510(k) Report

Devices descending from K072226

812 later devices reach Impix Spacer through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K163595IMPIX 3D Print CagesMedicrea International SA2017282
+1K141187Impix Alif S/aMedicrea International SA201501
+1K132483Innesis Peek Cervical CageBk Meditech, Co., Ltd.20140—
+1K130853Idys (TM) CClariance20132—
+1K110067LP CageMedyssey Co, Ltd.201115—
+1K100544Impix Lumbar Interbody DeviceMedicrea Technologies201001
+1K083798Impix Alif Lumbar Ibf, Impix Alif-D Lumbar Ibf, Impix Tlif Lumbar IbfMedicrea Technologies2010322
+1K083167Phenix Cervical Interbody DeviceSpinal Devices, LLC200914—
+1K081196Spinal Usa VBR SystemSpinal USA200813—
+1K081880Atlas Spine SpacerAtlas Spine, Inc.20080—
+1K073177Pioneer Intervertebral Fusion Device SystemPioneer Surgical Technology20087751
+2K241164IB3D™ PL Spinal SystemMedicrea International S.A.S. (Medtronic)202412
+2K223654Medussa-PL CageMedyssey USA, Inc.20220—
+2K212075ShurFit Lumbar Interbody SystemPrecision Spine, Inc.20211—
+2K212562Idys-C ZP 3DTiClariance, SA20211—
+2K191134IB3D AlifMedicrea International SA20191—
+2K182158UNiD Patient-matched PLIF cageMedicrea International SA201921—
+2K190092UNiD Patient specific 3D printed TLIF cageMedicrea International SA201913—
+2K173782UNiD Patient Specific 3D printed cageMedicrea International SA201823—
+2K170341Medussa-PL CageMedyssey USA, Inc.20174—
+2K170643Interbody Fusion (IBF)/Vertebral Body Replacement (VBR) SystemRti Surgical, Inc. Dba Rti Biologics201711—
+2K150500Px PEEK IBF SystemInnovasis, Inc.201558—
+2K150521Interbody Fusion (IBF)/Vertebral Body Replacement (VBR) SystemRti Surgical, Inc. Dba Rti Biologics201512—
+2K142456GPS SpacersG Surgical, LLC20151—
+2K140564BN Lumbar Cage SystemMedyssey USA, Inc.20143—
+2K133455Crossfuse II Coronal Taper, Crossfuse II HyperlordoticPioneer Surgical Technology, Inc.20145961
+2K133623C-PLUSPioneer Surgical Technology, Inc.2014598—
+2K130948C-Fuse Cervical Intervertebral Body Fusion SystemSouthern Spine, LLC201313—
+2K120464Innesis Peek CageBk Meditech, Co., Ltd.20136—
+2K121246Medyssy LT Cage SystemMedyssey Co, Ltd.20122—
+2K120396Reliance Cervical Ibf SystemReliance Medical Systems, LLC201225—
+2K112862Mecta-CMedacta International201114—
+2K110442Nanovis Intervertebral Body Fusion SystemNanovis, LLC201110—
+2K112496Pioneer Crossfuse II Ibf/VBR SystemPioneer Surgical Technology, Inc.2011604—
+2K103111Forza Spacer SystemOrthofix, Inc.20113431
+2K100210TRANS1 Lateral Intervertebral Fusion Device, TTrans1 Incorporated2010175—
+2K092540C-PS Peek Optima Cervical Interbody Spacer, L-PS Peek Optima Lumbar Interbody SpacerRsb Spine, LLC201045—
+3K253577IB3D™ PL Spinal System (A24000000 / IB3D Universal Implant Inserter)Medicrea International S.A.S. (Medtronic)20250—
+3K241077DeGen Medical Patient Specific Implant (PSI) SystemDegen Medical20242—
+3K240566Reef L Interbody System; WaveForm L Interbody SystemSeaSpine Orthopedics Corporation20245—
+3K240715Idys® C ZP 3DTiClariance20240—
+3K221172FOCUS Interbody SystemOc Medical Devices20220—
+3K202266Reliance Cervical IBF SystemReliance Medical Systems, LLC20223—
+3K213493Fortilink with TiPlus TechnologyParadigm Spine20220—
+3K210542aprevo Transforaminal IBFCarlsmed, Inc.202112—
+3K210890GPS Cervical SpacersG Surgical, LLC20210—
+3K202034aprevo Intervertebral Body Fusion DeviceCarlsmed, Inc.202017—
+3K200316UNiD IB3D ALIFMedicrea International SA20200—
+3K200283Medussa-PL CageMedyssey USA, Inc.20200—
+3K191822Nano FortiCore, FortiCoreNanovis, LLC20192—
+3K180228II-Type Intervertebral SpacerPaonan Biotech Co., Ltd.20191—
+3K180990TirboLOX-L Lumbar IBFDCaptiva Spine, Inc.20181—
+3K180675Atlas Spine Expandable Cervical Interbody SystemAtlas Spine, Inc.20182—
+3K180078Px PEEK IBF System, Px HA PEEK IBF System, TxHA PEEK IBF SystemInnovasis, Inc.2018551
+3K173102Reliance Cervical IBF SystemReliance Medical Systems, LLC201715—
+3K170389TAURUS PEEK Cage SystemMedyssey USA, Inc.20170—
+3K172756Varian cageMedyssey USA, Inc.20171—
+3K172343Fortilink® Interbody Fusion (IBF) System with TETRAfuse® 3D TechnologyRti Surgical, Inc.201710—
+3K172587Mecta-C with titanium markers and Mecta-C TiPEEK with titanium markersMedacta International S.A.20170—
+3K172489Reliance Cervical IBF SystemReliance Medical Systems, LLC201716—
+3K163673Fortilink™-C with TETRAfuse™ 3D TechnologyRti Surgical, Inc.201711—
+3K160222OIC Cervical PEEK SpacerThe Orthopaedic Implant Company20160—
+3K153665Prow Fusion-LNlt Spine, Ltd.20160—
+3K161485Nanovis Intervertebral Body Fusion System and Forticore (R)Nanovis, LLC20165—
+3K160874Nanovis Intervertebral Body Fusion System and FortiCore®Nanovis, LLC20164—
+3K153107Choice Spine Lumbar Spacer System (Sabre™, Shark™, Hornet™, Harpoon™), Choice Spine VEO™…Choicespine, LP2016171—
+3K152475FORZA PTC Spacer SystemOrthofix, Inc.2016236—
+3K151785Px HA PEEK IBF SystemInnovasis, Inc.201557—
+3K151408LOSPA IS Spinal SystemCorentec Co., Ltd.20151—
+3K142269Reliance Cervical IBF SystemReliance Medical Systems, LLC201523—
+3K142744Mecta-C TiPEEKMedacta International201512—
+3K143258PLIF STS, TLIF STS, OLIF STS (Spinal Truss System)4Web, Inc.2015211—
+3K141665NuVasive CoRoent SystemNuvasive, Inc.2015588—
+3K140577Innesis Peek TL CageBk Meditech, Co., Ltd.20142—
+3K140280ForticoreNanovis, LLC20149—
+3K141129Exactech Cervical Spacer SystemExactech, Inc.20148—
+3K140709Skyhawk Interbody Fusion SystemOrthofix, Inc.20147—
+3K123607Octane Elevate Spinal Implant SystemExactech, Inc.20141—
+3K131429Reliance Cervical Ibf SystemReliance Medical Systems, LLC201324—
+3K123997TRANS1LATERAL Interbody Fusion SystemTrans1, Inc.2013173—
+3K121116Plateau Spacer SystemLife Spine201213—
+3K120656Everest Spinal SystemK2m, Inc.201243—
+4K253420Admiral ACP System; Explorer TO System; Laminoplasty System; Manta Ray TDF Spacer…SeaSpine Orthopedics Corporation20260—
+4K260840BluEX Cervical Expandable Cage SystemL&K BIOMED Co., Ltd.20261—
+4K252781MSFX Mikron Peek CagesMikron Makina Sanayi VE Tic. Ltd. Sti.20251—
+4K250667DeGen Medical Patient Specific Implant (PSI) SystemDegen Medical20251—
+4K242260aprevo® Cervical ACDF; aprevo® Cervical ACDF-X; aprevo® Cervical ACDF-X NO CAMCarlsmed, Inc.20243—
+4K240889ARTFX Lumbar PEEK CagesArtfx Medical20244—
+4K233807LumiVy™ Lumbar IBF SystemVy Spine, LLC20241—
+4K241605Adaptix™ PEEK Interbody System with Nanotechnology; Capstone Control™ PEEK Spinal System…Nanovis, LLC20240—
+4K241019aprevo® TLIF-C Articulating SystemCarlsmed20244—
+4K241466Shoreline ACS Interbody System; Shoreline RT Interbody System; Regatta Lateral System…SeaSpine Orthopedics Corporation20243—
+4K233075“BioGend” Interbody Fusion System 001 CageBiogend Therapeutics Co., Ltd.20240—
+4K231836ClariVy™ Cervical IBF SystemVy Spine, LLC20232—
+4K230936Anatomic PEEK™ Cervical Fusion System with NanotechnologyNanovis, LLC20230—
+4K230026SqualeImplanet, S.A.20230—
+4K222009aprevo® anterior lumbar interbody fusion device with interfixationCarlsmed, Inc.202212—
+4K221162UniVy OsteoVy Cervical IBF SystemVy Spine, LLC20222—
+4K222203DualXSLIM (R) T/PLIFAmplify Surgical, Inc.20223—
+4K220953ChoiceSpine TigerShark™ M, Modular Interbody SystemChoice Spine, LLC20220—