510(k) Report

Devices descending from K052384

455 later devices reach Lanx VBR System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+8K223731NuVasive Modulus-C Interbody SystemNuvasive, Inc.202311—
+8K223671CONDUIT LLIF Straight InsertersEnztec Limited20231—
+8K223105Tesera-K SC SystemKyocera Medical Technologies, Inc.20225—
+8K221926Invictus® Bone Cement, Invictus Spinal Fixation SystemAlphatec Spine, Inc.202214—
+8K223190Hive™ Standalone Cervical SystemNanoHive Medical, LLC20225—
+8K222455Calibrate LTX Interbody SystemAlphatec Spine, Inc.20228—
+8K222973IdentiTi and Transcend Interbody Systems: IndentiTi Cervical Porous Ti Interbody System…Alphatec Spine, Inc.202213—
+8K220711SeaSpine Meridian System, SeaSpine Meridian Anterior Plate SystemSeaSpine Orthopedics Corporation202210—
+8K214010Anteralign Spinal System with Titan nanoLOCK Surface TechnologyMedtronic Sofamor Danek USA202249—
+8K212358Romero Cervical CageSpineup, Inc.20226—
+8K212904SeaSpine WaveForm C Interbody SystemSeaSpine Orthopedics Corporation202115—
+8K213359SeaSpine WaveForm, C Interbody SystemSeaSpine Orthopedics Corporation20217—
+8K212524Anteralign Spinal System with Titan nanoLOCK Surface TechnologyMedtronic Sofamor Danek USA, Inc.202155—
+8K211805IdentiTi Porous Ti Interbody System, Transcend PEEK Interbody System, IdentiTi NanoTec…Alphatec Spine, Inc.202138—
+8K210090Impulse AM Interbody Fusion SystemDegen Medical20217—
+8K211873PSX Interbody SystemAlphatec Spine, Inc.202111—
+8K210583SeaSpine WaveForm™ A Interbody SystemSeaSpine Orthopedics Corporation202114—
+8K201287Impulse Interbody Fusion SystemDegen Medical20208—
+8K202587ATEC Lateral Interbody SystemAlphatec Spine, Inc.202039—
+8K200953NuVasive® Cohere® Thoracolumbar Interbody SystemNu Vasive, Incorporated2020141—
+8K201500Life Spine Plateau-A Ti Anterior Lumbar Spacer & Plateau-X Ti Lateral Lumbar SpacerLife Spine, Inc.20203—
+8K192938Invictus™ Spinal Fixation SystemAlphatec Spine, Inc.201969—
+8K191091Rampart One Lumbar Interbody Fusion SystemSpineology, Inc.20191—
+8K182322Duo Lumbar Interbody Fusion DeviceSpineology, Inc.20182—
+8K173025NuVasive® MLX® – Medial Lateral Expandable Lumbar Interbody System; NuVasive® AP…Nu Vasive, Incorporated20188—
+8K172123NuVasive® Modulus XLIF Interbody SystemNu Vasive, Incorporated2017227—
+9K262595VariLift-C Cervical Interbody Fusion SystemWenzel Spine, Inc.20260—
+9K261451ZSAlign Cervical Interbody SystemZSFab, Inc.20260—
+9K260810Anteralign LS coverplateTyber Medical, LLC20260—
+9K253401SCRIPT™ Implant SystemGlobus Medical, Inc.20260—
+9K250599ExcelsiusGPS™ InstrumentsGlobus Medical, Inc.20250—
+9K253377Expandable Titanium PLIF/TLIF SystemSpectrum Spine, Inc.20250—
+9K252113PRADO™ Lumbar Interbody Fusion SystemBethesda Medical Devices20250—
+9K243474MagnetOs MISKuros Biosciences B.V20250—
+9K242928Tesera-k SC SystemKyocera Medical Technologies, Inc.20250—
+9K250486Skyway Anterior Cervical Plate SystemKyocera Medical Technologies Inc. (KMTI)20251—
+9K250667DeGen Medical Patient Specific Implant (PSI) SystemDegen Medical20251—
+9K241783FortiVy™ OsteoVy™ Lumbar IBFVy Spine, LLC20250—
+9K243802aprevo® anterior and lateral lumbar interbody fusion device, aprevo® anterior lumbar…Carlsmed, Inc.20253—
+9K243461Calibrate Interbody SystemsAlphatec Spine, Inc.20250—
+9K242483Genesys Spine AIS-C II Cervical Interbody Fusion SystemGenesys Spine20250—
+9K242797OsteoFlo HydroFiberSurGenTec, LLC20241—
+9K240893ARTFX MEDICAL Cervical PEEK CagesArtfx Medical20244—
+9K241212MagnetOs Easypack PuttyKuros Biosciences20241—
+9K241519Invictus® Small Stature Spinal Fixation SystemAlphatec Spine, Inc.20242—
+9K233640Segmental Plating System (SPS);IdentiTi SPS Interbody System;IdentiTi NanoTec SPS…Alphatec Spine, Inc.20245—
+9K232044Invictus Robotic Navigation InstrumentsAlphatec Spine, Inc.20233—
+9K232275Invictus® Spinal Fixation SystemAlphatec Spine, Inc.202311—
+9K232014CONDUIT™ ATP InsertersEnztec Limited20230—
+9K231735NuVasive CoRoent Small Interbody System; NuVasive CoRoent Small Contoured Interbody…Nu Vasive, Incorporated20239—
+9K230721ATEC Lateral Plate SystemAlphatec Spine, Inc.20230—
+9K230026SqualeImplanet, S.A.20230—
+9K223418DeGen Impulse AM™ SystemDegen Medical20236—
+9K220296Manta Ray TDF SpacerSeaSpine Orthopedics Corporation20231—
+9K223494CD Horizon Spinal SystemMedtronic202317—
+9K223153Catalyft LS Expandable Interbody System with Titan nanoLOCK Surface TechnologyMedtronic Sofamor Danek USA, Inc.20220—
+9K222732WaveForm A Interbody SystemSeaSpine Orthopedics Corporation20229—
+9K213417Ghost Spacer SystemLife Spine, Inc.20220—
+9K221403Cortera Spinal Fixation SystemSurgalign Spine Technologies202232
+9K220523restor3d TiDAL Lumbar Interbody Fusion DeviceRestor3D20222—
+9K221180Anteralign (TM) Spinal System with Titan NanoLOCK Surface Technology Navigated InstrumentsMedtronic Sofamor Danek USA, Inc.20222—
+9K214011Catalyft™ PL Expandable Interbody System Navigated Instruments, Anteralign™ TL Spinal…Medtronic Sofamor Danek USA, Inc.20221—
+9K203714NuVasive Thoracolumbar Interbody Systems: NuVasive CoRoent Thoracolumbar System…Nu Vasive, Incorporated202166—
+9K203038Toro-L Interbody Fusion SystemIntegrity Implants, Inc.20215—
+9K203201NuVasive Thoracolumbar Interbody Systems: CoRoent Thoracolumbar System, CoRoent XL…Nu Vasive, Incorporated202194—
+9K203125Invictus™ OCT Spinal Fixation SystemAlphatec Spine, Inc.20200—
+9K203056Invictus™ Spinal Fixation SystemAlphatec Spine, Inc.202061—
+9K202327Invictus™ OsseoScrew® SystemAlphatec Spine, Inc.20200—
+9K200936Invictus™ CT Spinal Fixation SystemAlphatec Spine, Inc.20203—
+9K192760NuVasive Modulus XLIF Interbody SystemNu Vasive, Incorporated2019163—
+9K192047Rampart™ One Lumbar Interbody Fusion SystemSpineology, Inc.20190—
+9K180777K2M Expandable Interbody SystemK2m, Inc.20180—
+9K173892NuVasive® XLX Interbody SystemNu Vasive, Incorporated2018115—
+10K261284Invictus® Small Stature Spinal Fixation System; Invictus® 2.0 Spinal Fixation SystemAlphatec Spine, Inc.20260—
+10K253216IntraOp Alignment System; CONTOUR3D Bending SystemAlphatec Spine, Inc.20260—
+10K260989Varion Thoracolumbar Fixation SystemKyocera Medical Technologies Inc. (KMTI)20260—
+10K252542LEO Spinal SystemZheJiang Decans Medical Devices Co., Ltd.20260—
+10K260216CD Horizon™ ModuLeX™ Fenestrated Screw Set; CD Horizon™ ModuLeX™ Spinal SystemMedtronic Sofamor Danek USA, Inc.20260—
+10K260011Foundation Surgical Navigated Lateral Disc Prep InstrumentsFoundation Surgical Group, Inc.20260—
+10K253615Invictus Bands SystemAlphatec Spine, Inc.20260—
+10K252597Valence Robotic Navigation System; Valence Robotic Navigation Instruments (For Use with…Alphatec Spine, Inc.20261—
+10K253876HEDRON™ Cervical Spacers (HEDRON C-MIS™ Spacer)Globus Medical, Inc.20251—
+10K251829DeGen Medical Patient Specific Implant (PSI) SystemDegen Medical20250—
+10K252686EffortMed PEEK Cages & Corpectomy CagesEffortmed, LLC20251—
+10K252742Navigated InstrumentsTyber Medical, LLC20251—
+10K253335CD Horizon™ Spinal SystemMedtronic Sofamor Danek USA, Inc.20250—
+10K253331PressON Spinal Fixation SystemNexus Spine20250—
+10K251965Proximity Anterior Cervical Plate System; Segmental Plating System (SPS)Alphatec Spine, Inc.20250—
+10K243949OsteoFlo HydroFiberSurGenTec, LLC20250—
+10K242273Cove Putty, OsteoCove PuttySeaSpine Orthopedics Corporation202402
+10K234035COSINE™ SpacerGlobus Medical, Inc.20240—
+10K241892Cortera™ Spinal Fixation SystemXtant Medical Holdings, Inc.20242—
+10K241082INNOVERSE Navigation InstrumentsInnosys Co., Ltd.20240—
+10K240951Invictus Robotic Navigation InstrumentsAlphatec Spine20242—
+10K240566Reef L Interbody System; WaveForm L Interbody SystemSeaSpine Orthopedics Corporation20245—
+10K240442MagnetOs PuttyKuros Biosciences B.V20243—
+10K233951CD Horizon ModuLeX Spinal System (Shanks, Head Assemblies, and Set Screw)Medtronic Sofamor Danek USA, Inc.20245—
+10K240507NuVasive AttraX ScaffoldNuvasive, Inc.20240—
+10K233508iFuse Bedrock Granite® Implant SystemSI-BONE, Inc.20245—
+10K234087restor3d TIDAL Lumbar Interbody Fusion SystemRestor3D20240—