510(k) Report

Devices descending from K031302

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

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+9K233951CD Horizon ModuLeX Spinal System (Shanks, Head Assemblies, and Set Screw)Medtronic Sofamor Danek USA, Inc.20245—
+9K233508iFuse Bedrock Granite® Implant SystemSI-BONE, Inc.20245—
+9K230872Halis™ Lumbar Cage System, Lydia™ Anterior Lumbar Fusion System, Dica™ Direction…Shanghai Sanyou Medical Co, Ltd.20231—
+9K233084Peridot-PT Anterior Cervical Intervertebral body fusion System, Peridot-PT…Gbs Commonwealth Co., Ltd.20232—
+9K232345ATEC Posterior Navigated Disc Prep InstrumentsAlphatec Spine, Inc.20232—
+9K231739Cervical Spine Truss System (CSTS)4Web Medical, Inc.20232—
+9K232154MiRus 3DR Lateral Lumbar Interbody Fusion System with Integrated Plate FixationMiRus, LLC20230—
+9K231275Exceed™ Biplanar Expandable Interbody SystemSpine Wave, Inc.20232—
+9K223335SIRION Lateral Lumbar Interbody SystemAstura Medical20230—
+9K223688CONDUIT™ Lateral Lumbar Intervertebral Fusion Cage, CONDUIT™ InstrumentsMedos International Sàrl20230—
+9K223153Catalyft LS Expandable Interbody System with Titan nanoLOCK Surface TechnologyMedtronic Sofamor Danek USA, Inc.20220—
+9K221751NuVasive Cohere ALIF System Intervertebral Body Fusion DeviceNu Vasive, Incorporated20223—
+9K222276CONDUIT Cages; FIBERGRAFT BG PuttyDepuy Spine202229—
+9K221325CONDUIT Lateral Switch PlateMedos International SARL20221—
+9K220449DePuy CONDUIT LLIF SQUID InserterEnztec Limited20220—
+9K220478NuVasive MOD-EX XLIF Interbody System, NuVasive MOD-EX XLIF Plated 2.0 Interbody SystemNu Vasive, Incorporated20222—
+9K221180Anteralign (TM) Spinal System with Titan NanoLOCK Surface Technology Navigated InstrumentsMedtronic Sofamor Danek USA, Inc.20222—
+9K214006Invictus® Spinal Fixation SystemAlphatec Spine, Inc.202216—
+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—
+9K212823DePuy CONDUIT LLIF Angled InsertersEnztec Limited20213—
+9K212562Idys-C ZP 3DTiClariance, SA20211—
+9K201793EDEN Peek CageJmt Co., Ltd.20210—
+9K211704CONSTRUX Mini PEEK Spacer System/CONSTRUX Mini PEEK VBR System, CONSTRUX Mini PTC Spacer…Orthofix, Inc.20215—
+9K211388Lateral Spine Truss System (LSTS) Interbody Fusion Device4Web Medical, Inc.20210—
+9K210425Catalyft PL Expandable Interbody SystemMedtronic Sofamor Danek USA, Inc.2021561
+9K210728CONDUIT InstrumentsMedos International SARL20215—
+9K210271NuVasive Modulus ALIF SystemNu Vasive, Incorporated20215—
+9K200549Lucero Medical Cervical Cage SystemLucero Medical, LLC20200—
+9K202230NEXXT MATRIXX Stand Alone ALIF SystemNexxt Spine, LLC20200—
+9K202587ATEC Lateral Interbody SystemAlphatec Spine, Inc.202039—
+9K200316UNiD IB3D ALIFMedicrea International SA20200—
+9K202949CONSTRUX Mini PEEK Spacer SystemOrthofix, Inc.20206—
+9K201614TxTiHA IBF System, AxTiHA Stand-Alone ALIF SystemInnovasis, Inc.2020471
+9K200052CONSTRUX Mini PTC Spacer System, FORZA PTC Spacer System, PILLAR SA PTC Spacer SystemOrthofix, Inc.202013—
+9K193359SureMAX Family of Cervical SpacersAdditive Implants, Inc.202014—
+9K192938Invictus™ Spinal Fixation SystemAlphatec Spine, Inc.201969—
+9K192026Peridot Intervertebral body fusion SystemGbs Commonwealth Co., Ltd.20196—
+9K190483SPIRA Open Matrix ALIF and LLIFCamber Spine Technologies20199—
+9K183560Luna 3D GEN2 Interbody Fusion SystemBenvenue Medical, Inc.20192—
+9K190067Velofix Interbody Fusion SystemU&I Corporation20193—
+9K182746ATEC ALIF and LLIF Spacer SystemAlphatec Spine, Inc.2018110—
+9K181818Scarlet AL-TSpineart201864—
+9K181591Fixated Asfora BULLET CAGE® (FABC)Medical Designs, LLC20180—
+9K180215DYNA-LINK ELITE Stand-Alone Anterior Lumbar SystemLife Spine, Inc.20182—
+9K180963Roccia Alif, Roccia TlifSilony Medical GmbH20183—
+9K180002Rampart One Lumbar Interbody Fusion DeviceSpineology, Inc.20182—
+9K172696FORZA® XP Expandable Spacer SystemOrthofix, Inc.201825—
+9K163595IMPIX 3D Print CagesMedicrea International SA2017282
+9K170395Talos® Lumbar (HA) PEEK IBF DevicesMeditech Spine, LLC201710—
+9K170592NuVasive BASE Interfixated Titanium SystemNu Vasive, Incorporated2017186—
+9K160924Amendia Interbody Fusion DevicesAmendia, Inc.2016166—
+9K162944Irix-C Cervical Integrated Fusion SystemX-Spine Systems, Inc.20161—
+9K162358T-PAL Spacer System, T-PAL Titanium Spacer System, SYNFIX Evolution SystemSynthes USA Products, LLC2016127—
+9K161379ELSA SpacersGlobus Medical, Inc.2016155—
+9K161173Avenue® T TLIF CageLdr Spine USA, Inc.20163—
+9K160597INDEPENDENCE MIS SpacersGlobus Medical, Inc.2016111—
+9K160906Rampart O Lumbar Interbody Fusion Device, Rampart T Lumbar Interbody Fusion Device…Spineology, Inc.201627—
+9K152622Alta ACDF SystemBiomet Spine20160—
+9K152943NuVasive Foundation-LL SystemNu Vasive, Incorporated2015187—
+10K262067iFuse Granite Onyx™ Implant SystemSI-BONE, Inc.20260—
+10K261159Exceed® Biplanar Expandable Interbody SystemSpine Wave, Inc.20260—
+10K254274ARx® SAI Implant SystemLife Spine, Inc.20260—
+10K260340HC Biologics Osteopoint Peek Cages, HC Biologics Osteopoint Cervical Peek Cages, HC…HC Biologics, LLC20260—
+10K254017SWINGO-3D Lumbar Cage SystemImplanet20260—
+10K252597Valence Robotic Navigation System; Valence Robotic Navigation Instruments (For Use with…Alphatec Spine, Inc.20261—
+10K252742Navigated InstrumentsTyber Medical, LLC20251—
+10K253147FIBERGRAFT™ BG Putty GPS Bone Graft Substitute FIBERGRAFT™ BG Putty Bone Graft…Prosidyan, Inc.20250—
+10K252322SIros-X SystemGenesys Spine20250—
+10K253094iFuse Bedrock Granite Implant SystemSI-BONE, Inc.20250—
+10K243816Testa TP Pivoting Spacer SystemSpine Wave, Inc.20250—
+10K251117Cervical Spine Truss System (CSTS)4Web Medical20250—
+10K250521NanoBone® SBX Putty ; NanoBone® QDBiocomposites, Ltd.20250—
+10K250556Porous Biologic ScaffoldVentris Medical20250—
+10K243706Mastergraft Matrix EXT; Mastergraft Strip; Mastergraft Putty; Mastergraft GranulesMedtronic Sofamor Danek, Inc.20250—
+10K241167BioSphere Putty; BioSphere MIS PuttySynergy Biomedical20240—
+10K242589Scarlet® AL-TSpineart SA20240—
+10K243007CD Horizon™ Spinal SystemMedtronic Sofamor Danek USA, Inc.20243—
+10K242299NovaBone Putty - Synthetic Bioactive Bone GraftNovabone Products, LLC20241—
+10K242273Cove Putty, OsteoCove PuttySeaSpine Orthopedics Corporation202402
+10K241464ARx® SAI Implant SystemLife Spine, Inc.20241—
+10K241519Invictus® Small Stature Spinal Fixation SystemAlphatec Spine, Inc.20242—
+10K240442MagnetOs PuttyKuros Biosciences B.V20243—
+10K240715Idys® C ZP 3DTiClariance20240—
+10K240507NuVasive AttraX ScaffoldNuvasive, Inc.20240—
+10K240458Synthetic Bone PuttyVentris Medical20242—
+10K240459Cerament Bone Void FillerBonesupport AB20240—
+10K232347MagnetOs GranulesKuros Biosciences B.V20242—
+10K233607MagnetOs Easypack PuttyKuros Biosciences B.V20232—
+10K233490SIGNAFUSE Bioactive Strip (SBS); SIGNAFUSE PuttyBioventus, LLC20232—
+10K233245MagnetOs Flex MatrixKuros Biosciences B.V20230—
+10K230927OptiMesh Multiplanar Expandable Interbody Fusion SystemSpineology, Inc.20231—
+10K231076VariLift®-C Interbody Fusion SystemWenzel Spine, Inc.20234—
+10K232315Catalyst Bone Void FillerOssdsign AB20237—
+10K223231Ti-Largo Cervical Interbody SystemFlospine20230—
+10K223731NuVasive Modulus-C Interbody SystemNuvasive, Inc.202311—
+10K223671CONDUIT LLIF Straight InsertersEnztec Limited20231—
+10K221926Invictus® Bone Cement, Invictus Spinal Fixation SystemAlphatec Spine, Inc.202214—
+10K222383Anteralign™ LS Spinal System with Titan nanoLOCK™ Surface Technology MAZORX Stealth (TM)…Medtronic Sofamor Danek USA, Inc.20220—
+10K221403Cortera Spinal Fixation SystemSurgalign Spine Technologies202232