510(k) Report

Devices descending from K020152

1,684 later devices reach Synthes Vertebral Spacer TI through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+5K201087CORBEL SpacersGlobus Medical, Inc.202036—
+5K201614TxTiHA IBF System, AxTiHA Stand-Alone ALIF SystemInnovasis, Inc.2020471
+5K200087F3D Cervical Stand-Alone Interbody Fusion SystemCorelink, LLC202025—
+5K200541Hive™ Stand-alone Anterior Lumbar Interbody SystemHd Lifesciences, LLC20201—
+5K192492EL CAPITAN Anterior Lumber Interbody SystemAstura Medical, LLC202010—
+5K200613Tritanium® X TL Expandable Curved Posterior Lumbar CageStryker Corporation20205—
+5K200052CONSTRUX Mini PTC Spacer System, FORZA PTC Spacer System, PILLAR SA PTC Spacer SystemOrthofix, Inc.202013—
+5K192006SIRION Lateral Lumbar Interbody SystemAstura Medical, LLC202014—
+5K192897icotec Cervical CageIcotec AG20201—
+5K200048MectaLIF Anterior SimpleMedacta International S.A.20200—
+5K192906Mecta-C Stand AloneMedacta International S.A.20201—
+5K192993Scarlet AL-TSpineart20201—
+5K190284Bengal Stackable Cage SystemMedos International SARL20190—
+5K191477AEON-C Stand Alone SystemHuvexel Co., Ltd.201910—
+5K192214CarboClear VBR SystemCarboFix Orthopedics, Ltd.20191—
+5K191537eCarbon IBDsBack 2 Basics Direct, LLC20193—
+5K190877Juliet® Ti LL Lumbar Interbody DeviceSpineart201911
+5K183560Luna 3D GEN2 Interbody Fusion SystemBenvenue Medical, Inc.20192—
+5K182877HALF DOME Posterior Lumbar Interbody SystemAstura Medical, LLC201921—
+5K183426MectaLIF Anterior Stand Alone ExtensionMedacta International S.A.20191—
+5K182920MiRus™ Lumbar Interbody Fusion System consisting of CALLISTO™ PEEK Posterior Lumbar…MiRus, LLC20199—
+5K183588Choice Spine Hawkeye Vertebral Body Replacement (VBR) SystemChoicespine20195—
+5K180665SANTORINI Corpectomy Cage System, CAPRI Corpectomy Cage SystemK2m, LLC20189—
+5K182470Plateau Spacer SystemLife Spine20180—
+5K182195Arco™-SA Lumbar Cage SystemNeurostructures, Inc.20183—
+5K181860NuVasive Cohere Thoracolumbar Interbody SystemNu Vasive, Incorporated2018159—
+5K181328T2 STRATOSPHERE™ Expandable Corpectomy SystemMedtronic Sofamor Danek USA, Inc.201828—
+5K180963Roccia Alif, Roccia TlifSilony Medical GmbH20183—
+5K180675Atlas Spine Expandable Cervical Interbody SystemAtlas Spine, Inc.20182—
+5K173832InTice™-C Porous Ti Cervical Interbody SystemX-Spine Systems, Inc.201801
+5K173347STALIF C FLX, STALIF M FLX, STALIF L FLX and STALIF Lateral-Oblique FLX, ACTILIF C FLX…Centinel Spine, Inc.201812—
+5K173800Camber Spine Technologies SPIRA - V™ Open Matrix Corpectomy CageCamber Spine Technologies20180—
+5K172696FORZA® XP Expandable Spacer SystemOrthofix, Inc.201825—
+5K172349InFill® Interbody Fusion DevicePinnacle Spine Group, LLC20171—
+5K172019Brisbane ALIF Device, Gladstone ALIF DeviceSignature Orthopaedics Pty, Ltd.20170—
+5K171686Choice Spine Hawkeye™ Vertebral Body Replacement (VBR) SystemChoicespine2017116—
+5K171704CAPRI Corpectomy Cage SystemK2m201710—
+5K170830Unison-C Anterior Cervical Fixation SystemPioneer Surgical Technology, Inc., Dba Rti Surgical, Inc.20175—
+5K163506Coalesce™ (-Straight, -Convex, -Crescent, -Lateral, -Anterior, or -Oblique) Lumbar…Vertera, Inc.2017224—
+5K162133VerteFIT Corpectomy Cage SystemLdr Spine USA, Inc.20170—
+5K162236Ax Stand-Alone ALIF SystemInnovasis, Inc.201774—
+5K170643Interbody Fusion (IBF)/Vertebral Body Replacement (VBR) SystemRti Surgical, Inc. Dba Rti Biologics201711—
+5K170055CAPRI Corpectomy Cage SystemK2m201711—
+5K170455MectaLIF Anterior Stand AloneMedacta International S.A.20174—
+5K162351SeaSpine® Vu a•POD™ Prime NanoMetalene® Intervertebral Body Fusion DeviceSeaSpine Orthopedics Corporation201679—
+5K162103Choice Spine Lumbar Spacer System (Sabre™, Shark™, Hornet™, Harpoon™), Choice Spine…Choicespine, LP2016161—
+5K160924Amendia Interbody Fusion DevicesAmendia, Inc.2016166—
+5K161173Avenue® T TLIF CageLdr Spine USA, Inc.20163—
+5K151481Sahara Stabilization SystemK2m, Inc.20155—
+5K151408LOSPA IS Spinal SystemCorentec Co., Ltd.20151—
+5K150673SYNFIX Evolution Secured Spacer SystemSynthes (USA) Products, LLC2015137—
+5K151056Aesculap T-Space PEEK and XP Spinal SystemAesculap Implant Systems, LLC20150—
+5K151184InFill Interbody Fusion DevicesPinnacle Spine Group, LLC20153—
+5K142005SpineFab Vertebral Body Replacement (VBR) SystemOxford Performance Materials201513—
+5K151214ALIF Interfixated SystemNu Vasive, Incorporated2015220—
+5K150643Centinel Spine STALIF TT, STALIF MIDLINE, MIDLINE II, MIDLINE II-TiCentinel Spine, Inc.2015368—
+5K150521Interbody Fusion (IBF)/Vertebral Body Replacement (VBR) SystemRti Surgical, Inc. Dba Rti Biologics201512—
+5K150206InFill Interbody Fusion DevicesPinnacle Spine Group, LLC20152—
+5K141135Juliet LLSpineart2014146—
+5K132907Plif Lite and Tlif LiteSintea Plustek20140—
+5K140142Choice Spine Lumbar Spacer System (Sabre, Shark, Hornet, Harpoon)Choicespine, LP2014172—
+5K133455Crossfuse II Coronal Taper, Crossfuse II HyperlordoticPioneer Surgical Technology, Inc.20145961
+5K133623C-PLUSPioneer Surgical Technology, Inc.2014598—
+5K123758Tasmin RSignus Medizintechnik GmbH20141—
+5K133207Staxx (R) SystemSpine Wave, Inc.20131—
+5K132718Integrity Spine Core SystemIntegrity Spine20131—
+5K130573Tyber Medical Interbody System; Acif, Alif, Plif, Tlif, DlifTyber Medical, LLC2013251—
+5K123206Maxim Surgical X-Treme Interbody Fusion SystemMaxim Surgical2013454—
+5K123388K7C SpacerK7, LLC20130—
+5K121581Box Peek VBR System,Innovasis, Inc.20121—
+5K121103LDR Spine Usa Spine Tune, TL Spinal System, LDR Spine Usa Easyspine, Posterior Spinal…Ldr Spine USA, Inc.201216—
+5K120345Honour Spacer SystemNexxt Spine, LLC2012212—
+5K112496Pioneer Crossfuse II Ibf/VBR SystemPioneer Surgical Technology, Inc.2011604—
+5K110659Medical Concepts Interbody Fusion SystemMedical Concepts, Inc.20111—
+5K110650Zyston Arc Interbody SpacerBiomet Spine (Aka Ebi, LLC)2011177—
+5K103034Genesys Spine Interbody Fusion SystemGenesys Spine20101371
+5K100042Difusion Technologies Xiphos Interbody Fusion SystemDifusion Technologies2010864—
+5K101288Staxx XD SystemSpine Wave, Inc.201051
+5K092540C-PS Peek Optima Cervical Interbody Spacer, L-PS Peek Optima Lumbar Interbody SpacerRsb Spine, LLC201045—
+5K092904Pathway Ivb/VBRCustom Spine, Inc.2009296—
+5K091088LDR Spine Cervical Interbody Fusion SystemLdr Spine USA2009901—
+5K083815Lanx Fusion SystemLanx, Inc.2009451—
+5K090064Eminent Spine Interbody Fusion SystemEminent Spine20097011
+5K083311Aesculap Cespace Peek Intervertebral Body Fusion SystemAesculap Implant Systems, Inc.2009554—
+5K083857LDR Spine Roi-C ImplantLdr Spine USA2009902—
+5K081880Atlas Spine SpacerAtlas Spine, Inc.20080—
+5K080971Spinesmith Cimplicity Spinal SystemSpine Smith Partners L.P.2008406—
+5K072326Ostapek VBR SystemCo-Ligne AG20081—
+5K080728LDR Spine Roi-C ImplantLdr Spine USA2008903—
+5K080569LDR Spine Roi-T ImplantLdr Spine USA20080—
+5K071983Aesculap Peek Intervertebral Body Fusion System: a Space, Cespace, Prospace, T-SpaceAesculap Implant Systems, Inc.20087881
+5K080572LDR Spine Roi-a ImplantLdr Spine USA2008113—
+5K071726ZUMASeaspine, Inc.200712—
+5K072132LDR Spine Roi-T SystemLdr Spine USA20071—
+5K071497Atlas Spine Vertebral Body ReplacementAtlas Spine, Inc.20070—
+5K062759Paramount VBR SystemInnovative Spinal Technologies, Inc.20071,406—
+5K061151Pioneer Vertebral Spacer (Vertebral Spacer)Pioneer Surgical Technology2006801—
+5K051454Aleutian Spacer SystemK2m, LLC2005666—
+5K051246Construx Mini Peek VBR SystemBlackstone Medical, Inc.2005834—
+6K263049SABER-C SystemElevation Spine20260—