510(k) Report

Devices descending from K073177

775 later devices reach Pioneer Intervertebral Fusion Device System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K170643Interbody Fusion (IBF)/Vertebral Body Replacement (VBR) SystemRti Surgical, Inc. Dba Rti Biologics201711—
+1K150500Px PEEK IBF SystemInnovasis, Inc.201558—
+1K150521Interbody Fusion (IBF)/Vertebral Body Replacement (VBR) SystemRti Surgical, Inc. Dba Rti Biologics201512—
+1K133455Crossfuse II Coronal Taper, Crossfuse II HyperlordoticPioneer Surgical Technology, Inc.20145961
+1K133623C-PLUSPioneer Surgical Technology, Inc.2014598—
+1K120396Reliance Cervical Ibf SystemReliance Medical Systems, LLC201225—
+1K112862Mecta-CMedacta International201114—
+1K112496Pioneer Crossfuse II Ibf/VBR SystemPioneer Surgical Technology, Inc.2011604—
+1K103111Forza Spacer SystemOrthofix, Inc.20113431
+1K100210TRANS1 Lateral Intervertebral Fusion Device, TTrans1 Incorporated2010175—
+1K100544Impix Lumbar Interbody DeviceMedicrea Technologies201001
+1K092540C-PS Peek Optima Cervical Interbody Spacer, L-PS Peek Optima Lumbar Interbody SpacerRsb Spine, LLC201045—
+2K240566Reef L Interbody System; WaveForm L Interbody SystemSeaSpine Orthopedics Corporation20245—
+2K202266Reliance Cervical IBF SystemReliance Medical Systems, LLC20223—
+2K213493Fortilink with TiPlus TechnologyParadigm Spine20220—
+2K202034aprevo Intervertebral Body Fusion DeviceCarlsmed, Inc.202017—
+2K180228II-Type Intervertebral SpacerPaonan Biotech Co., Ltd.20191—
+2K180078Px PEEK IBF System, Px HA PEEK IBF System, TxHA PEEK IBF SystemInnovasis, Inc.2018551
+2K173102Reliance Cervical IBF SystemReliance Medical Systems, LLC201715—
+2K172343Fortilink® Interbody Fusion (IBF) System with TETRAfuse® 3D TechnologyRti Surgical, Inc.201710—
+2K172587Mecta-C with titanium markers and Mecta-C TiPEEK with titanium markersMedacta International S.A.20170—
+2K172489Reliance Cervical IBF SystemReliance Medical Systems, LLC201716—
+2K163673Fortilink™-C with TETRAfuse™ 3D TechnologyRti Surgical, Inc.201711—
+2K160222OIC Cervical PEEK SpacerThe Orthopaedic Implant Company20160—
+2K153665Prow Fusion-LNlt Spine, Ltd.20160—
+2K153107Choice Spine Lumbar Spacer System (Sabre™, Shark™, Hornet™, Harpoon™), Choice Spine VEO™…Choicespine, LP2016171—
+2K152475FORZA PTC Spacer SystemOrthofix, Inc.2016236—
+2K151785Px HA PEEK IBF SystemInnovasis, Inc.201557—
+2K151408LOSPA IS Spinal SystemCorentec Co., Ltd.20151—
+2K142269Reliance Cervical IBF SystemReliance Medical Systems, LLC201523—
+2K142744Mecta-C TiPEEKMedacta International201512—
+2K143258PLIF STS, TLIF STS, OLIF STS (Spinal Truss System)4Web, Inc.2015211—
+2K141665NuVasive CoRoent SystemNuvasive, Inc.2015588—
+2K140709Skyhawk Interbody Fusion SystemOrthofix, Inc.20147—
+2K132483Innesis Peek Cervical CageBk Meditech, Co., Ltd.20140—
+2K131429Reliance Cervical Ibf SystemReliance Medical Systems, LLC201324—
+2K123997TRANS1LATERAL Interbody Fusion SystemTrans1, Inc.2013173—
+2K121116Plateau Spacer SystemLife Spine201213—
+2K120656Everest Spinal SystemK2m, Inc.201243—
+3K253420Admiral ACP System; Explorer TO System; Laminoplasty System; Manta Ray TDF Spacer…SeaSpine Orthopedics Corporation20260—
+3K252781MSFX Mikron Peek CagesMikron Makina Sanayi VE Tic. Ltd. Sti.20251—
+3K242260aprevo® Cervical ACDF; aprevo® Cervical ACDF-X; aprevo® Cervical ACDF-X NO CAMCarlsmed, Inc.20243—
+3K240889ARTFX Lumbar PEEK CagesArtfx Medical20244—
+3K233807LumiVy™ Lumbar IBF SystemVy Spine, LLC20241—
+3K241019aprevo® TLIF-C Articulating SystemCarlsmed20244—
+3K241466Shoreline ACS Interbody System; Shoreline RT Interbody System; Regatta Lateral System…SeaSpine Orthopedics Corporation20243—
+3K233075“BioGend” Interbody Fusion System 001 CageBiogend Therapeutics Co., Ltd.20240—
+3K231836ClariVy™ Cervical IBF SystemVy Spine, LLC20232—
+3K230026SqualeImplanet, S.A.20230—
+3K222009aprevo® anterior lumbar interbody fusion device with interfixationCarlsmed, Inc.202212—
+3K221162UniVy OsteoVy Cervical IBF SystemVy Spine, LLC20222—
+3K222203DualXSLIM (R) T/PLIFAmplify Surgical, Inc.20223—
+3K222082aprevo® anterior and lateral lumbar interbody fusion devices, aprevo® transforaminal…Carlsmed, Inc.202211—
+3K220523restor3d TiDAL Lumbar Interbody Fusion DeviceRestor3D20222—
+3K212358Romero Cervical CageSpineup, Inc.20226—
+3K212715Vy Spine ClariVy Cervical IBF SystemVy Spine, LLC20216—
+3K210542aprevo Transforaminal IBFCarlsmed, Inc.202112—
+3K210214NuVasive Modulus Expandable Posterior Lumbar MOD-EX PL Interbody SystemNu Vasive, Incorporated20213—
+3K202380Born PT-LIF Cage HASpineworxx AG20210—
+3K203683CarboClear Lumbar Cage SystemCarbofix Orthpedics, Ltd.20211—
+3K201939GAIA Lumbar Interbody Fusion Device (LIFD) FamilyPrinterprezz20200—
+3K201500Life Spine Plateau-A Ti Anterior Lumbar Spacer & Plateau-X Ti Lateral Lumbar SpacerLife Spine, Inc.20203—
+3K193541NuVasive Cohere Thoracolumbar Interbody SystemNu Vasive, Incorporated2020157—
+3K193378CarboClear Lumbar Cage SystemCarboFix Orthopedics, Ltd.20202—
+3K192718Fortilink Interbody Fusion Device (IBF) with TETRAfuse 3D TechnologyPioneer Surgical Technology, Inc., Dba Rti Surgical, Inc.20195—
+3K183407Triton CageMedyssey USA, Inc.20190—
+3K191621ChoiceSpine Octane A/T/P Spinal Implant System, ChoiceSpine Cervical Interbody Spacer…Choice Spine, LLC20194—
+3K190498Fortilink® IBF System with TETRAfuse®3D Technology, include the following designs…Pioneer Surgical Technology, Inc., Dba Rti Surgical, Inc.20197—
+3K183064TxTi IBF SystemInnovasis, Inc.2019481
+3K190684LxHA PEEK Lateral IBF SystemInnovasis, Inc.20190—
+3K181860NuVasive Cohere Thoracolumbar Interbody SystemNu Vasive, Incorporated2018159—
+3K171495Zyston Strut Open Titanium Spacer SystemZimmer Biomet Spine, Inc.20181—
+3K173182ProLift® Expandable SystemLife Spine, Inc.201737—
+3K172009Cascadia Interbody SystemK2m, Inc.2017433
+3K172437CONSTRUX® Mini PTC Spacer System, FORZA® PTC Spacer System, PILLAR® SA PTC Spacer SystemOrthofix, Inc.2017143
+3K172341NuVasive® Modulus TLIF Interbody SystemNu Vasive, Incorporated2017163—
+3K171633NuVasive TLX Interbody SystemNu Vasive, Incorporated2017251—
+3K171686Choice Spine Hawkeye™ Vertebral Body Replacement (VBR) SystemChoicespine2017116—
+3K171351Posterior Spine Truss System (PSTS) Interbody Fusion Device4Web, Inc.20177—
+3K170503EIT Cellular Titanium Cervical Cage, EIT Cellular Titanium PLIF Cages, EIT Cellular…Eit Emerging Implant Technologies GmbH20171992
+3K170243LOSPA IS TLIF & DLIF CagesCorentec Co., Ltd.20170—
+3K163230NuVasive Modulus XLIF Interbody SystemNu Vasive, Incorporated2017276—
+3K162918Atlas Spine Expandable Interbody SystemAtlas Spine, Inc.201729—
+3K160976Altus Spine Interbody Fusion SystemAltus Partners, LLC20178—
+3K162446FORZA Spacer System, PILLAR PEEK Spacer System, PILLAR SA PEEK Spacer System, SKYHAWK…Orthofix, Inc.20166—
+3K161809ShurFit CpTi-HA ACIF Interbody Fusion SystemPrecision Spine, Inc.20165—
+3K162103Choice Spine Lumbar Spacer System (Sabre™, Shark™, Hornet™, Harpoon™), Choice Spine…Choicespine, LP2016161—
+3K162431Luna 3D Interbody Fusion SystemBenvenue Medical, Inc.20163—
+3K161379ELSA SpacersGlobus Medical, Inc.2016155—
+3K161129Pillar SA PTCOrthofix, Inc.201619—
+3K160605MectaLIF Anterior Stand-AloneMedacta International201610—
+3K161223TransContinental® M Spacers and InterContinental® Plate-SpacersGlobus Medical, Inc.2016117—
+3K153786Prow Fusion-VNlt Spine, Ltd.20166—
+3K153436LATERAL Spine Truss System4Web, Inc.20165—
+3K153495Avenue L Lateral Lumbar Cage, Avenue T TLIF Cage System, ROI-A ALIF Cage System, ROI-T…Ldr Spine USA20161891
+3K153782NuVasive® Lumbar Interbody ImplantsNu Vasive, Incorporated2016390—
+3K153627NuVasive® TLX Interbody SystemNu Vasive, Incorporated2016252—
+3K151310Amendia Interbody Fusion DevicesAmendia, Inc.2016169—
+3K151472NuVasive CoRoent Lumbar SystemNu Vasive, Incorporated2015479—
+3K151322Amendia Interbody Fusion DevicesAmendia, Inc.20152261