510(k) Report

Devices descending from K040731

895 later devices reach Stryker Spine Vertebral Spacer through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+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—
+8K162103Choice Spine Lumbar Spacer System (Sabre™, Shark™, Hornet™, Harpoon™), Choice Spine…Choicespine, LP2016161—
+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—
+9K261284Invictus® Small Stature Spinal Fixation System; Invictus® 2.0 Spinal Fixation SystemAlphatec Spine, Inc.20260—
+9K261279DeltaNEC Interbody SystemNexus Spine20260—
+9K260810Anteralign LS coverplateTyber Medical, LLC20260—
+9K261159Exceed® Biplanar Expandable Interbody SystemSpine Wave, Inc.20260—
+9K253615Invictus Bands SystemAlphatec Spine, Inc.20260—
+9K254017SWINGO-3D Lumbar Cage SystemImplanet20260—
+9K252597Valence Robotic Navigation System; Valence Robotic Navigation Instruments (For Use with…Alphatec Spine, Inc.20261—
+9K253147FIBERGRAFT™ BG Putty GPS Bone Graft Substitute FIBERGRAFT™ BG Putty Bone Graft…Prosidyan, Inc.20250—
+9K243816Testa TP Pivoting Spacer SystemSpine Wave, Inc.20250—
+9K251003X-PAC® LLIF Expandable Lateral Cage SystemExpanding Innovations, Inc.20250—
+9K250602X-PAC® N-GAGE™ Lumbar Plate SystemExpanding Innovations, Inc.20250—
+9K251117Cervical Spine Truss System (CSTS)4Web Medical20250—
+9K250669Adaptix™ Interbody System with Titan nanoLOCK™ Surface TechnologyMedtronic Sofamor Danek USA, Inc.20250—
+9K250521NanoBone® SBX Putty ; NanoBone® QDBiocomposites, Ltd.20250—
+9K250667DeGen Medical Patient Specific Implant (PSI) SystemDegen Medical20251—
+9K250556Porous Biologic ScaffoldVentris Medical20250—
+9K243706Mastergraft Matrix EXT; Mastergraft Strip; Mastergraft Putty; Mastergraft GranulesMedtronic Sofamor Danek, Inc.20250—
+9K241167BioSphere Putty; BioSphere MIS PuttySynergy Biomedical20240—
+9K242350Spinal Alignment Solutions Pelvic Incidence (PI) Rod SystemSpinal Alignment Solutions, Inc.20241—
+9K242589Scarlet® AL-TSpineart SA20240—
+9K242299NovaBone Putty - Synthetic Bioactive Bone GraftNovabone Products, LLC20241—
+9K242273Cove Putty, OsteoCove PuttySeaSpine Orthopedics Corporation202402
+9K241892Cortera™ Spinal Fixation SystemXtant Medical Holdings, Inc.20242—
+9K240442MagnetOs PuttyKuros Biosciences B.V20243—
+9K240715Idys® C ZP 3DTiClariance20240—
+9K240507NuVasive AttraX ScaffoldNuvasive, Inc.20240—
+9K240458Synthetic Bone PuttyVentris Medical20242—
+9K240459Cerament Bone Void FillerBonesupport AB20240—
+9K232347MagnetOs GranulesKuros Biosciences B.V20242—
+9K233839Peridot-PT Anterior Cervical Intervertebral body fusion System; Peridot-PT…Gbs Commonwealth Co., Ltd.20231—
+9K233607MagnetOs Easypack PuttyKuros Biosciences B.V20232—
+9K233490SIGNAFUSE Bioactive Strip (SBS); SIGNAFUSE PuttyBioventus, LLC20232—
+9K233245MagnetOs Flex MatrixKuros Biosciences B.V20230—
+9K232345ATEC Posterior Navigated Disc Prep InstrumentsAlphatec Spine, Inc.20232—
+9K230927OptiMesh Multiplanar Expandable Interbody Fusion SystemSpineology, Inc.20231—
+9K232044Invictus Robotic Navigation InstrumentsAlphatec Spine, Inc.20233—
+9K232275Invictus® Spinal Fixation SystemAlphatec Spine, Inc.202311—
+9K232315Catalyst Bone Void FillerOssdsign AB20237—
+9K230721ATEC Lateral Plate SystemAlphatec Spine, Inc.20230—
+9K223231Ti-Largo Cervical Interbody SystemFlospine20230—
+9K223494CD Horizon Spinal SystemMedtronic202317—
+9K223731NuVasive Modulus-C Interbody SystemNuvasive, Inc.202311—
+9K223671CONDUIT LLIF Straight InsertersEnztec Limited20231—
+9K223153Catalyft LS Expandable Interbody System with Titan nanoLOCK Surface TechnologyMedtronic Sofamor Danek USA, Inc.20220—
+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—
+9K213951FORZA XP Expandable Spacer SystemOrthofix US, LLC20224—
+9K213460Invictus Spinal Fixation SystemAlphatec Spine, Inc.202117—
+9K212967AxTiHA Stand-Alone ALIF SystemInnovasis, Inc.20211—
+9K210590Axis Spine Technologies ALIFAxis Spine Technologies, Ltd.20210—
+9K210425Catalyft PL Expandable Interbody SystemMedtronic Sofamor Danek USA, Inc.2021561
+9K201024Expandable Titanium PLIF/TLIF SystemSpectrum Spine, LLC20215—
+9K203342CONSTRUX Mini Ti Spacer SystemOrthofix, Inc.202191
+9K203576FORZA Ti Spacer SystemOrthofix, Inc.202161
+9K202666CONSTRUX Mini PTC Spacer SystemOrthofix, Inc.202010—
+9K200352Axis Spine Technologies ALIFAxis Spine Technologies, Ltd.20202—
+9K200338ProLift Lateral FixatedLife Spine, Inc.20205—
+9K193593NuVasive 3DP Interfixated ALIF SystemNu Vasive, Incorporated2020157—
+9K192993Scarlet AL-TSpineart20201—
+9K191834Stand-Alone ALIF Titanium SystemLife Spine, Inc.20190—
+9K191339Zavation eZspand Interbody SystemZavation Medical Products, LLC20195—
+9K191100ExcelsiusGPS Spine 1.1 Interbody ModuleGlobus Medical, Inc.201942—
+9K182158UNiD Patient-matched PLIF cageMedicrea International SA201921—
+9K190877Juliet® Ti LL Lumbar Interbody DeviceSpineart201911
+9K191091Rampart One Lumbar Interbody Fusion SystemSpineology, Inc.20191—
+9K190092UNiD Patient specific 3D printed TLIF cageMedicrea International SA201913—
+9K182114FlareHawk Interbody Fusion SystemIntegrity Implants, Inc.20196—
+9K181397DualXInnovasive, Inc.201815—
+9K180891EVOL Spinal Interbody System, EVOS Lumbar Interbody SystemCutting Edge Spine, LLC20181—
+9K173782UNiD Patient Specific 3D printed cageMedicrea International SA201823—
+9K172816TiGer Shark™ SystemChoicespine, LP201859—
+9K172328SOVEREIGN™ Spinal SystemMedtronic Sofamor Danek USA, Inc.201730—
+9K171689ARTiC-L 3D Ti Spinal System with TiONIC Technology, ARTiC-XL 3D Ti Spinal System with…Medtronic Sofamor Danek USA, Inc.2017109—
+9K171686Choice Spine Hawkeye™ Vertebral Body Replacement (VBR) SystemChoicespine2017116—
+9K163670Rampart One Lumbar Interbody Fusion DeviceSpineology, Inc.20173—
+9K170643Interbody Fusion (IBF)/Vertebral Body Replacement (VBR) SystemRti Surgical, Inc. Dba Rti Biologics201711—
+9K163409Rampart (TM) T Lumbar Interbody Fusion DeviceSpineology, Inc.20170—
+9K162879Elite Expandable Interbody Fusion DeviceSpineology, Inc.20179—
+9K162351SeaSpine® Vu a•POD™ Prime NanoMetalene® Intervertebral Body Fusion DeviceSeaSpine Orthopedics Corporation201679—
+10K263172SAS MIS Pelvic Incidence RodsSpinal Alignment Solutions, Inc.20260—
+10K262230Mg OSTEOREVIVE™;Mg OSTEOCRETE™Bone Solutions, Inc.20260—