510(k) Report

Devices descending from K033837

896 later devices reach Stryker Spine Vertebral Body Support System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+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—
+9K162103Choice Spine Lumbar Spacer System (Sabre™, Shark™, Hornet™, Harpoon™), Choice Spine…Choicespine, LP2016161—
+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—
+10K261284Invictus® Small Stature Spinal Fixation System; Invictus® 2.0 Spinal Fixation SystemAlphatec Spine, Inc.20260—
+10K261279DeltaNEC Interbody SystemNexus Spine20260—
+10K260810Anteralign LS coverplateTyber Medical, LLC20260—
+10K261159Exceed® Biplanar Expandable Interbody SystemSpine Wave, Inc.20260—
+10K253615Invictus Bands SystemAlphatec Spine, Inc.20260—
+10K254017SWINGO-3D Lumbar Cage SystemImplanet20260—
+10K252597Valence Robotic Navigation System; Valence Robotic Navigation Instruments (For Use with…Alphatec Spine, Inc.20261—
+10K253147FIBERGRAFT™ BG Putty GPS Bone Graft Substitute FIBERGRAFT™ BG Putty Bone Graft…Prosidyan, Inc.20250—
+10K243816Testa TP Pivoting Spacer SystemSpine Wave, Inc.20250—
+10K251003X-PAC® LLIF Expandable Lateral Cage SystemExpanding Innovations, Inc.20250—
+10K250602X-PAC® N-GAGE™ Lumbar Plate SystemExpanding Innovations, Inc.20250—
+10K251117Cervical Spine Truss System (CSTS)4Web Medical20250—
+10K250669Adaptix™ Interbody System with Titan nanoLOCK™ Surface TechnologyMedtronic Sofamor Danek USA, Inc.20250—
+10K250521NanoBone® SBX Putty ; NanoBone® QDBiocomposites, Ltd.20250—
+10K250667DeGen Medical Patient Specific Implant (PSI) SystemDegen Medical20251—
+10K250556Porous Biologic ScaffoldVentris Medical20250—
+10K243706Mastergraft Matrix EXT; Mastergraft Strip; Mastergraft Putty; Mastergraft GranulesMedtronic Sofamor Danek, Inc.20250—
+10K241167BioSphere Putty; BioSphere MIS PuttySynergy Biomedical20240—
+10K242350Spinal Alignment Solutions Pelvic Incidence (PI) Rod SystemSpinal Alignment Solutions, Inc.20241—
+10K242589Scarlet® AL-TSpineart SA20240—
+10K242299NovaBone Putty - Synthetic Bioactive Bone GraftNovabone Products, LLC20241—
+10K242273Cove Putty, OsteoCove PuttySeaSpine Orthopedics Corporation202402
+10K241892Cortera™ Spinal Fixation SystemXtant Medical Holdings, 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—
+10K233839Peridot-PT Anterior Cervical Intervertebral body fusion System; Peridot-PT…Gbs Commonwealth Co., Ltd.20231—
+10K233607MagnetOs Easypack PuttyKuros Biosciences B.V20232—
+10K233490SIGNAFUSE Bioactive Strip (SBS); SIGNAFUSE PuttyBioventus, LLC20232—
+10K233245MagnetOs Flex MatrixKuros Biosciences B.V20230—
+10K232345ATEC Posterior Navigated Disc Prep InstrumentsAlphatec Spine, Inc.20232—
+10K230927OptiMesh Multiplanar Expandable Interbody Fusion SystemSpineology, Inc.20231—
+10K232044Invictus Robotic Navigation InstrumentsAlphatec Spine, Inc.20233—
+10K232275Invictus® Spinal Fixation SystemAlphatec Spine, Inc.202311—
+10K232315Catalyst Bone Void FillerOssdsign AB20237—
+10K230721ATEC Lateral Plate SystemAlphatec Spine, Inc.20230—
+10K223231Ti-Largo Cervical Interbody SystemFlospine20230—
+10K223494CD Horizon Spinal SystemMedtronic202317—
+10K223731NuVasive Modulus-C Interbody SystemNuvasive, Inc.202311—
+10K223671CONDUIT LLIF Straight InsertersEnztec Limited20231—
+10K223153Catalyft LS Expandable Interbody System with Titan nanoLOCK Surface TechnologyMedtronic Sofamor Danek USA, Inc.20220—
+10K221180Anteralign (TM) Spinal System with Titan NanoLOCK Surface Technology Navigated InstrumentsMedtronic Sofamor Danek USA, Inc.20222—
+10K214011Catalyft™ PL Expandable Interbody System Navigated Instruments, Anteralign™ TL Spinal…Medtronic Sofamor Danek USA, Inc.20221—
+10K213951FORZA XP Expandable Spacer SystemOrthofix US, LLC20224—
+10K213460Invictus Spinal Fixation SystemAlphatec Spine, Inc.202117—
+10K212967AxTiHA Stand-Alone ALIF SystemInnovasis, Inc.20211—
+10K210590Axis Spine Technologies ALIFAxis Spine Technologies, Ltd.20210—
+10K210425Catalyft PL Expandable Interbody SystemMedtronic Sofamor Danek USA, Inc.2021561
+10K201024Expandable Titanium PLIF/TLIF SystemSpectrum Spine, LLC20215—
+10K203342CONSTRUX Mini Ti Spacer SystemOrthofix, Inc.202191
+10K203576FORZA Ti Spacer SystemOrthofix, Inc.202161
+10K202666CONSTRUX Mini PTC Spacer SystemOrthofix, Inc.202010—
+10K200352Axis Spine Technologies ALIFAxis Spine Technologies, Ltd.20202—
+10K200338ProLift Lateral FixatedLife Spine, Inc.20205—
+10K193593NuVasive 3DP Interfixated ALIF SystemNu Vasive, Incorporated2020157—
+10K192993Scarlet AL-TSpineart20201—
+10K191834Stand-Alone ALIF Titanium SystemLife Spine, Inc.20190—
+10K191339Zavation eZspand Interbody SystemZavation Medical Products, LLC20195—
+10K191100ExcelsiusGPS Spine 1.1 Interbody ModuleGlobus Medical, Inc.201942—
+10K182158UNiD Patient-matched PLIF cageMedicrea International SA201921—
+10K190877Juliet® Ti LL Lumbar Interbody DeviceSpineart201911
+10K191091Rampart One Lumbar Interbody Fusion SystemSpineology, Inc.20191—
+10K190092UNiD Patient specific 3D printed TLIF cageMedicrea International SA201913—
+10K182114FlareHawk Interbody Fusion SystemIntegrity Implants, Inc.20196—
+10K181397DualXInnovasive, Inc.201815—
+10K180891EVOL Spinal Interbody System, EVOS Lumbar Interbody SystemCutting Edge Spine, LLC20181—
+10K173782UNiD Patient Specific 3D printed cageMedicrea International SA201823—
+10K172816TiGer Shark™ SystemChoicespine, LP201859—
+10K172328SOVEREIGN™ Spinal SystemMedtronic Sofamor Danek USA, Inc.201730—
+10K171689ARTiC-L 3D Ti Spinal System with TiONIC Technology, ARTiC-XL 3D Ti Spinal System with…Medtronic Sofamor Danek USA, Inc.2017109—
+10K171686Choice Spine Hawkeye™ Vertebral Body Replacement (VBR) SystemChoicespine2017116—
+10K163670Rampart One Lumbar Interbody Fusion DeviceSpineology, Inc.20173—
+10K170643Interbody Fusion (IBF)/Vertebral Body Replacement (VBR) SystemRti Surgical, Inc. Dba Rti Biologics201711—
+10K163409Rampart (TM) T Lumbar Interbody Fusion DeviceSpineology, Inc.20170—
+10K162879Elite Expandable Interbody Fusion DeviceSpineology, Inc.20179—
+10K162351SeaSpine® Vu a•POD™ Prime NanoMetalene® Intervertebral Body Fusion DeviceSeaSpine Orthopedics Corporation201679—
+11K263172SAS MIS Pelvic Incidence RodsSpinal Alignment Solutions, Inc.20260—