510(k) Report

Devices descending from K131724

73 later devices reach Pioneer Maxfuse Vertebral Body Replacement Device through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K142005SpineFab Vertebral Body Replacement (VBR) SystemOxford Performance Materials201513—
+1K142030STGC-LordoticCardinal Spine, LLC201558—
+2K253158VyBrate™ VBR SystemVy Spine, LLC20260—
+2K163673Fortilink™-C with TETRAfuse™ 3D TechnologyRti Surgical, Inc.201711—
+2K152568C-VBRCardinal Spine, LLC201657—
+3K231836ClariVy™ Cervical IBF SystemVy Spine, LLC20232—
+3K232481RIGEL™ 3DR Anterior Cervical Corpectomy SystemMiRus, LLC20230—
+3K230026SqualeImplanet, S.A.20230—
+3K213493Fortilink with TiPlus TechnologyParadigm Spine20220—
+3K192718Fortilink Interbody Fusion Device (IBF) with TETRAfuse 3D TechnologyPioneer Surgical Technology, Inc., Dba Rti Surgical, Inc.20195—
+3K183071VLIFT-s Vertebral Body Replacement SystemStryker Spine20194—
+3K173893TrabisColigne AG20180—
+3K162315FORTIFY Corpectomy SpacersGlobus Medical, Inc.201755—
+4K241468Vertiwedge® Intraosseous SystemFoundation Surgical Group, Inc.20241—
+4K233807LumiVy™ Lumbar IBF SystemVy Spine, LLC20241—
+4K221490Tritanium C Anterior Cervical Cage, Tritanium PL Cage, Tritanium TL Curved Posterior…Stryker Spine20231—
+4K201453Fortilink Cages with TiPlus TechnologyParadigm Spine GmbH20204—
+4K190147COLOSSEUM MeshGlobus Medical, Inc.20190—
+4K183588Choice Spine Hawkeye Vertebral Body Replacement (VBR) SystemChoicespine20195—
+4K180665SANTORINI Corpectomy Cage System, CAPRI Corpectomy Cage SystemK2m, LLC20189—
+4K181328T2 STRATOSPHERE™ Expandable Corpectomy SystemMedtronic Sofamor Danek USA, Inc.201828—
+4K173982FORTIFY Corpectomy SpacersGlobus Medical, Inc.20188—
+4K180673Normandy VBR SystemZavation Medical Products, LLC20187—
+5K261810Vertiwedge® Intraosseous SystemFoundation Surgical Group20260—
+5K262061Tritanium® C Anterior Cervical Cage; Tritanium® PL Cage; Tritanium® TL Curved Posterior…Stryker Spine20260—
+5K241783FortiVy™ OsteoVy™ Lumbar IBFVy Spine, LLC20250—
+5K242260aprevo® Cervical ACDF; aprevo® Cervical ACDF-X; aprevo® Cervical ACDF-X NO CAMCarlsmed, Inc.20243—
+5K222874CarboClear Cervical Cage System, CarboClear Cervical VBR SystemCarbofix Orthpedics, Ltd.20230—
+5K211320CAPRI Corpectomy Cage SystemK2m, Inc.20222—
+5K202637F3D Corpectomy SystemCorelink, LLC20201—
+5K200235KONG-TL VBR System, KONG-C VBR SystemIcotec AG20201—
+5K192145Galileo Vertebral Body Replacement DeviceBright Spine20201—
+5K193412NEXXT MATRIXX SystemNexxt Spine, LLC20201—
+5K192502Anatomic PEEK™ Cervical Fusion System, Anatomic PEEK™ PTC Cervical Fusion System…Medtronic Sofamor Danek USA, Inc.20204—
+5K192117Small VBR™Ulrich GmbH & Co. KG20196—
+5K191423Normandy VBR SystemZavation Medical Products, LLC20193—
+5K183510T2 STRATOSPHERE Expandable Corpectomy SystemMedtronic Sofamor Danek USA, Inc.201927—
+6K250827aprevo® anterior lumbar interbody fusion device; aprevo® lateral lumbar interbody fusion…Carlsmed, Inc.20252—
+6K251431FIX-C PEEK ACIF SA SystemJeil Medical Corporation20250—
+6K241164IB3D™ PL Spinal SystemMedicrea International S.A.S. (Medtronic)202412
+6K232790KONG®-TL VBR System and KONG® C VBR SystemIcotec AG20240—
+6K232173Ascend VBR System, Ascend NanoTec VBR SystemAlphatec Spine, Inc.20230—
+6K230329F3D Interbody SystemCorelink, LLC20230—
+6K230936Anatomic PEEK™ Cervical Fusion System with NanotechnologyNanovis, LLC20230—
+6K221542Galileo Vertebral Body Replacement DeviceBright Spine20230—
+6K211892ArtFx Corpectomy Cages (Espinax and Distractania Corpectomy Cages)Arftx Medical, LLC20222—
+6K191066CD Horizon™ Astute™ Spinal SystemMedtronic Sofamor Danek USA, Inc.201921—
+7K260385aprevo® anterior and lateral lumbar interbody system; aprevo® posterior and…Carlsmed, Inc.20260—
+7K252894aprevo® cervical interbody systemCarlsmed, Inc.20261—
+7K253577IB3D™ PL Spinal System (A24000000 / IB3D Universal Implant Inserter)Medicrea International S.A.S. (Medtronic)20250—
+7K252686EffortMed PEEK Cages & Corpectomy CagesEffortmed, LLC20251—
+7K221646CD HORIZON™ ASTUTE™ SPINAL SYSTEM; CD HORIZON™ Growth Rod Conversion Set; CD HORIZON™…Medtronic Sofamor Danek USA, Inc.202220—
+8K260850Osteomni Spinal Cages SystemOsteomni, Inc.20260—
+8K242350Spinal Alignment Solutions Pelvic Incidence (PI) Rod SystemSpinal Alignment Solutions, Inc.20241—
+8K223494CD Horizon Spinal SystemMedtronic202317—
+9K263172SAS MIS Pelvic Incidence RodsSpinal Alignment Solutions, Inc.20260—
+9K260989Varion Thoracolumbar Fixation SystemKyocera Medical Technologies Inc. (KMTI)20260—
+9K252542LEO Spinal SystemZheJiang Decans Medical Devices Co., Ltd.20260—
+9K260216CD Horizon™ ModuLeX™ Fenestrated Screw Set; CD Horizon™ ModuLeX™ Spinal SystemMedtronic Sofamor Danek USA, Inc.20260—
+9K260011Foundation Surgical Navigated Lateral Disc Prep InstrumentsFoundation Surgical Group, Inc.20260—
+9K253335CD Horizon™ Spinal SystemMedtronic Sofamor Danek USA, Inc.20250—
+9K253331PressON Spinal Fixation SystemNexus Spine20250—
+9K241082INNOVERSE Navigation InstrumentsInnosys Co., Ltd.20240—
+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—
+10K262067iFuse Granite Onyx™ Implant SystemSI-BONE, Inc.20260—
+10K254274ARx® SAI Implant SystemLife Spine, Inc.20260—
+10K252322SIros-X SystemGenesys Spine20250—
+10K253094iFuse Bedrock Granite Implant SystemSI-BONE, Inc.20250—
+10K243007CD Horizon™ Spinal SystemMedtronic Sofamor Danek USA, Inc.20243—
+10K241464ARx® SAI Implant SystemLife Spine, Inc.20241—
+11K253802KHEIRON® Spinal Fixation System, including patient specific K-RODS.M.A.I.O20261—
+12K262828KHEIRON® Spinal Fixation System, including patient specific K-RODS.M.A.I.O20260—