510(k) Report

Devices descending from K003155

2,091 later devices reach Vertebral Body Replacement through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K181921Solidity Vertebral Body ReplacementUlrich Medical USA20182—
+1K111294Santorini Spinal SystemK2m, Inc.201218—
+1K070786X-Pod Adjustable Vertebral Body ReplacementTheken Spine, LLC20070—
+1K070181Sintea Biotech DSC/Alf Spinal System, DSC.XX.T5.XX, Alf.XX.T5.XXSintea Biotech, Inc.20071—
+1K050058Theken Reveal VBR SystemTheken Surgical,Llc2005727—
+1K041798Atalia Titanium Surgical MeshUs Spinal Technologies, LLC20050—
+1K012254VBROsteotech, Inc.20012,058—
+2K200235KONG-TL VBR System, KONG-C VBR SystemIcotec AG20201—
+2K192117Small VBR™Ulrich GmbH & Co. KG20196—
+2K183083Shoreline Cervical Interbody RT SystemSeaSpine Orthopedics Corporation201960—
+2K181328T2 STRATOSPHERE™ Expandable Corpectomy SystemMedtronic Sofamor Danek USA, Inc.201828—
+2K180673Normandy VBR SystemZavation Medical Products, LLC20187—
+2K173800Camber Spine Technologies SPIRA - V™ Open Matrix Corpectomy CageCamber Spine Technologies20180—
+2K172926SeaSpine Vu cPOD, Zuma-C, Complete CervicalSeaSpine Orthopedics Corporation201761—
+2K171704CAPRI Corpectomy Cage SystemK2m201710—
+2K162133VerteFIT Corpectomy Cage SystemLdr Spine USA, Inc.20170—
+2K170055CAPRI Corpectomy Cage SystemK2m201711—
+2K151481Sahara Stabilization SystemK2m, Inc.20155—
+2K151538NuVasive PEEK Corpectomy Railed SystemNu Vasive, Incorporated201513—
+2K151167NuVasive PEEK Corpectomy SystemNu Vasive, Incorporated201513—
+2K142205NuVasive X-CORE (R) Expandable VBR SystemNuvasive, Inc.201574—
+2K142016CAPRIK2m, Inc.201412—
+2K140563Lateral VBR SystemNu Vasive, Incorporated20140—
+2K133802Ais Modulift VBR SystemAesculap Implant System, Inc.201448—
+2K112429Giza (R) Vertebral Body ReplacementEden Spine, LLC201221
+2K101886DSC/Alf Spinal SystemSintea Plastek, LLC20110—
+2K110864Biospine VBR SystemAesculap Implant Systems, LLC201149—
+2K090841AddplusUlrich GmbH & Co. KG2009215—
+2K082712Theken Spine VU Epod and VU Lpod SystemTheken Spine, LLC2009118—
+2K080822VU Apod Intervertabral Body Fusion DeviceTheken Spine, LLC20087081
+2K071031VU E*Pod Vertebral Body ReplacementTheken Spine, LLC2007119—
+2K070381Theken VU Mesh VBR SystemTheken Spine, LLC200725—
+2K060416Obelisc Vertebral Body Replacement DeviceUlrich GmbH & Co. KG200656—
+2K053080Graftcage AcxOsteotech, Inc.20050—
+2K021791Verte-Stack Spinal SystemMedtronic Sofamor Danek20022,047—
+3K261031Poseidon STSignus Medinzintechnik GmbH20260—
+3K253420Admiral ACP System; Explorer TO System; Laminoplasty System; Manta Ray TDF Spacer…SeaSpine Orthopedics Corporation20260—
+3K232790KONG®-TL VBR System and KONG® C VBR SystemIcotec AG20240—
+3K232173Ascend VBR System, Ascend NanoTec VBR SystemAlphatec Spine, Inc.20230—
+3K220296Manta Ray TDF SpacerSeaSpine Orthopedics Corporation20231—
+3K221719ABTross ALIF Expandable Cage SystemAegis Spine, Inc.20222—
+3K211892ArtFx Corpectomy Cages (Espinax and Distractania Corpectomy Cages)Arftx Medical, LLC20222—
+3K213359SeaSpine WaveForm, C Interbody SystemSeaSpine Orthopedics Corporation20217—
+3K210497SeaSpine Spacer System NM (Hollywood, Hollywood VI, Pacifica, Redondo, Ventura), Vu…SeaSpine Orthopedics Corporation202139—
+3K201193SeaSpine Spacer System NM (Hollywood, Hollywood VI, Pacifica, Redondo, Ventura), Vu…SeaSpine Orthopedics Corporation202018—
+3K201073Seaspine WaveForm C Interbody SystemSeaSpine Orthopedics Corporation202017—
+3K201646Shoreline ACS (Anterior Cervical System)SeaSpine Orthopedics Corporation202020—
+3K201585Monterey AL Interbody SystemStryker Corporation202044
+3K193506NuVasive X-Core Expandable VBR System, NuVasive X-Core Mini Cervical Expandable VBR SystemNu Vasive, Incorporated20201—
+3K192502Anatomic PEEK™ Cervical Fusion System, Anatomic PEEK™ PTC Cervical Fusion System…Medtronic Sofamor Danek USA, Inc.20204—
+3K190349MediExpand TL Expandable VBR SystemCmf Medicon Surgical, Inc.20190—
+3K192214CarboClear VBR SystemCarboFix Orthopedics, Ltd.20191—
+3K191423Normandy VBR SystemZavation Medical Products, LLC20193—
+3K183510T2 STRATOSPHERE Expandable Corpectomy SystemMedtronic Sofamor Danek USA, Inc.201927—
+3K183071VLIFT-s Vertebral Body Replacement SystemStryker Spine20194—
+3K180665SANTORINI Corpectomy Cage System, CAPRI Corpectomy Cage SystemK2m, LLC20189—
+3K173606SeaSpine Vu a•POD Prime NanoMetalene Intervertebral Body Fusion Device, SeaSpine Vu…SeaSpine Orthopedics Corporation201859—
+3K173260SeaSpine Spacer System (NanoMetalene)- Hollywood, Hollywood VI, Ventura, Pacifica…SeaSpine Orthopedics Corporation201767—
+3K172032Modulift Vertebral Body Replacement (VBR) SystemAesculap Implants Systems, Inc.201746—
+3K172323Omnia Medical VBROmnia Medical, LLC20176—
+3K170271NuVasive (r) Monolith Corpectomy SystemNu Vasive, Incorporated201712—
+3K151651NuVasive X-CORE Mini Cervical Expandable VBR SystemNu Vasive, Incorporated201568—
+3K142488SeaSpine Spacer System - (Hollywood, Pacifica, Redondo, Ventura) NanoMetalene, Cambria…Seaspine, Inc.2014116—
+3K142150Ais Modulift VBR SystemAesculap Implant System, Inc.201447—
+3K123969XiphosDifusion Technologies201314—
+3K121107Fortify Integrated Corpectomy Spacers, (Fortify I and Fortify I-R)Globus Medical, Inc.2012214—
+3K112986Lateral Fusion DeviceIntegra Spine (Integra Lifesciences)2012126—
+3K112493Pass LP Spinal SystemMedicrea International20111—
+3K112359Prow FusionNlt Spine, Ltd.2011601—
+3K111965Vusion (R) OSOrtho Development20110—
+3K101310VU Apod Intervertebral Body Fusion DeviceTheken Spine, LLC2010480—
+3K100544Impix Lumbar Interbody DeviceMedicrea Technologies201001
+3K081383Reliance VBS SystemReliance Medical Systems, LLC20080—
+3K072537Creaspine Supstance Vertebral Body Replacement SystemCreaspine Sas20071—
+3K063637Reliance VBS SystemReliance Medical Systems, LLC20071—
+3K052261Modification to: Verte-Stack Spinal SystemMedtronic Sofamor Danek USA, Inc.2005839—
+3K050809CD Horizon Spinal SystemMedtronic Sofamor Danek USA, Inc.2005870—
+3K042201Novel VBR Spinal SystemAlphatec/Nexmed2004796—
+3K041452Modification to Verte-Stack Spinal SystemMedtronic Sofamor Danek2004815—
+3K033109Ellys and Aurys Vertebral Body ReplacementsScient'X20041,218—
+3K031780Verte-Stack Spinal SystemMedtronic Sofamor Danek20031,326—
+3K030735Modified Verte-Stack Spinal SystemMedtronic Sofamor Danek2003816—
+3K030736Verte-Stack Spinal System, Extra Small SizesMedtronic Sofamor Danek20031,101—
+3K030601Verte-Stack Spinal SystemMedtronic Sofamor Danek20031,151—
+3K023570Modification to Verte-Stack Spinal SystemMedtronic Sofamor Danek20021,383—
+4K254105Hive™ Standalone Cervical System and Hive™ C Interbody SystemNanoHive Medical, LLC20260—
+4K250773Luna® Ti Interbody Fusion SystemSpinal Elements, Inc.20260—
+4K252686EffortMed PEEK Cages & Corpectomy CagesEffortmed, LLC20251—
+4K250076Endeavor™ Stand-Alone Cervical IBF SystemInnovasis20250—
+4K250072CONDUIT™ SYNFIX™ Evolution Secured Spacer SystemAvalign Technologies, Inc.20251—
+4K251431FIX-C PEEK ACIF SA SystemJeil Medical Corporation20250—
+4K243188Cylox® STSignus Medizintechnik GmbH20250—
+4K241468Vertiwedge® Intraosseous SystemFoundation Surgical Group, Inc.20241—
+4K241164IB3D™ PL Spinal SystemMedicrea International S.A.S. (Medtronic)202412
+4K240830Reef TO/TA System; Regatta Lateral System; Explorer TO System; WaveForm C Interbody…Orthofix Medical, Inc.20242—
+4K241466Shoreline ACS Interbody System; Shoreline RT Interbody System; Regatta Lateral System…SeaSpine Orthopedics Corporation20243—
+4K240566Reef L Interbody System; WaveForm L Interbody SystemSeaSpine Orthopedics Corporation20245—
+4K233414Shoreline ACS Interbody System; Shoreline RT Interbody SystemSeaSpine Orthopedics Corporation20238—
+4K222874CarboClear Cervical Cage System, CarboClear Cervical VBR SystemCarbofix Orthpedics, Ltd.20230—
+4K230936Anatomic PEEK™ Cervical Fusion System with NanotechnologyNanovis, LLC20230—