510(k) Report

Devices descending from K040284

906 later devices reach Sustain Radiolucent Spacer through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+8K220478NuVasive MOD-EX XLIF Interbody System, NuVasive MOD-EX XLIF Plated 2.0 Interbody SystemNu Vasive, Incorporated20222—
+8K221180Anteralign (TM) Spinal System with Titan NanoLOCK Surface Technology Navigated InstrumentsMedtronic Sofamor Danek USA, Inc.20222—
+8K214006Invictus® Spinal Fixation SystemAlphatec Spine, Inc.202216—
+8K214011Catalyft™ PL Expandable Interbody System Navigated Instruments, Anteralign™ TL Spinal…Medtronic Sofamor Danek USA, Inc.20221—
+8K203714NuVasive Thoracolumbar Interbody Systems: NuVasive CoRoent Thoracolumbar System…Nu Vasive, Incorporated202166—
+8K212823DePuy CONDUIT LLIF Angled InsertersEnztec Limited20213—
+8K212562Idys-C ZP 3DTiClariance, SA20211—
+8K201793EDEN Peek CageJmt Co., Ltd.20210—
+8K211704CONSTRUX Mini PEEK Spacer System/CONSTRUX Mini PEEK VBR System, CONSTRUX Mini PTC Spacer…Orthofix, Inc.20215—
+8K211388Lateral Spine Truss System (LSTS) Interbody Fusion Device4Web Medical, Inc.20210—
+8K210425Catalyft PL Expandable Interbody SystemMedtronic Sofamor Danek USA, Inc.2021561
+8K210728CONDUIT InstrumentsMedos International SARL20215—
+8K210271NuVasive Modulus ALIF SystemNu Vasive, Incorporated20215—
+8K200549Lucero Medical Cervical Cage SystemLucero Medical, LLC20200—
+8K202230NEXXT MATRIXX Stand Alone ALIF SystemNexxt Spine, LLC20200—
+8K202587ATEC Lateral Interbody SystemAlphatec Spine, Inc.202039—
+8K200316UNiD IB3D ALIFMedicrea International SA20200—
+8K202949CONSTRUX Mini PEEK Spacer SystemOrthofix, Inc.20206—
+8K201614TxTiHA IBF System, AxTiHA Stand-Alone ALIF SystemInnovasis, Inc.2020471
+8K200052CONSTRUX Mini PTC Spacer System, FORZA PTC Spacer System, PILLAR SA PTC Spacer SystemOrthofix, Inc.202013—
+8K193359SureMAX Family of Cervical SpacersAdditive Implants, Inc.202014—
+8K192938Invictus™ Spinal Fixation SystemAlphatec Spine, Inc.201969—
+8K192026Peridot Intervertebral body fusion SystemGbs Commonwealth Co., Ltd.20196—
+8K190483SPIRA Open Matrix ALIF and LLIFCamber Spine Technologies20199—
+8K183560Luna 3D GEN2 Interbody Fusion SystemBenvenue Medical, Inc.20192—
+8K190067Velofix Interbody Fusion SystemU&I Corporation20193—
+8K182746ATEC ALIF and LLIF Spacer SystemAlphatec Spine, Inc.2018110—
+8K181818Scarlet AL-TSpineart201864—
+8K181591Fixated Asfora BULLET CAGE® (FABC)Medical Designs, LLC20180—
+8K180215DYNA-LINK ELITE Stand-Alone Anterior Lumbar SystemLife Spine, Inc.20182—
+8K180963Roccia Alif, Roccia TlifSilony Medical GmbH20183—
+8K180002Rampart One Lumbar Interbody Fusion DeviceSpineology, Inc.20182—
+8K172696FORZA® XP Expandable Spacer SystemOrthofix, Inc.201825—
+8K163595IMPIX 3D Print CagesMedicrea International SA2017282
+8K170395Talos® Lumbar (HA) PEEK IBF DevicesMeditech Spine, LLC201710—
+8K170592NuVasive BASE Interfixated Titanium SystemNu Vasive, Incorporated2017186—
+8K160924Amendia Interbody Fusion DevicesAmendia, Inc.2016166—
+8K162944Irix-C Cervical Integrated Fusion SystemX-Spine Systems, Inc.20161—
+8K162358T-PAL Spacer System, T-PAL Titanium Spacer System, SYNFIX Evolution SystemSynthes USA Products, LLC2016127—
+8K161379ELSA SpacersGlobus Medical, Inc.2016155—
+8K161173Avenue® T TLIF CageLdr Spine USA, Inc.20163—
+8K160597INDEPENDENCE MIS SpacersGlobus Medical, Inc.2016111—
+8K160906Rampart O Lumbar Interbody Fusion Device, Rampart T Lumbar Interbody Fusion Device…Spineology, Inc.201627—
+8K152622Alta ACDF SystemBiomet Spine20160—
+8K152943NuVasive Foundation-LL SystemNu Vasive, Incorporated2015187—
+9K263172SAS MIS Pelvic Incidence RodsSpinal Alignment Solutions, Inc.20260—
+9K262067iFuse Granite Onyx™ Implant SystemSI-BONE, Inc.20260—
+9K261159Exceed® Biplanar Expandable Interbody SystemSpine Wave, Inc.20260—
+9K260989Varion Thoracolumbar Fixation SystemKyocera Medical Technologies Inc. (KMTI)20260—
+9K252542LEO Spinal SystemZheJiang Decans Medical Devices Co., Ltd.20260—
+9K260216CD Horizon™ ModuLeX™ Fenestrated Screw Set; CD Horizon™ ModuLeX™ Spinal SystemMedtronic Sofamor Danek USA, Inc.20260—
+9K260011Foundation Surgical Navigated Lateral Disc Prep InstrumentsFoundation Surgical Group, Inc.20260—
+9K260340HC Biologics Osteopoint Peek Cages, HC Biologics Osteopoint Cervical Peek Cages, HC…HC Biologics, LLC20260—
+9K254017SWINGO-3D Lumbar Cage SystemImplanet20260—
+9K252597Valence Robotic Navigation System; Valence Robotic Navigation Instruments (For Use with…Alphatec Spine, Inc.20261—
+9K252742Navigated InstrumentsTyber Medical, LLC20251—
+9K253335CD Horizon™ Spinal SystemMedtronic Sofamor Danek USA, Inc.20250—
+9K253147FIBERGRAFT™ BG Putty GPS Bone Graft Substitute FIBERGRAFT™ BG Putty Bone Graft…Prosidyan, Inc.20250—
+9K253331PressON Spinal Fixation SystemNexus Spine20250—
+9K243816Testa TP Pivoting Spacer SystemSpine Wave, Inc.20250—
+9K251117Cervical Spine Truss System (CSTS)4Web Medical20250—
+9K250521NanoBone® SBX Putty ; NanoBone® QDBiocomposites, Ltd.20250—
+9K250556Porous Biologic ScaffoldVentris Medical20250—
+9K243706Mastergraft Matrix EXT; Mastergraft Strip; Mastergraft Putty; Mastergraft GranulesMedtronic Sofamor Danek, Inc.20250—
+9K241167BioSphere Putty; BioSphere MIS PuttySynergy Biomedical20240—
+9K242589Scarlet® AL-TSpineart SA20240—
+9K242299NovaBone Putty - Synthetic Bioactive Bone GraftNovabone Products, LLC20241—
+9K242273Cove Putty, OsteoCove PuttySeaSpine Orthopedics Corporation202402
+9K241519Invictus® Small Stature Spinal Fixation SystemAlphatec Spine, Inc.20242—
+9K241082INNOVERSE Navigation InstrumentsInnosys Co., Ltd.20240—
+9K240442MagnetOs PuttyKuros Biosciences B.V20243—
+9K233951CD Horizon ModuLeX Spinal System (Shanks, Head Assemblies, and Set Screw)Medtronic Sofamor Danek USA, Inc.20245—
+9K240715Idys® C ZP 3DTiClariance20240—
+9K240507NuVasive AttraX ScaffoldNuvasive, Inc.20240—
+9K240458Synthetic Bone PuttyVentris Medical20242—
+9K240459Cerament Bone Void FillerBonesupport AB20240—
+9K233508iFuse Bedrock Granite® Implant SystemSI-BONE, Inc.20245—
+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—
+9K231076VariLift®-C Interbody Fusion SystemWenzel Spine, Inc.20234—
+9K232315Catalyst Bone Void FillerOssdsign AB20237—
+9K223231Ti-Largo Cervical Interbody SystemFlospine20230—
+9K223731NuVasive Modulus-C Interbody SystemNuvasive, Inc.202311—
+9K223671CONDUIT LLIF Straight InsertersEnztec Limited20231—
+9K221926Invictus® Bone Cement, Invictus Spinal Fixation SystemAlphatec Spine, Inc.202214—
+9K222383Anteralign™ LS Spinal System with Titan nanoLOCK™ Surface Technology MAZORX Stealth (TM)…Medtronic Sofamor Danek USA, Inc.20220—
+9K221403Cortera Spinal Fixation SystemSurgalign Spine Technologies202232
+9K213980Peridot Spinal Interbody SystemGbs Commonwealth Co., Ltd.20224—
+9K213951FORZA XP Expandable Spacer SystemOrthofix US, LLC20224—
+9K212967AxTiHA Stand-Alone ALIF SystemInnovasis, Inc.20211—
+9K210590Axis Spine Technologies ALIFAxis Spine Technologies, Ltd.20210—
+9K201024Expandable Titanium PLIF/TLIF SystemSpectrum Spine, LLC20215—
+9K203342CONSTRUX Mini Ti Spacer SystemOrthofix, Inc.202191
+9K203576FORZA Ti Spacer SystemOrthofix, Inc.202161
+9K202872Prase PEEK Anterior Cervical Interbody SpacerGbs Commonwealth Co., Ltd.20215—
+9K203327VERTACONNECT TLIF CageSignus Medizintechnik20210—
+9K203125Invictus™ OCT Spinal Fixation SystemAlphatec Spine, Inc.20200—