510(k) Report

Devices descending from K072253

1,250 later devices reach Synfix-LR Spacer through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K251575IdentiTi™ II ALIF Standalone Interbody System; Transcend™ ALIF Standalone Interbody SystemAlphatec Spine20250—
+1K180963Roccia Alif, Roccia TlifSilony Medical GmbH20183—
+1K170676HD Lumbar Interbody SystemHd Lifesciences, LLC2017122—
+1K163670Rampart One Lumbar Interbody Fusion DeviceSpineology, Inc.20173—
+1K152620Spine Wave Gen II Expandable Interbody SystemSpine Wave, Inc.20162—
+1K150673SYNFIX Evolution Secured Spacer SystemSynthes (USA) Products, LLC2015137—
+1K142271Zavation Z-Link LumbarZavation, LLC20149—
+1K131276Lateral SynfixSynthes (USA) Products, LLC2014146—
+1K130641Logic Stand-Alone Intervertebral Body Fusion DeviceBinder Biomedical, Inc.20130—
+1K124034Mectalif AnteriorMedacta International201311—
+1K120031Chesapeake Spinal SystemK2m, Inc.2012334—
+1K110783Venus Interbody Fixation System- Venus Plif/Tlif, Alif Peek CageL&K BIOMED Co., Ltd.201138—
+1K102402Solus Anterior Lumbar Interbody Fusion (Alif) Spinal Spacer SystemAlphatec Spine, Inc.20111121
+1K102738Lanx Fusion SystemLanx, LLC20113281
+1K100802Aesculap Implant Systems Sibd Spinal SystemAesculap Implant Systems, Inc.2010461—
+1K100043Coroent XLR Standalone SystemNuvasive, Inc.2010744—
+1K093808Incite Innovation Stand Alone Interbody Fusion DeviceIncite Innovation, LLC2010113—
+1K092211Chesapeake Spinal SystemK2m, Inc.2010450—
+1K091301Life Spine Stand-Alone Spacer SystemLife Spine2009473—
+1K081888Dynamik Intervertebral Body Fusion DeviceSpineart2009282—
+1K081196Spinal Usa VBR SystemSpinal USA200813—
+1K081636Peek-Optima Alif SpacerBiomet Spine2008542—
+1K081395Solitaire Peek-Optima Anterior Spinal SystemBiomet Spine2008854—
+1K080673Interfuse Intervertebral Body Fusion DeviceVertebral Technologies, Inc.2008103—
+1K073177Pioneer Intervertebral Fusion Device SystemPioneer Surgical Technology20087751
+1K080083Intrepid Spinal SystemMedtronic Sofamor Danek20089328
+1K073470Avs PL Peek Spacers, Models 48351XXX and 48353XXXStryker Spine20081,102—
+1K072981Synthes Zero-PSynthes Spine Co.Lp20085462
+2K254202MectaLIF 3D Metal AnteriorMedacta International S.A.20260—
+2K253213SAGI Cervical Cage SystemZheJiang Decans Medical Devices Co., Ltd.20260—
+2K250072CONDUIT™ SYNFIX™ Evolution Secured Spacer SystemAvalign Technologies, Inc.20251—
+2K231241NanoHive Medical Lumbar Interbody SystemNanoHive Medical, LLC20230—
+2K230731Zavation ALIF SystemZavation Medical Products, LLC20232—
+2K221545MectaLIF Anterior ExtensionMedacta International S.A.202226
+2K213441PathLoc Lumbar Interbody Fusion Cage SystemL&K BIOMED Co., Ltd.20222—
+2K212075ShurFit Lumbar Interbody SystemPrecision Spine, Inc.20211—
+2K201939GAIA Lumbar Interbody Fusion Device (LIFD) FamilyPrinterprezz20200—
+2K200953NuVasive® Cohere® Thoracolumbar Interbody SystemNu Vasive, Incorporated2020141—
+2K201585Monterey AL Interbody SystemStryker Corporation202044
+2K200541Hive™ Stand-alone Anterior Lumbar Interbody SystemHd Lifesciences, LLC20201—
+2K200048MectaLIF Anterior SimpleMedacta International S.A.20200—
+2K192906Mecta-C Stand AloneMedacta International S.A.20201—
+2K191834Stand-Alone ALIF Titanium SystemLife Spine, Inc.20190—
+2K190708AccelFix Lumbar Interbody Fusion Cage SystemL&K BIOMED Co., Ltd.20195—
+2K191339Zavation eZspand Interbody SystemZavation Medical Products, LLC20195—
+2K190680Favo S-TlifSilony Medical GmbH20190—
+2K183557Endoskeleton® TA Interbody Fusion Device, Endoskeleton® TAS Interbody Fusion Device…Titan Spine, Inc.20191043
+2K181118Reliance Lumbar IBF SystemReliance Medical Systems20190—
+2K182746ATEC ALIF and LLIF Spacer SystemAlphatec Spine, Inc.2018110—
+2K181963ostaPek Interbody Fusion CagesColigne AG20181—
+2K181702Tranquil-L Interbody SystemNexus Spine, LLC20188—
+2K180215DYNA-LINK ELITE Stand-Alone Anterior Lumbar SystemLife Spine, Inc.20182—
+2K181483Tranquil Interbody SystemNexus Spine, LLC20186—
+2K181386NuVasive Brigade Lateral SystemNu Vasive, Incorporated2018158—
+2K180695FBC 921 (Alif)Fbc Device Aps20180—
+2K180364HD LifeSciences Cervical IBFD SystemHd Lifesciences, LLC2018106—
+2K180002Rampart One Lumbar Interbody Fusion DeviceSpineology, Inc.20182—
+2K173082Arco™-SA Lumbar Cage SystemNeurostructures, Inc.20185—
+2K170389TAURUS PEEK Cage SystemMedyssey USA, Inc.20170—
+2K172020Arlington PLIF/TLIF CageSignature Orthopaedics Pty, Ltd.20170—
+2K172019Brisbane ALIF Device, Gladstone ALIF DeviceSignature Orthopaedics Pty, Ltd.20170—
+2K172424Velofix™ SA Cervical CageU&I Corporation201751
+2K170643Interbody Fusion (IBF)/Vertebral Body Replacement (VBR) SystemRti Surgical, Inc. Dba Rti Biologics201711—
+2K162760Spine Wave Anterior Cervical Spine SystemSpine Wave, Inc.20171—
+2K162358T-PAL Spacer System, T-PAL Titanium Spacer System, SYNFIX Evolution SystemSynthes USA Products, LLC2016127—
+2K160605MectaLIF Anterior Stand-AloneMedacta International201610—
+2K153621Juliet® TiSpineart2016751
+2K160051NuVasive® Interfixated Interbody SystemNu Vasive, Incorporated2016396—
+2K152200SurgTech Interbody SystemSurgtech, Inc.20160—
+2K153782NuVasive® Lumbar Interbody ImplantsNu Vasive, Incorporated2016390—
+2K153250Renovis Tesera SC Stand-alone Anterior Cervical Fusion (ACF) SystemRenovis Surgical Technologies201632—
+2K151665SUSTAIN Additional ImplantsGlobus Medical, Inc.2016119—
+2K151481Sahara Stabilization SystemK2m, Inc.20155—
+2K152532AERO -C Cervical Cage SystemStryker Spine2015145—
+2K151408LOSPA IS Spinal SystemCorentec Co., Ltd.20151—
+2K151140LnK Lumbar Interbody Fusion Cage SystemL&K BIOMED Co., Ltd.201529—
+2K151214ALIF Interfixated SystemNu Vasive, Incorporated2015220—
+2K150500Px PEEK IBF SystemInnovasis, Inc.201558—
+2K150135DIVERGENCE-L Anterior/Oblique Lumbar Fusion SystemMedtronic Sofamor Danek USA, Inc.2015228—
+2K150521Interbody Fusion (IBF)/Vertebral Body Replacement (VBR) SystemRti Surgical, Inc. Dba Rti Biologics201512—
+2K142487Chesapeake Stabilization SystemK2m, Inc.201571
+2K141798Sypher Spacer SystemBiogennix, LLC20151—
+2K141135Juliet LLSpineart2014146—
+2K133827A-Link ZOsteo Vasive, LLC2014262
+2K142066Aero-LL Lumbar Cage SystemStryker Corporation20142—
+2K142277Juliet POSpineart2014119—
+2K133494Chesapeake Spinal SystemK2m, Inc.2014330—
+2K140474Juliet OLSpineart2014120—
+2K132738Cogent Med-LifCogent Spine, LLC201413—
+2K133455Crossfuse II Coronal Taper, Crossfuse II HyperlordoticPioneer Surgical Technology, Inc.20145961
+2K133623C-PLUSPioneer Surgical Technology, Inc.2014598—
+2K133557Juliet LL Lateral Lumbar CageSpineart2014147—
+2K133126K7 Lumbar SpacersK7, LLC20131—
+2K131122S128 Anterior Lumbar Interbody Fusion (Alif) SystemRenovis Surgical Technologies, LLC2013269—
+2K122639Synthes Syncage Evolution SpacerSynthes (USA) Products, LLC2013143—
+2K123045Brigade Standalone SystemNuvasive, Inc.2013696—
+2K123767Lanx Fusion System- SALanx, Inc.20133244
+2K123993Solus Anterior Lumbar Interbody Fusion (Alif) SystemAlphatec Spine, Inc.20130—
+2K120869Anchor-L Lumbar CageStryker Spine2012638—
+2K121567Oracle Lumbar Intervertebral Body Fusion Cage SystemAccel Spine20125—