510(k) Report

Devices descending from K162315

55 later devices reach FORTIFY Corpectomy Spacers through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K190147COLOSSEUM MeshGlobus Medical, Inc.20190—
+1K183588Choice Spine Hawkeye Vertebral Body Replacement (VBR) SystemChoicespine20195—
+1K183071VLIFT-s Vertebral Body Replacement SystemStryker Spine20194—
+1K180665SANTORINI Corpectomy Cage System, CAPRI Corpectomy Cage SystemK2m, LLC20189—
+1K181328T2 STRATOSPHERE™ Expandable Corpectomy SystemMedtronic Sofamor Danek USA, Inc.201828—
+1K173982FORTIFY Corpectomy SpacersGlobus Medical, Inc.20188—
+1K180673Normandy VBR SystemZavation Medical Products, LLC20187—
+2K241468Vertiwedge® Intraosseous SystemFoundation Surgical Group, Inc.20241—
+2K222874CarboClear Cervical Cage System, CarboClear Cervical VBR SystemCarbofix Orthpedics, Ltd.20230—
+2K221490Tritanium C Anterior Cervical Cage, Tritanium PL Cage, Tritanium TL Curved Posterior…Stryker Spine20231—
+2K211320CAPRI Corpectomy Cage SystemK2m, Inc.20222—
+2K202637F3D Corpectomy SystemCorelink, LLC20201—
+2K200235KONG-TL VBR System, KONG-C VBR SystemIcotec AG20201—
+2K192145Galileo Vertebral Body Replacement DeviceBright Spine20201—
+2K193412NEXXT MATRIXX SystemNexxt Spine, LLC20201—
+2K192502Anatomic PEEK™ Cervical Fusion System, Anatomic PEEK™ PTC Cervical Fusion System…Medtronic Sofamor Danek USA, Inc.20204—
+2K192117Small VBR™Ulrich GmbH & Co. KG20196—
+2K191423Normandy VBR SystemZavation Medical Products, LLC20193—
+2K183510T2 STRATOSPHERE Expandable Corpectomy SystemMedtronic Sofamor Danek USA, Inc.201927—
+3K261810Vertiwedge® Intraosseous SystemFoundation Surgical Group20260—
+3K262061Tritanium® C Anterior Cervical Cage; Tritanium® PL Cage; Tritanium® TL Curved Posterior…Stryker Spine20260—
+3K251431FIX-C PEEK ACIF SA SystemJeil Medical Corporation20250—
+3K241164IB3D™ PL Spinal SystemMedicrea International S.A.S. (Medtronic)202412
+3K232790KONG®-TL VBR System and KONG® C VBR SystemIcotec AG20240—
+3K232481RIGEL™ 3DR Anterior Cervical Corpectomy SystemMiRus, LLC20230—
+3K232173Ascend VBR System, Ascend NanoTec VBR SystemAlphatec Spine, Inc.20230—
+3K230329F3D Interbody SystemCorelink, LLC20230—
+3K230936Anatomic PEEK™ Cervical Fusion System with NanotechnologyNanovis, LLC20230—
+3K221542Galileo Vertebral Body Replacement DeviceBright Spine20230—
+3K211892ArtFx Corpectomy Cages (Espinax and Distractania Corpectomy Cages)Arftx Medical, LLC20222—
+3K191066CD Horizon™ Astute™ Spinal SystemMedtronic Sofamor Danek USA, Inc.201921—
+4K253577IB3D™ PL Spinal System (A24000000 / IB3D Universal Implant Inserter)Medicrea International S.A.S. (Medtronic)20250—
+4K252686EffortMed PEEK Cages & Corpectomy CagesEffortmed, LLC20251—
+4K221646CD HORIZON™ ASTUTE™ SPINAL SYSTEM; CD HORIZON™ Growth Rod Conversion Set; CD HORIZON™…Medtronic Sofamor Danek USA, Inc.202220—
+5K260850Osteomni Spinal Cages SystemOsteomni, Inc.20260—
+5K242350Spinal Alignment Solutions Pelvic Incidence (PI) Rod SystemSpinal Alignment Solutions, Inc.20241—
+5K223494CD Horizon Spinal SystemMedtronic202317—
+6K263172SAS MIS Pelvic Incidence RodsSpinal Alignment Solutions, Inc.20260—
+6K260989Varion Thoracolumbar Fixation SystemKyocera Medical Technologies Inc. (KMTI)20260—
+6K252542LEO Spinal SystemZheJiang Decans Medical Devices Co., Ltd.20260—
+6K260216CD Horizon™ ModuLeX™ Fenestrated Screw Set; CD Horizon™ ModuLeX™ Spinal SystemMedtronic Sofamor Danek USA, Inc.20260—
+6K260011Foundation Surgical Navigated Lateral Disc Prep InstrumentsFoundation Surgical Group, Inc.20260—
+6K253335CD Horizon™ Spinal SystemMedtronic Sofamor Danek USA, Inc.20250—
+6K253331PressON Spinal Fixation SystemNexus Spine20250—
+6K241082INNOVERSE Navigation InstrumentsInnosys Co., Ltd.20240—
+6K233951CD Horizon ModuLeX Spinal System (Shanks, Head Assemblies, and Set Screw)Medtronic Sofamor Danek USA, Inc.20245—
+6K233508iFuse Bedrock Granite® Implant SystemSI-BONE, Inc.20245—
+7K262067iFuse Granite Onyx™ Implant SystemSI-BONE, Inc.20260—
+7K254274ARx® SAI Implant SystemLife Spine, Inc.20260—
+7K252322SIros-X SystemGenesys Spine20250—
+7K253094iFuse Bedrock Granite Implant SystemSI-BONE, Inc.20250—
+7K243007CD Horizon™ Spinal SystemMedtronic Sofamor Danek USA, Inc.20243—
+7K241464ARx® SAI Implant SystemLife Spine, Inc.20241—
+8K253802KHEIRON® Spinal Fixation System, including patient specific K-RODS.M.A.I.O20261—
+9K262828KHEIRON® Spinal Fixation System, including patient specific K-RODS.M.A.I.O20260—