510(k) Report

Devices descending from K040731

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

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+10K253216IntraOp Alignment System; CONTOUR3D Bending SystemAlphatec Spine, Inc.20260—
+10K261665CORUS™ Navigation System-GNProvidence Medical Technology, Inc.20260—
+10K260989Varion Thoracolumbar Fixation SystemKyocera Medical Technologies Inc. (KMTI)20260—
+10K252542LEO Spinal SystemZheJiang Decans Medical Devices Co., Ltd.20260—
+10K260216CD Horizon™ ModuLeX™ Fenestrated Screw Set; CD Horizon™ ModuLeX™ Spinal SystemMedtronic Sofamor Danek USA, Inc.20260—
+10K260011Foundation Surgical Navigated Lateral Disc Prep InstrumentsFoundation Surgical Group, Inc.20260—
+10K253748Life Spine ProLift & ProLift Lateral and ProLift Lateral Fixated Expandable Spacer SystemLife Spine, Inc.20260—
+10K251302OptiMesh Multiplanar Expandable Interbody Fusion SystemSpineology, Inc.20250—
+10K251829DeGen Medical Patient Specific Implant (PSI) SystemDegen Medical20250—
+10K252610ZSFab Lumbar Interbody SystemZsfab, Inc.20251—
+10K252742Navigated InstrumentsTyber Medical, LLC20251—
+10K253335CD Horizon™ Spinal SystemMedtronic Sofamor Danek USA, Inc.20250—
+10K253331PressON Spinal Fixation SystemNexus Spine20250—
+10K251060CORUS™ Navigation System-GXProvidence Medical Technology, Inc.20250—
+10K241525ExcelsiusXR™Globus Medical, Inc.20250—
+10K243474MagnetOs MISKuros Biosciences B.V20250—
+10K243946EffortMed Spinal Fixation SystemEffortmed, LLC20251—
+10K243814NuVasive Pulse SystemGlobus Medical, Inc.20250—
+10K242797OsteoFlo HydroFiberSurGenTec, LLC20241—
+10K241564Actifuse ABX; Actifuse MIS; Actifuse Shape; ALTAPORE; ALTAPORE SHAPE; ALTAPORE MISBaxter Healthcare Corporation20240—
+10K241321Juliet® Ti LL Lumbar Interbody DeviceSpineart SA20240—
+10K241212MagnetOs Easypack PuttyKuros Biosciences20241—
+10K233228Spine Navigation and Robotic-Assistance DeviceEcential Robotics202421
+10K241082INNOVERSE Navigation InstrumentsInnosys Co., Ltd.20240—
+10K240951Invictus Robotic Navigation InstrumentsAlphatec Spine20242—
+10K240568DuraPro™ Oscillating SystemGlobus Medical, Inc.20240—
+10K233951CD Horizon ModuLeX Spinal System (Shanks, Head Assemblies, and Set Screw)Medtronic Sofamor Danek USA, Inc.20245—
+10K240424Mineral Collagen Composite Bioactive Moldable Bone Graft MatrixCollagen Matrix, Inc.20240—
+10K240453ReBOSSISOrthorebirth Co., Ltd.202402
+10K233638VERZA™ High Speed DrillsGlobus Medical, Inc.20241—
+10K234013Mg OSTEOINJECT™; Mg OSTEOREVIVE™; Mg OSTEOCRETE™Bone Solutions, Inc.20243—
+10K233508iFuse Bedrock Granite® Implant SystemSI-BONE, Inc.20245—
+10K232014CONDUIT™ ATP InsertersEnztec Limited20230—
+10K231735NuVasive CoRoent Small Interbody System; NuVasive CoRoent Small Contoured Interbody…Nu Vasive, Incorporated20239—
+10K222383Anteralign™ LS Spinal System with Titan nanoLOCK™ Surface Technology MAZORX Stealth (TM)…Medtronic Sofamor Danek USA, Inc.20220—
+10K212653Catalyft LS Expandable Interbody SystemMedtronic Sofamor Danek USA, Inc.202127
+10K211740DualXAmplify Surgical, Inc.20211—
+10K211449Triton™ Sacroiliac Joint Fixation SystemChoice Spine, LLC20211—
+10K211616ExcelsiusHubGlobus Medical, Inc.20219Class I
+10K200047ExcelsiusGPS Cranial 1.0 ModuleGlobus Medical, Inc.202053
+10K200879SeaSpine Meridian System, SeaSpine Regatta Lateral SystemSeaSpine Orthopedics Corporation202060—
+10K200991EVOL Spinal Interbody SystemCutting Edge Spine, LLC20200—
+10K192434DualX Lumbar Intervertebral Body Fusion DeviceAmplify Surgical, Inc.20190—
+10K192047Rampart™ One Lumbar Interbody Fusion SystemSpineology, Inc.20190—
+10K190959ARTiC-L 3D Ti Spinal System with TiONIC Technology, ARTiC-XL 3D Ti Spinal System with…Medtronic Sofamor Danek USA, Inc.2019108—
+10K183397ChoiceSpine Stealth Cervical Spacer SystemChoicespine, LP201916—
+10K181921Solidity Vertebral Body ReplacementUlrich Medical USA20182—
+10K181079SeaSpine Regatta Lateral SystemSeaSpine Orthopedics Corporation201863—
+10K180519HARRIER-SA™ Lumbar Interbody SystemChoicespine, LP20180—
+10K173606SeaSpine Vu a•POD Prime NanoMetalene Intervertebral Body Fusion Device, SeaSpine Vu…SeaSpine Orthopedics Corporation201859—
+10K173260SeaSpine Spacer System (NanoMetalene)- Hollywood, Hollywood VI, Ventura, Pacifica…SeaSpine Orthopedics Corporation201767—
+10K172343Fortilink® Interbody Fusion (IBF) System with TETRAfuse® 3D TechnologyRti Surgical, Inc.201710—
+10K171425Concorde LiftMedos International SARL201782
+11K261113Op.n™ Spine Navigation and Robotic GuidanceEcential Robotics20261—
+11K261060Navigated LLIF Impactable TrackerTyber Medical, LLC20260—
+11K260549ZSFab Cervical Interbody System and ZSFab Lumbar Interbody SystemZsfab, Inc.20260—
+11K254274ARx® SAI Implant SystemLife Spine, Inc.20260—
+11K254247Osteomni Spinal Fixation SystemOsteomni, Inc.20260—
+11K252322SIros-X SystemGenesys Spine20250—
+11K251522Mg OSTEOINJECT™; Mg OSTEOREVIVE™; Mg OSTEOCRETE™Bone Solutions, Inc.20251—
+11K253094iFuse Bedrock Granite Implant SystemSI-BONE, Inc.20250—
+11K243949OsteoFlo HydroFiberSurGenTec, LLC20250—
+11K243671ExcelsiusGPS® InstrumentsGlobus Medical, Inc.20240—
+11K241992Catalyft™ LS Expandable Interbody SystemMedtronic Sofamor Danek USA, Inc.20240—
+11K243007CD Horizon™ Spinal SystemMedtronic Sofamor Danek USA, Inc.20243—
+11K242372Mg OSTEOREVIVE™, Mg OSTEOCRETE™Bone Solutions, Inc.20242—
+11K233807LumiVy™ Lumbar IBF SystemVy Spine, LLC20241—
+11K241464ARx® SAI Implant SystemLife Spine, Inc.20241—
+11K240721ExcelsiusFlex™Globus Medical, Inc.20240—
+11K231850QUARTEX® Occipito-Cervico-Thoracic Spinal System ExcelsiusGPS® InstrumentsGlobus Medical, Inc.20242—
+11K223412LumiVy™ Lumbar IBF SystemVy Spine, LLC20235—
+11K211785CASSATT™ SIJ Fixation SystemCtl Medical Corporation20220—
+11K221858ZSFab Lumbar Interbody SystemZsfab, Inc.20224—
+11K213493Fortilink with TiPlus TechnologyParadigm Spine20220—
+11K203153CREO Stabilization System, Navigation Instruments, ExcelsiusGPSGlobus Medical, Inc.20211—
+11K201643ChoiceSpine Tiger Shark Cervical Spacer SystemChoice Spine, LLC20204—
+11K201755WaveForm L Interbody System, WaveForm TO Interbody System, WaveForm TA Interbody SystemSeaSpine Orthopedics Corporation202017—
+11K193418SeaSpine Skipjack SystemSeaSpine Orthopedics Corporation20204—
+11K192132SeaSpine Beachside SystemSeaSpine Orthopedics Corporation2019591
+11K190498Fortilink® IBF System with TETRAfuse®3D Technology, include the following designs…Pioneer Surgical Technology, Inc., Dba Rti Surgical, Inc.20197—
+11K190889Republic Spine Restore Cervical Interbody Fusion SystemRepublic Spine, LLC20190—
+11K182349Concorde LiftMedos International SARL20190—
+11K173537Concorde Lift™Medos International SARL20181—
+12K261205SPINEART Navigation Instrument SystemSpineart SA20260—
+12K253802KHEIRON® Spinal Fixation System, including patient specific K-RODS.M.A.I.O20261—
+12K253739SCRIPT™ Rods, CREO™ Stabilization System, REVERE® Stabilization System, REVERE® 4.5…Globus Medical, Inc.20260—
+12K252327CMORE® CT System; CMORE® CT System Navigated InstrumentsIcotec AG20251—
+12K242734ZSFab Cervical Interbody System; ZSFab Lumbar Interbody SystemZsfab20243—
+12K230414ClariVy™ Cervical IBF SystemVy Spine, LLC20233—
+12K212540Explorer TO SystemSeaSpine Orthopedics Corporation20213—
+12K193636SeaSpine Reef TH SystemSeaSpine Orthopedics Corporation202056—
+12K192718Fortilink Interbody Fusion Device (IBF) with TETRAfuse 3D TechnologyPioneer Surgical Technology, Inc., Dba Rti Surgical, Inc.20195—
+13K262828KHEIRON® Spinal Fixation System, including patient specific K-RODS.M.A.I.O20260—
+13K254045CarboClear® Posterior Cervical Screw System; CarboClear® Hybrid Posterior Cervical Screw…CarboFix Orthopedics, Ltd.20260—
+13K231836ClariVy™ Cervical IBF SystemVy Spine, LLC20232—