510(k) Report

Devices descending from K061151

801 later devices reach Pioneer Vertebral Spacer (Vertebral Spacer) through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K170643Interbody Fusion (IBF)/Vertebral Body Replacement (VBR) SystemRti Surgical, Inc. Dba Rti Biologics201711—
+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—
+1K131724Pioneer Maxfuse Vertebral Body Replacement DevicePioneer Surgical Technology, Inc.201373—
+1K112496Pioneer Crossfuse II Ibf/VBR SystemPioneer Surgical Technology, Inc.2011604—
+1K073177Pioneer Intervertebral Fusion Device SystemPioneer Surgical Technology20087751
+1K063464Atlas Spine Vertebral Body ReplacementAtlas Spine, Inc.20072—
+2K213493Fortilink with TiPlus TechnologyParadigm Spine20220—
+2K202034aprevo Intervertebral Body Fusion DeviceCarlsmed, Inc.202017—
+2K172343Fortilink® Interbody Fusion (IBF) System with TETRAfuse® 3D TechnologyRti Surgical, Inc.201710—
+2K163673Fortilink™-C with TETRAfuse™ 3D TechnologyRti Surgical, Inc.201711—
+2K142005SpineFab Vertebral Body Replacement (VBR) SystemOxford Performance Materials201513—
+2K150500Px PEEK IBF SystemInnovasis, Inc.201558—
+2K141665NuVasive CoRoent SystemNuvasive, Inc.2015588—
+2K142030STGC-LordoticCardinal Spine, LLC201558—
+2K120396Reliance Cervical Ibf SystemReliance Medical Systems, LLC201225—
+2K121116Plateau Spacer SystemLife Spine201213—
+2K112862Mecta-CMedacta International201114—
+2K103111Forza Spacer SystemOrthofix, Inc.20113431
+2K100210TRANS1 Lateral Intervertebral Fusion Device, TTrans1 Incorporated2010175—
+2K100544Impix Lumbar Interbody DeviceMedicrea Technologies201001
+2K092540C-PS Peek Optima Cervical Interbody Spacer, L-PS Peek Optima Lumbar Interbody SpacerRsb Spine, LLC201045—
+2K081880Atlas Spine SpacerAtlas Spine, Inc.20080—
+2K071497Atlas Spine Vertebral Body ReplacementAtlas Spine, Inc.20070—
+3K253158VyBrate™ VBR SystemVy Spine, LLC20260—
+3K242260aprevo® Cervical ACDF; aprevo® Cervical ACDF-X; aprevo® Cervical ACDF-X NO CAMCarlsmed, Inc.20243—
+3K233807LumiVy™ Lumbar IBF SystemVy Spine, LLC20241—
+3K241019aprevo® TLIF-C Articulating SystemCarlsmed20244—
+3K240566Reef L Interbody System; WaveForm L Interbody SystemSeaSpine Orthopedics Corporation20245—
+3K231836ClariVy™ Cervical IBF SystemVy Spine, LLC20232—
+3K230026SqualeImplanet, S.A.20230—
+3K222009aprevo® anterior lumbar interbody fusion device with interfixationCarlsmed, Inc.202212—
+3K222082aprevo® anterior and lateral lumbar interbody fusion devices, aprevo® transforaminal…Carlsmed, Inc.202211—
+3K202266Reliance Cervical IBF SystemReliance Medical Systems, LLC20223—
+3K210542aprevo Transforaminal IBFCarlsmed, Inc.202112—
+3K210214NuVasive Modulus Expandable Posterior Lumbar MOD-EX PL Interbody SystemNu Vasive, Incorporated20213—
+3K201500Life Spine Plateau-A Ti Anterior Lumbar Spacer & Plateau-X Ti Lateral Lumbar SpacerLife Spine, Inc.20203—
+3K193541NuVasive Cohere Thoracolumbar Interbody SystemNu Vasive, Incorporated2020157—
+3K192718Fortilink Interbody Fusion Device (IBF) with TETRAfuse 3D TechnologyPioneer Surgical Technology, Inc., Dba Rti Surgical, Inc.20195—
+3K190498Fortilink® IBF System with TETRAfuse®3D Technology, include the following designs…Pioneer Surgical Technology, Inc., Dba Rti Surgical, Inc.20197—
+3K180228II-Type Intervertebral SpacerPaonan Biotech Co., Ltd.20191—
+3K181860NuVasive Cohere Thoracolumbar Interbody SystemNu Vasive, Incorporated2018159—
+3K180078Px PEEK IBF System, Px HA PEEK IBF System, TxHA PEEK IBF SystemInnovasis, Inc.2018551
+3K173102Reliance Cervical IBF SystemReliance Medical Systems, LLC201715—
+3K173182ProLift® Expandable SystemLife Spine, Inc.201737—
+3K172009Cascadia Interbody SystemK2m, Inc.2017433
+3K172341NuVasive® Modulus TLIF Interbody SystemNu Vasive, Incorporated2017163—
+3K171633NuVasive TLX Interbody SystemNu Vasive, Incorporated2017251—
+3K172587Mecta-C with titanium markers and Mecta-C TiPEEK with titanium markersMedacta International S.A.20170—
+3K172489Reliance Cervical IBF SystemReliance Medical Systems, LLC201716—
+3K163230NuVasive Modulus XLIF Interbody SystemNu Vasive, Incorporated2017276—
+3K160222OIC Cervical PEEK SpacerThe Orthopaedic Implant Company20160—
+3K161379ELSA SpacersGlobus Medical, Inc.2016155—
+3K153665Prow Fusion-LNlt Spine, Ltd.20160—
+3K161223TransContinental® M Spacers and InterContinental® Plate-SpacersGlobus Medical, Inc.2016117—
+3K153786Prow Fusion-VNlt Spine, Ltd.20166—
+3K153107Choice Spine Lumbar Spacer System (Sabre™, Shark™, Hornet™, Harpoon™), Choice Spine VEO™…Choicespine, LP2016171—
+3K153782NuVasive® Lumbar Interbody ImplantsNu Vasive, Incorporated2016390—
+3K153627NuVasive® TLX Interbody SystemNu Vasive, Incorporated2016252—
+3K152568C-VBRCardinal Spine, LLC201657—
+3K152475FORZA PTC Spacer SystemOrthofix, Inc.2016236—
+3K151310Amendia Interbody Fusion DevicesAmendia, Inc.2016169—
+3K151785Px HA PEEK IBF SystemInnovasis, Inc.201557—
+3K151408LOSPA IS Spinal SystemCorentec Co., Ltd.20151—
+3K151472NuVasive CoRoent Lumbar SystemNu Vasive, Incorporated2015479—
+3K151322Amendia Interbody Fusion DevicesAmendia, Inc.20152261
+3K150994NuVasive CoRoent Thoracolumbar ImplantsNu Vasive, Incorporated2015402—
+3K142269Reliance Cervical IBF SystemReliance Medical Systems, LLC201523—
+3K142744Mecta-C TiPEEKMedacta International201512—
+3K143595NuVasive (R) CCX-L Interbody SystemNu Vasive, Incorporated2015253—
+3K143258PLIF STS, TLIF STS, OLIF STS (Spinal Truss System)4Web, Inc.2015211—
+3K140709Skyhawk Interbody Fusion SystemOrthofix, Inc.20147—
+3K132483Innesis Peek Cervical CageBk Meditech, Co., Ltd.20140—
+3K131429Reliance Cervical Ibf SystemReliance Medical Systems, LLC201324—
+3K131077Life Spine Plateau Spacer SystemLife Spine201310—
+3K123997TRANS1LATERAL Interbody Fusion SystemTrans1, Inc.2013173—
+3K120656Everest Spinal SystemK2m, Inc.201243—
+4K261049Scala® TLSpineart SA20260—
+4K253420Admiral ACP System; Explorer TO System; Laminoplasty System; Manta Ray TDF Spacer…SeaSpine Orthopedics Corporation20260—
+4K253401SCRIPT™ Implant SystemGlobus Medical, Inc.20260—
+4K252781MSFX Mikron Peek CagesMikron Makina Sanayi VE Tic. Ltd. Sti.20251—
+4K250599ExcelsiusGPS™ InstrumentsGlobus Medical, Inc.20250—
+4K250827aprevo® anterior lumbar interbody fusion device; aprevo® lateral lumbar interbody fusion…Carlsmed, Inc.20252—
+4K250987aprevo® posterior/transforaminal lumbar interbody fusion deviceCarlsmed, Inc.20251—
+4K250186GoLIF! Lumbar Interbody Fusion SystemGetset Surgical, SA20250—
+4K242771Tesera-k PL System and Tesera-k XL SystemKyocera Medical Technologies, Inc.20251—
+4K241783FortiVy™ OsteoVy™ Lumbar IBFVy Spine, LLC20250—
+4K241477aprevo® anterior lumbar interbody fusion device with interfixationCarlsmed, Inc.20246—
+4K242826ProLift Wedge Expandable Spacer SystemLife Spine, Inc.20240—
+4K240889ARTFX Lumbar PEEK CagesArtfx Medical20244—
+4K241332aprevo® anterior and lateral lumbar interbody fusion device; aprevo® anterior lumbar…Carlsmed, Inc.20245—
+4K234035COSINE™ SpacerGlobus Medical, Inc.20240—
+4K241605Adaptix™ PEEK Interbody System with Nanotechnology; Capstone Control™ PEEK Spinal System…Nanovis, LLC20240—
+4K241328aprevo® Anterior and Lateral Lumbar Interbody Fusion device (ALIF/LLIF); aprevo®…Carlsmed, Inc.20240—
+4K241466Shoreline ACS Interbody System; Shoreline RT Interbody System; Regatta Lateral System…SeaSpine Orthopedics Corporation20243—
+4K232282aprevo® anterior and lateral lumbar interbody fusion device, aprevo® transforaminal…Carlsmed, Inc.20240—
+4K233075“BioGend” Interbody Fusion System 001 CageBiogend Therapeutics Co., Ltd.20240—
+4K233735ADIRA™ Lateral Plate SystemGlobus Medical, Inc.20240—
+4K232292Peridot-EX Expandable Intervertebral Body Fusion SystemGbs Commonwealth Co., Ltd.20230—