510(k) Report

Devices descending from K020048

1,559 later devices reach Modification to Geo Structure through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+5K172676NuVasive® Modulus-C Interbody SystemNu Vasive, Incorporated2017125—
+5K173153Vertera Spine™ Coalesce™ Thoracolumbar Interbody Fusion SystemNu Vasive, Incorporated2017160—
+5K172437CONSTRUX® Mini PTC Spacer System, FORZA® PTC Spacer System, PILLAR® SA PTC Spacer SystemOrthofix, Inc.2017143
+5K172341NuVasive® Modulus TLIF Interbody SystemNu Vasive, Incorporated2017163—
+5K172123NuVasive® Modulus XLIF Interbody SystemNu Vasive, Incorporated2017227—
+5K171519FLXfit™Expanding Orthopedics, Inc.2017711
+5K171686Choice Spine Hawkeye™ Vertebral Body Replacement (VBR) SystemChoicespine2017116—
+5K171351Posterior Spine Truss System (PSTS) Interbody Fusion Device4Web, Inc.20177—
+5K171704CAPRI Corpectomy Cage SystemK2m201710—
+5K171140Matrixx SystemNexxt Spine, LLC2017145—
+5K170919The TiBow Expandable Spacer SystemLife Spine, Inc.20171—
+5K170318NeoFuse Ti3D PLIF/TLIF/Cervical InterbodyHt Medical, LLC201749—
+5K170503EIT Cellular Titanium Cervical Cage, EIT Cellular Titanium PLIF Cages, EIT Cellular…Eit Emerging Implant Technologies GmbH20171992
+5K171097MOJAVE Expandable Interbody SystemK2m, Inc.201717—
+5K170455MectaLIF Anterior Stand AloneMedacta International S.A.20174—
+5K162918Atlas Spine Expandable Interbody SystemAtlas Spine, Inc.201729—
+5K160976Altus Spine Interbody Fusion SystemAltus Partners, LLC20178—
+5K162446FORZA Spacer System, PILLAR PEEK Spacer System, PILLAR SA PEEK Spacer System, SKYHAWK…Orthofix, Inc.20166—
+5K161993Leva® Anterior Interbody SystemSpine Wave, Inc.20160—
+5K162431Luna 3D Interbody Fusion SystemBenvenue Medical, Inc.20163—
+5K161888JULIET® LL Lateral Lumbar CageSpineart2016145—
+5K161129Pillar SA PTCOrthofix, Inc.201619—
+5K153495Avenue L Lateral Lumbar Cage, Avenue T TLIF Cage System, ROI-A ALIF Cage System, ROI-T…Ldr Spine USA20161891
+5K151406Cogent Lateral Interbody SystemCogent Spine, LLC201611—
+5K160291Optimus ALIF SystemAmendia, Inc.20160—
+5K151481Sahara Stabilization SystemK2m, Inc.20155—
+5K152259InFill Interbody Fusion DevicePinnacle Spine Group, LLC20152—
+5K151140LnK Lumbar Interbody Fusion Cage SystemL&K BIOMED Co., Ltd.201529—
+5K151374NuVasive MLX-Medial Lateral Expandable Lumbar Interbody System, NuVasive AP Expandable…Nu Vasive, Incorporated2015235—
+5K142193Cogent Med-Lif XLCogent Spine, LLC201412—
+5K141443Infront Lumbar Interbody Fusion SystemInfront Medical, LLC20142—
+5K130254Prow FusionNlt Spine, Ltd.20138—
+5K130820Expandable Lumbar Interbody SystemNu Vasive, Incorporated2013593—
+5K123913Latis SpacerGlobus Medical, Inc.201388—
+5K120464Innesis Peek CageBk Meditech, Co., Ltd.20136—
+5K121581Box Peek VBR System,Innovasis, Inc.20121—
+5K120345Honour Spacer SystemNexxt Spine, LLC2012212—
+5K112014Zyston Straight Spacer SystemBiomet Spine2011174—
+5K111439Chesapeake (Cervical Components)K2m, Inc.20113451
+5K102315Staxx XDL SystemSpine Wave, Inc.20113—
+5K110843Aleutian Spacer SystemK2m, Inc.2011589—
+5K103666Lanx LateralLanx, Inc.2011238—
+5K102322Stingray Cervical Cage; Shark Implant (Plif); Bull Shark Implant (Plif); Tiger Implant…Omni Surgical, L.P.20116—
+5K100037Advanced Vertebral Solutions Express BFDAdvanced Vertebral Solutions, LLC20100—
+5K100820Wenzel Spine Varilift Interbody Fusion SystemWenzel Spine201016—
+5K092211Chesapeake Spinal SystemK2m, Inc.2010450—
+5K082698Aleutian Ibf SystemK2m, Inc.2009662—
+5K081880Atlas Spine SpacerAtlas Spine, Inc.20080—
+5K073177Pioneer Intervertebral Fusion Device SystemPioneer Surgical Technology20087751
+5K080401Shell Cage, Wave Cage, Loop CageAdvanced Medical Technologies AG2008840—
+5K073291Capstone Spinal SystemMedtronic Sofamor Danek USA, Inc.20081,103—
+5K080083Intrepid Spinal SystemMedtronic Sofamor Danek20089328
+5K073502Vertebron VBR SystemVertebron, Inc.200812—
+5K071497Atlas Spine Vertebral Body ReplacementAtlas Spine, Inc.20070—
+5K063399Aleutian Spacer SystemK2m, Inc.2007663—
+5K060762Aesculap Peek Vertebral Body Replacement SystemAesculap, Inc.2006789—
+5K062132Avs PL Peek Spacer SystemStryker Spine2006243—
+5K061836Avs Asl Peek Spacer SystemStryker Spine2006213—
+5K060506Stryker Spine Vlift Vertebral Body Replacement SystemStryker Spine2006270—
+5K053508Synfix-LRSynthes Spine Co.Lp2006391
+5K051781Graftcage TLXOsteotech, Inc.20050Class I
+6K261430TruLift Expandable SystemLife Spine, Inc.20260—
+6K2530413d Cage CervicalFims Co., Ltd.20260—
+6K261279DeltaNEC Interbody SystemNexus Spine20260—
+6K252982CONDUIT™ ZERO-P™ VA Secured Spacer SystemAvalign Technologies, Inc.20260—
+6K260810Anteralign LS coverplateTyber Medical, LLC20260—
+6K253894BMD Titanium Spinal Fusion SystemGlobal Biomedica s.r.o.20260—
+6K260837VersaLift Expandable SystemLife Spine, Inc.20260—
+6K261067BEE PLIF CageNGMedical GmbH20260—
+6K253401SCRIPT™ Implant SystemGlobus Medical, Inc.20260—
+6K260340HC Biologics Osteopoint Peek Cages, HC Biologics Osteopoint Cervical Peek Cages, HC…HC Biologics, LLC20260—
+6K252432Flex-Z™ Cervical CageSpinepoint, LLC20260—
+6K254105Hive™ Standalone Cervical System and Hive™ C Interbody SystemNanoHive Medical, LLC20260—
+6K253545Vulcan Spinal SystemK2m, Inc.20260—
+6K252205Curiteva Porous PEEK Cervical Interbody System; Curiteva Porous PEEK Lumbar Interbody…Curiteva, Inc.20260—
+6K252711Advantage-C™ Ti3D Cervical Interbody Fusion DeviceIntelivation Technologies20260—
+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—
+6K250599ExcelsiusGPS™ InstrumentsGlobus Medical, Inc.20250—
+6K251479Mobarn 80:20 Lumbar Interbody Fusion System (Posterior Lumbar Interbody Fusion Cage…Mobarn Medical Devices, LLC20250—
+6K251444Endoskeleton™ Interbody SystemsMedtronic Sofamor Danek USA, Inc.20250—
+6K252113PRADO™ Lumbar Interbody Fusion SystemBethesda Medical Devices20250—
+6K250072CONDUIT™ SYNFIX™ Evolution Secured Spacer SystemAvalign Technologies, Inc.20251—
+6K251741PathLoc Lumbar Interbody Fusion Cage SystemL&K BIOMED Co., Ltd.20250—
+6K251431FIX-C PEEK ACIF SA SystemJeil Medical Corporation20250—
+6K250845Curiteva Porous PEEK Standalone ALIF SystemCuriteva, Inc.20251—
+6K243934Stable-L Lumbar Interbody SystemNexus Spine, LLC20250—
+6K250669Adaptix™ Interbody System with Titan nanoLOCK™ Surface TechnologyMedtronic Sofamor Danek USA, Inc.20250—
+6K250373ProLift Expandable Spacer SystemLife Spine, Inc.20251—
+6K243074Spectrum Spine Lumbar Cage SystemSpectrum Spine, Inc.20252—
+6K250667DeGen Medical Patient Specific Implant (PSI) SystemDegen Medical20251—
+6K243668ProLift Pivot Expandable Spacer SystemLife Spine, Inc.20250—
+6K242517ProAM ACDF SystemPro Surgical, Inc.20240—
+6K242260aprevo® Cervical ACDF; aprevo® Cervical ACDF-X; aprevo® Cervical ACDF-X NO CAMCarlsmed, Inc.20243—
+6K241468Vertiwedge® Intraosseous SystemFoundation Surgical Group, Inc.20241—
+6K242734ZSFab Cervical Interbody System; ZSFab Lumbar Interbody SystemZsfab20243—
+6K242589Scarlet® AL-TSpineart SA20240—
+6K242829BluEX Lumbar Expandable Cage SystemL&K BIOMED Co., Ltd.20240—
+6K242267Gemini Medical Cage SystemZheJiang Decans Medical Devices Co., Ltd.20241—
+6K242826ProLift Wedge Expandable Spacer SystemLife Spine, Inc.20240—