M.A.I.O20261—
+11K254247Osteomni Spinal Fixation SystemOsteomni, Inc.20260—
+11K251522Mg OSTEOINJECT™; Mg OSTEOREVIVE™; Mg OSTEOCRETE™Bone Solutions, Inc.20251—
+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—
+11K222270HEDRON Cervical Spacers, HEDRON Lumbar Spacers, SABLE Expandable Spacer, ExcelsiusGPS…Globus Medical, Inc.202223—
+12K262828KHEIRON® Spinal Fixation System, including patient specific K-RODS.M.A.I.O20260—
+12K261279DeltaNEC Interbody SystemNexus Spine20260—
+12K223837SPIRA®-C Integrated Fixation SystemCamber Spine Technologies20230—