510(k) Report

Devices descending from K020152

1,684 later devices reach Synthes Vertebral Spacer TI through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+9K252351UniSpace® TPLIF CageCg Medtech Co., Ltd.20250—
+9K253147FIBERGRAFT™ BG Putty GPS Bone Graft Substitute FIBERGRAFT™ BG Putty Bone Graft…Prosidyan, Inc.20250—
+9K251719Momentum® Posterior Spinal Fixation SystemUlrich Medical USA, Inc.20250—
+9K242464Stealth™ Spine Clamps; ModuLeX™ Shank MountsMedtronic Navigation, Inc.20251—
+9K243474MagnetOs MISKuros Biosciences B.V20250—
+9K251117Cervical Spine Truss System (CSTS)4Web Medical20250—
+9K250373ProLift Expandable Spacer SystemLife Spine, Inc.20251—
+9K243915FIX-C 3D Ti ACIF SystemJeil Medical Corporation20250—
+9K243668ProLift Pivot Expandable Spacer SystemLife Spine, Inc.20250—
+9K242797OsteoFlo HydroFiberSurGenTec, LLC20241—
+9K242734ZSFab Cervical Interbody System; ZSFab Lumbar Interbody SystemZsfab20243—
+9K242195Gemini Cervical Fusion Cage SystemZheJiang Decans Medical Devices Co., Ltd.20241—
+9K241992Catalyft™ LS Expandable Interbody SystemMedtronic Sofamor Danek USA, Inc.20240—
+9K242350Spinal Alignment Solutions Pelvic Incidence (PI) Rod SystemSpinal Alignment Solutions, Inc.20241—
+9K240889ARTFX Lumbar PEEK CagesArtfx Medical20244—
+9K241738PYXIS 3D Titanium Cervical Cage systemGS Medical Co., Ltd.20241—
+9K241564Actifuse ABX; Actifuse MIS; Actifuse Shape; ALTAPORE; ALTAPORE SHAPE; ALTAPORE MISBaxter Healthcare Corporation20240—
+9K240893ARTFX MEDICAL Cervical PEEK CagesArtfx Medical20244—
+9K241212MagnetOs Easypack PuttyKuros Biosciences20241—
+9K241519Invictus® Small Stature Spinal Fixation SystemAlphatec Spine, Inc.20242—
+9K240951Invictus Robotic Navigation InstrumentsAlphatec Spine20242—
+9K233966Anterior Spine Truss System-Stand Alone (ASTS-SA)4Web Medical, Inc.20241—
+9K234119UniSpace® Stand-Alone C CageInnosys Co., Ltd.20241—
+9K234150Lucent® XPSpinal Elements20240—
+9K240424Mineral Collagen Composite Bioactive Moldable Bone Graft MatrixCollagen Matrix, Inc.20240—
+9K233075“BioGend” Interbody Fusion System 001 CageBiogend Therapeutics Co., Ltd.20240—
+9K240453ReBOSSISOrthorebirth Co., Ltd.202402
+9K234013Mg OSTEOINJECT™; Mg OSTEOREVIVE™; Mg OSTEOCRETE™Bone Solutions, Inc.20243—
+9K230872Halis™ Lumbar Cage System, Lydia™ Anterior Lumbar Fusion System, Dica™ Direction…Shanghai Sanyou Medical Co, Ltd.20231—
+9K232611TruLift Micro Expandable Spacer System & TruLift Expandable Spacer SystemLife Spine, Inc.20232—
+9K233084Peridot-PT Anterior Cervical Intervertebral body fusion System, Peridot-PT…Gbs Commonwealth Co., Ltd.20232—
+9K231899HAtetracell™-C Titanium Cervical IBF SystemInnovasis, Inc.20232—
+9K223869ChoiceSpine Blackhawk Ti Cervical Spacer SystemChoice Spine, LLC20232—
+9K231680AccelFix Lumbar Expandable Cage SystemL&K BIOMED Co., Ltd.20231—
+9K231808QUASAR Standalone ACIF SystemGS Medical Co., Ltd.20230—
+9K222684XIA® 4.5 Spinal System, XIA® 4.5 Cortical Trajectory, XIA® 3 Spinal System, Serrato®…Stryker Spine20234—
+9K222833Ventana™ C Spinal SystemSpinal Elements, Inc.20234—
+9K220261NEST-C Interbody SystemPaonan Biotech Co., Ltd.20230—
+9K212612Omnia Medical TiBrid-SCOmnia Medical, LLC20220—
+9K221403Cortera Spinal Fixation SystemSurgalign Spine Technologies202232
+9K220449DePuy CONDUIT LLIF SQUID InserterEnztec Limited20220—
+9K212715Vy Spine ClariVy Cervical IBF SystemVy Spine, LLC20216—
+9K213115CHENA-C Spacer SystemKahtnu Surgical, Inc.20210—
+9K212823DePuy CONDUIT LLIF Angled InsertersEnztec Limited20213—
+9K211689KEYSTONE PEEK Cage SystemShanghai Sanyou Medical Co, Ltd.20212—
+9K210963ENNOVATE Spinal SystemAesculap Implant Systems, LLC20210—
+9K211442StealthStation Spinous Process ClampsMedtronic Navigation20212—
+9K210728CONDUIT InstrumentsMedos International SARL20215—
+9K200919Idys ALIF 3DTiClariance20210—
+9K210155Duo Expandable Interbody Fusion SystemSpineology, Inc.20210—
+9K203531XYPAN Expandable Lumbar Cage SystemAegis Spine, Inc.20213—
+9K202298Lucent XP, Lucent XP CurvedSpinal Elements, Inc.20202—
+9K203125Invictus™ OCT Spinal Fixation SystemAlphatec Spine, Inc.20200—
+9K203056Invictus™ Spinal Fixation SystemAlphatec Spine, Inc.202061—
+9K202327Invictus™ OsseoScrew® SystemAlphatec Spine, Inc.20200—
+9K200920Idys ALIF ZP 3DTiClariance, Sas20203—
+9K200936Invictus™ CT Spinal Fixation SystemAlphatec Spine, Inc.20203—
+9K200991EVOL Spinal Interbody SystemCutting Edge Spine, LLC20200—
+9K200552EVOS Lumbar Interbody SystemCutting Edge Spine, LLC20200—
+9K193506NuVasive X-Core Expandable VBR System, NuVasive X-Core Mini Cervical Expandable VBR SystemNu Vasive, Incorporated20201—
+9K193255Largo PEEK Interbody SystemFlospine, LLC20201—
+9K193521Steerable Plateau TiLife Spine, Inc.20201—
+9K193258ProLift Expandable SystemLife Spine, Inc.20203—
+9K192582NuVasive CoRoent Small Interlock SystemNu Vasive, Incorporated201930—
+9K192168Idys ALIF ZP 3DTiClariance, Sas20195—
+9K191584FORTICO Anterior Cervical Fixation SystemCamber Spine Technologies, LLC20192—
+9K191039Navigated T2 STRATOSPHERE Inserters and Navigated TemplatesMedtronic Sofamor Danek USA, Inc.201918—
+9K183064TxTi IBF SystemInnovasis, Inc.2019481
+9K182608Oyster ACIF CageSilony Medical GmbH20190—
+9K191263Idys ALIF TiVacClariance, Sas20190—
+9K190655SeaSpine® Shoreline™ ACS- Anterior Cervical Standalone SystemSeaSpine Orthopedics Corporation201974—
+9K181625Life Spine Resolute™ Threaded Cage SystemLife Spine, Inc.20180—
+9K181531SpineEX Sagittae Lateral Lumbar Interbody Fusion DevicesSpineex, Inc.20183—
+9K181453ATEC ALIF Spacer SystemAlphatec Spine, Inc.2018111—
+9K181203Juliet TiSpineart20181—
+9K181119Range (Denali and Mesa) Spinal SystemsK2m, Inc.20185—
+9K173189Lumfuse TPPrecifit Medical, Ltd.20180—
+9K180891EVOL Spinal Interbody System, EVOS Lumbar Interbody SystemCutting Edge Spine, LLC20181—
+9K172947HALF DOME Posterior Lumbar Interbody SystemAstura Medical201822—
+9K180376K2M Patient Specific RodsK2m, Inc.20182—
+9K171495Zyston Strut Open Titanium Spacer SystemZimmer Biomet Spine, Inc.20181—
+9K172828Double Medical Cage SystemDouble Medical Technology, Inc.20181—
+9K171434ROCCIA® MultiLIFSilony Medical GmbH20174—
+9K172756Varian cageMedyssey USA, Inc.20171—
+9K173030Vertera Spine Cohere Cervical Interbody Fusion DeviceNu Vasive, Incorporated201722—
+9K173175Paramount Anterior Cervical Cage SystemSpine Wave, Inc.20170—
+9K172199ELEVATE Spinal System, CAPSTONE PTC Spinal System, CRESCENT Spinal System, CRESCENT…Medtronic Sofamor Danek20176—
+9K163422Shanghai Sanyou PEEK Cage SystemShanghai Sanyou Medical Co, Ltd.20173—
+9K171832Range/Denali/Mesa Spinal SystemK2m, Inc.201713—
+9K171749Velofix (tm) Interbody Fusion SystemU&I Corporation20175—
+9K171031CRESCENT™ Spinal SystemMedtronic Sofamor Danek2017144—
+9K170962NuVasive® CoRoent® Thoracolumbar SystemNu Vasive, Incorporated2017304—
+9K170961NuVasive CoRoent Small Interlock II SystemNu Vasive, Incorporated201718—
+9K170395Talos® Lumbar (HA) PEEK IBF DevicesMeditech Spine, LLC201710—
+9K162212Divergence-L Anterior/Oblique Lumbar Fusion SystemMedtronic Sofamor Danek USA, Inc.201757—
+9K163670Rampart One Lumbar Interbody Fusion DeviceSpineology, Inc.20173—
+9K163707NuVasive CoRoent Ti-C SystemNu Vasive, Incorporated201719—
+9K163581Navigated ELEVATE Inserter, Navigated Disc Prep InstrumentsMedtronic Sofamor Danek USA, Inc.2017103—
+9K163543Biomet Fusion SystemZimmer Biomet Spine, Inc.2017124—
+9K162680SOVEREIGN® Spinal SystemMedtronic Sofamor Danek USA, Inc.201631—