510(k) Report

Devices descending from K043206

1,571 later devices reach Pioneer Vertebral Body Replacement Device (Pioneer Vertebral Spacer) through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+5K134038Camber Spine Diagon Oblique CageCamber Spine201428—
+5K133893Sterispine LC CageSafe Orthopaedics20141—
+5K132926Velofixtm Interbody Fusion SystemU&I Corp.201410—
+5K133557Juliet LL Lateral Lumbar CageSpineart2014147—
+5K133192Mectalif TipeekMedacta International201416—
+5K133286Midline (TM)Centinel Spine, Inc.2014460—
+5K133216Crescent Spinal SystemMedtronic Sofamor Danek, Inc.201392—
+5K131178Idys Lif CagesClariance201311—
+5K132700Perimeter Interbody Fusion DeviceMedtronic Sofamor Danek, Inc.2013170—
+5K130641Logic Stand-Alone Intervertebral Body Fusion DeviceBinder Biomedical, Inc.20130—
+5K130461Stalif XCentinel Spine, Inc.201313—
+5K131951Irix-C Cervical Integrated Fusion SystemX-Spine Systems, Inc.201312—
+5K123027Capstone (R) Spinal SystemMedtronic Sofamor Danek, Inc.2013709—
+5K122957Tezo Titanium Cage FamilyUlrich GmbH & Co. KG20130—
+5K124034Mectalif AnteriorMedacta International201311—
+5K123045Brigade Standalone SystemNuvasive, Inc.2013696—
+5K112700Frontier Sadl Interbody Fusion DeviceFrontier Medical Devices, Inc.20121—
+5K120869Anchor-L Lumbar CageStryker Spine2012638—
+5K122989Biomet Lateral Spacer SystemBiomet Spine (Aka Ebi, LLC)2012171—
+5K1217414-Web Cervical STS (Spinal Truss System)4-Web, Inc.201235—
+5K122085Stingray Cervical CageOmni Surgical, LP Dba Spine36020120—
+5K121567Oracle Lumbar Intervertebral Body Fusion Cage SystemAccel Spine20125—
+5K122591Clydesdale Spinal SystemMedtronic Sofamor Danek, Inc.201214—
+5K121892Phantom Plus Ceramic Cage SystemAmedica Corp.20127—
+5K120991TRANS1 Interbody Fusion SystemTrans1 Incorporated2012172—
+5K121982Sovereign Spinal SystemMedtronic Sofamor Danek2012155—
+5K121096Venus Lumbar Intervertebral Body Fusion Cage SystemL&K BIOMED Co., Ltd.201236—
+5K121683Acculif TL CageCoalign Innovations, Inc.2012682—
+5K120063Venus Lumbar Intervertebral Body Fusion Cage SystemL&K BIOMED Co., Ltd.201237—
+5K120031Chesapeake Spinal SystemK2m, Inc.2012334—
+5K112561Nuvasive Coroent NO-Profile SystemNuvasive, Inc.201212—
+5K113642Perimeter Interbody Fusion DeviceMedtronic Sofamor Danek USA2012292—
+5K112405Clydesdales Spinal SystemMedtronic Sofamor Danek USA, Inc.2011296—
+5K110063Sovereign Spinal SystemMedtronic Sofamor Danek, Inc.2011718—
+5K111626Endoskeleton (R) TasTitan Spine, LLC2011273—
+5K111525Perimeter Interbody Fusion DeviceMedtronic Sofamor Danek2011355—
+5K103655Octane-C Interbody Fusion Device SystemExactech, Inc.2011481
+5K103369Vault Alif SystemSpinal USA201110—
+5K093093Small Plateau Spacer SystemLife Spine2010393—
+5K101301Stalif MidlineCentinel Spine2010474—
+5K100889Endoskeleton TCTitan Spine, LLC2010455—
+5K100802Aesculap Implant Systems Sibd Spinal SystemAesculap Implant Systems, Inc.2010461—
+5K100043Coroent XLR Standalone SystemNuvasive, Inc.2010744—
+5K092211Chesapeake Spinal SystemK2m, Inc.2010450—
+5K091301Life Spine Stand-Alone Spacer SystemLife Spine2009473—
+5K083475Lucent MagnumSpinal Elements, Inc.2009834—
+5K081711Lucent Magnum+Spinal Elements, Inc.20080—
+6K262726NeckTune™ SA Cervical CageMedyssey Co., Ltd.20260—
+6K261451ZSAlign Cervical Interbody SystemZSFab, Inc.20260—
+6K261810Vertiwedge® Intraosseous SystemFoundation Surgical Group20260—
+6K261809Interwedge® Standalone LateralFoundation Surgical Group20260—
+6K261113Op.n™ Spine Navigation and Robotic GuidanceEcential Robotics20261—
+6K261279DeltaNEC Interbody SystemNexus Spine20260—
+6K253151Fule Interbody Fusion Cage SystemBeijing Fule Science & Technology Development Co., Ltd.20260—
+6K261159Exceed® Biplanar Expandable Interbody SystemSpine Wave, Inc.20260—
+6K260329Ion-C Navigation InstrumentsSurGenTec, LLC20261—
+6K260989Varion Thoracolumbar Fixation SystemKyocera Medical Technologies Inc. (KMTI)20260—
+6K254202MectaLIF 3D Metal AnteriorMedacta International S.A.20260—
+6K252542LEO Spinal SystemZheJiang Decans Medical Devices Co., Ltd.20260—
+6K260660SABER-C SystemElevation Spine20261—
+6K260549ZSFab Cervical Interbody System and ZSFab Lumbar Interbody SystemZsfab, Inc.20260—
+6K260216CD Horizon™ ModuLeX™ Fenestrated Screw Set; CD Horizon™ ModuLeX™ Spinal SystemMedtronic Sofamor Danek USA, Inc.20260—
+6K260340HC Biologics Osteopoint Peek Cages, HC Biologics Osteopoint Cervical Peek Cages, HC…HC Biologics, LLC20260—
+6K254017SWINGO-3D Lumbar Cage SystemImplanet20260—
+6K253559Ventana™ A Anterior Lumbar Interbody SystemSpinal Elements, Inc.20260—
+6K253583LUX Expandable Lumbar Interbody SystemXenix Medical20260—
+6K252597Valence Robotic Navigation System; Valence Robotic Navigation Instruments (For Use with…Alphatec Spine, Inc.20261—
+6K250773Luna® Ti Interbody Fusion SystemSpinal Elements, Inc.20260—
+6K252205Curiteva Porous PEEK Cervical Interbody System; Curiteva Porous PEEK Lumbar Interbody…Curiteva, Inc.20260—
+6K254061Curiteva Porous PEEK Cervical Interbody Fusion SystemCuriteva, Inc.20260—
+6K253266Titanium Interbody SystemSpine Innovation, LLC20260—
+6K253577IB3D™ PL Spinal System (A24000000 / IB3D Universal Implant Inserter)Medicrea International S.A.S. (Medtronic)20250—
+6K253200Cervical Spine Truss System - Stand Alone (CSTS-SA)4Web Medical, Inc.20250—
+6K250560BEE HANGMedical GmbH20250—
+6K252686EffortMed PEEK Cages & Corpectomy CagesEffortmed, LLC20251—
+6K252351UniSpace® TPLIF CageCg Medtech Co., Ltd.20250—
+6K252742Navigated InstrumentsTyber Medical, LLC20251—
+6K253335CD Horizon™ Spinal SystemMedtronic Sofamor Danek USA, Inc.20250—
+6K253331PressON Spinal Fixation SystemNexus Spine20250—
+6K252737DeGen Medical Latitude-C AM Cervical Interbody Fusion SystemDegen Medical20250—
+6K250076Endeavor™ Stand-Alone Cervical IBF SystemInnovasis20250—
+6K251479Mobarn 80:20 Lumbar Interbody Fusion System (Posterior Lumbar Interbody Fusion Cage…Mobarn Medical Devices, LLC20250—
+6K251444Endoskeleton™ Interbody SystemsMedtronic Sofamor Danek USA, Inc.20250—
+6K250335IVA & AEON Cervical and Lumbar Cage SystemK&J Consulting20250—
+6K250540SABER-C SystemElevation Spine20252—
+6K243816Testa TP Pivoting Spacer SystemSpine Wave, Inc.20250—
+6K251644ProAM ALIF SystemPro Surgical, Inc.20250—
+6K250845Curiteva Porous PEEK Standalone ALIF SystemCuriteva, Inc.20251—
+6K251617X-PAC® TLIF Expandable Posterior Cage System; X-PAC® LLIF Expandable Lateral Cage SystemExpanding Innovations, Inc.20250—
+6K251459OneLIF™ Interbody Fusion SystemNovapproach Spine, LLC20250—
+6K243116FlareHawk Interbody Fusion SystemIntegrity Implants Inc. Dba Accelus20250—
+6K250602X-PAC® N-GAGE™ Lumbar Plate SystemExpanding Innovations, Inc.20250—
+6K243934Stable-L Lumbar Interbody SystemNexus Spine, LLC20250—
+6K251117Cervical Spine Truss System (CSTS)4Web Medical20250—
+6K242928Tesera-k SC SystemKyocera Medical Technologies, Inc.20250—
+6K250521NanoBone® SBX Putty ; NanoBone® QDBiocomposites, Ltd.20250—
+6K250603AxTiHA® Stand-Alone ALIF SystemInnovasis20250—
+6K250556Porous Biologic ScaffoldVentris Medical20250—
+6K243461Calibrate Interbody SystemsAlphatec Spine, Inc.20250—
+6K243915FIX-C 3D Ti ACIF SystemJeil Medical Corporation20250—