510(k) Report

Devices descending from K043479

1,214 later devices reach MC+ Partial VBR through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+6K191039Navigated T2 STRATOSPHERE Inserters and Navigated TemplatesMedtronic Sofamor Danek USA, Inc.201918—
+6K191423Normandy VBR SystemZavation Medical Products, LLC20193—
+6K183064TxTi IBF SystemInnovasis, Inc.2019481
+6K190684LxHA PEEK Lateral IBF SystemInnovasis, Inc.20190—
+6K191263Idys ALIF TiVacClariance, Sas20190—
+6K190877Juliet® Ti LL Lumbar Interbody DeviceSpineart201911
+6K183184FlareHawk Interbody Fusion SystemIntegrity Implants, Inc.201912—
+6K183426MectaLIF Anterior Stand Alone ExtensionMedacta International S.A.20191—
+6K190067Velofix Interbody Fusion SystemU&I Corporation20193—
+6K183510T2 STRATOSPHERE Expandable Corpectomy SystemMedtronic Sofamor Danek USA, Inc.201927—
+6K181118Reliance Lumbar IBF SystemReliance Medical Systems20190—
+6K181589Curiteva Lumbar Interbody Fusion SystemCuriteva, LLC20186—
+6K182007Renovis Tesera C/Tesera SC Anterior Cervical Fusion (ACF) SystemRenovis Surgical Technologies20180—
+6K181603EVEREST Spinal System, RANGE (MESA and DENALI) Spinal System, CASPIAN OCT (MESA Mini and…K2m, Inc.20185—
+6K181386NuVasive Brigade Lateral SystemNu Vasive, Incorporated2018158—
+6K181453ATEC ALIF Spacer SystemAlphatec Spine, Inc.2018111—
+6K181079SeaSpine Regatta Lateral SystemSeaSpine Orthopedics Corporation201863—
+6K180695FBC 921 (Alif)Fbc Device Aps20180—
+6K181068CREO® Stabilization System, REVERE® Stabilization SystemGlobus Medical, Inc.20182—
+6K181188EVEREST Spinal SystemK2m, Inc.20186—
+6K180002Rampart One Lumbar Interbody Fusion DeviceSpineology, Inc.20182—
+6K173606SeaSpine Vu a•POD Prime NanoMetalene Intervertebral Body Fusion Device, SeaSpine Vu…SeaSpine Orthopedics Corporation201859—
+6K171434ROCCIA® MultiLIFSilony Medical GmbH20174—
+6K173260SeaSpine Spacer System (NanoMetalene)- Hollywood, Hollywood VI, Ventura, Pacifica…SeaSpine Orthopedics Corporation201767—
+6K170235Lucent®Spinal Elements, Inc.2017107—
+6K172253Altus Spine Cervical Interbody Fusion SystemAltus Partners, LLC20170—
+6K172392Lateral Spinal Truss System (LSTS) Interbody Fusion Device4Web, Inc.20171—
+6K172343Fortilink® Interbody Fusion (IBF) System with TETRAfuse® 3D TechnologyRti Surgical, Inc.201710—
+6K170119Calix Lumbar Spinal Implant SystemX-Spine Systems, Inc.201711
+6K171321K2M Navigation InstrumentsK2m201711
+6K171630LumFuse-TPPrecifit Medical, Ltd.20171—
+6K170962NuVasive® CoRoent® Thoracolumbar SystemNu Vasive, Incorporated2017304—
+6K163707NuVasive CoRoent Ti-C SystemNu Vasive, Incorporated201719—
+6K170592NuVasive BASE Interfixated Titanium SystemNu Vasive, Incorporated2017186—
+6K170455MectaLIF Anterior Stand AloneMedacta International S.A.20174—
+6K163409Rampart (TM) T Lumbar Interbody Fusion DeviceSpineology, Inc.20170—
+6K162879Elite Expandable Interbody Fusion DeviceSpineology, Inc.20179—
+6K162358T-PAL Spacer System, T-PAL Titanium Spacer System, SYNFIX Evolution SystemSynthes USA Products, LLC2016127—
+6K161173Avenue® T TLIF CageLdr Spine USA, Inc.20163—
+6K153105MLX™ - Medial Lateral Expandable Lumbar Interbody SystemNu Vasive, Incorporated2016234—
+6K160051NuVasive® Interfixated Interbody SystemNu Vasive, Incorporated2016396—
+6K153495Avenue L Lateral Lumbar Cage, Avenue T TLIF Cage System, ROI-A ALIF Cage System, ROI-T…Ldr Spine USA20161891
+6K153525Seneka II Polyscrew Pedicle Fixation SystemSenecka Spine20160—
+6K151726AVS AL and AVS ALign PEEK Spacers, AVS PL and AVS UniLIF PEEK Spacers, AVS TL PEEK…Stryker Corporation20161391
+6K152651AccuLIF TL and PL CageStryker Corporation201530—
+6K152304Tritanium PL CageStryker20154481
+6K141135Juliet LLSpineart2014146—
+6K142066Aero-LL Lumbar Cage SystemStryker Corporation20142—
+7K262025Innovasis AxTiHA® Stand-Alone ALIF System;Innovasis TxTiHA® IBF System;Innovasis…INNO Holdings Inc. DBA Innovasis20260—
+7K261113Op.n™ Spine Navigation and Robotic GuidanceEcential Robotics20261—
+7K261284Invictus® Small Stature Spinal Fixation System; Invictus® 2.0 Spinal Fixation SystemAlphatec Spine, Inc.20260—
+7K253151Fule Interbody Fusion Cage SystemBeijing Fule Science & Technology Development Co., Ltd.20260—
+7K260989Varion Thoracolumbar Fixation SystemKyocera Medical Technologies Inc. (KMTI)20260—
+7K260850Osteomni Spinal Cages SystemOsteomni, Inc.20260—
+7K253739SCRIPT™ Rods, CREO™ Stabilization System, REVERE® Stabilization System, REVERE® 4.5…Globus Medical, Inc.20260—
+7K252542LEO Spinal SystemZheJiang Decans Medical Devices Co., Ltd.20260—
+7K260216CD Horizon™ ModuLeX™ Fenestrated Screw Set; CD Horizon™ ModuLeX™ Spinal SystemMedtronic Sofamor Danek USA, Inc.20260—
+7K260011Foundation Surgical Navigated Lateral Disc Prep InstrumentsFoundation Surgical Group, Inc.20260—
+7K253615Invictus Bands SystemAlphatec Spine, Inc.20260—
+7K252597Valence Robotic Navigation System; Valence Robotic Navigation Instruments (For Use with…Alphatec Spine, Inc.20261—
+7K252742Navigated InstrumentsTyber Medical, LLC20251—
+7K253335CD Horizon™ Spinal SystemMedtronic Sofamor Danek USA, Inc.20250—
+7K253147FIBERGRAFT™ BG Putty GPS Bone Graft Substitute FIBERGRAFT™ BG Putty Bone Graft…Prosidyan, Inc.20250—
+7K253331PressON Spinal Fixation SystemNexus Spine20250—
+7K251003X-PAC® LLIF Expandable Lateral Cage SystemExpanding Innovations, Inc.20250—
+7K250602X-PAC® N-GAGE™ Lumbar Plate SystemExpanding Innovations, Inc.20250—
+7K243386Ventris Intervertebral Body Fusion DeviceAcuity Surgical Devices, LLC20252—
+7K250486Skyway Anterior Cervical Plate SystemKyocera Medical Technologies Inc. (KMTI)20251—
+7K250521NanoBone® SBX Putty ; NanoBone® QDBiocomposites, Ltd.20250—
+7K250667DeGen Medical Patient Specific Implant (PSI) SystemDegen Medical20251—
+7K250556Porous Biologic ScaffoldVentris Medical20250—
+7K243706Mastergraft Matrix EXT; Mastergraft Strip; Mastergraft Putty; Mastergraft GranulesMedtronic Sofamor Danek, Inc.20250—
+7K241167BioSphere Putty; BioSphere MIS PuttySynergy Biomedical20240—
+7K243671ExcelsiusGPS® InstrumentsGlobus Medical, Inc.20240—
+7K242350Spinal Alignment Solutions Pelvic Incidence (PI) Rod SystemSpinal Alignment Solutions, Inc.20241—
+7K242829BluEX Lumbar Expandable Cage SystemL&K BIOMED Co., Ltd.20240—
+7K242299NovaBone Putty - Synthetic Bioactive Bone GraftNovabone Products, LLC20241—
+7K242273Cove Putty, OsteoCove PuttySeaSpine Orthopedics Corporation202402
+7K241892Cortera™ Spinal Fixation SystemXtant Medical Holdings, Inc.20242—
+7K233793CarboClear® X Pedicle Screw SystemCarboFix Orthopedics, Ltd.20241—
+7K241863Erisma® Lp Spinal Fixation System; Erisma® LP MISClariance20240—
+7K241019aprevo® TLIF-C Articulating SystemCarlsmed20244—
+7K240721ExcelsiusFlex™Globus Medical, Inc.20240—
+7K241082INNOVERSE Navigation InstrumentsInnosys Co., Ltd.20240—
+7K240749PILLAR SA Ti Spacer System (82-XXX)Orthofix, Inc.202402
+7K232790KONG®-TL VBR System and KONG® C VBR SystemIcotec AG20240—
+7K240442MagnetOs PuttyKuros Biosciences B.V20243—
+7K233951CD Horizon ModuLeX Spinal System (Shanks, Head Assemblies, and Set Screw)Medtronic Sofamor Danek USA, Inc.20245—
+7K240507NuVasive AttraX ScaffoldNuvasive, Inc.20240—
+7K231850QUARTEX® Occipito-Cervico-Thoracic Spinal System ExcelsiusGPS® InstrumentsGlobus Medical, Inc.20242—
+7K240458Synthetic Bone PuttyVentris Medical20242—
+7K240459Cerament Bone Void FillerBonesupport AB20240—
+7K233508iFuse Bedrock Granite® Implant SystemSI-BONE, Inc.20245—
+7K232347MagnetOs GranulesKuros Biosciences B.V20242—
+7K233744Curiteva Porous PEEK Lumbar Interbody Fusion SystemCuriteva, Inc.20242—
+7K233944CarboClear® X Pedicle Screw System; CarboClear® X Navigated InstrumentsCarboFix Orthopedics, Ltd.20243—
+7K233839Peridot-PT Anterior Cervical Intervertebral body fusion System; Peridot-PT…Gbs Commonwealth Co., Ltd.20231—
+7K233607MagnetOs Easypack PuttyKuros Biosciences B.V20232—
+7K232877FaSet Fixation System, UNITY Sacroiliac Joint Fixation System, Huvex Interspinous…K&J Consulting Corporation20231—
+7K233490SIGNAFUSE Bioactive Strip (SBS); SIGNAFUSE PuttyBioventus, LLC20232—