510(k) Report

Devices descending from K082406

527 later devices reach Expandable Peek-Optima Implant through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K122989Biomet Lateral Spacer SystemBiomet Spine (Aka Ebi, LLC)2012171—
+1K120557Solitarie Peek Anterior Spinal System-to BE Called Colitaire 35Biomet Spine & Bone Healing Technologies20121—
+1K112014Zyston Straight Spacer SystemBiomet Spine2011174—
+1K110650Zyston Arc Interbody SpacerBiomet Spine (Aka Ebi, LLC)2011177—
+1K092574Esl Spinal SystemEbi, L.P.2010181—
+1K092336C-Thru Spinal SystemEbi, L.P.2009492—
+1K091381Ibex Spinal SystemEbi, L.P.2009181—
+2K233375Tranquil-L Interbody SystemNexus Spine, LLC20240—
+2K170119Calix Lumbar Spinal Implant SystemX-Spine Systems, Inc.201711
+2K170243LOSPA IS TLIF & DLIF CagesCorentec Co., Ltd.20170—
+2K151310Amendia Interbody Fusion DevicesAmendia, Inc.2016169—
+2K151064Solitaire-C Cervical Spacer System, C-Thru Anterior Spinal System, Breckenridge Small…Biomet Spine201517—
+2K132483Innesis Peek Cervical CageBk Meditech, Co., Ltd.20140—
+2K132926Velofixtm Interbody Fusion SystemU&I Corp.201410—
+2K130641Logic Stand-Alone Intervertebral Body Fusion DeviceBinder Biomedical, Inc.20130—
+2K122518Synster (Cervical,Alif, Plif, Ptlif and Tlif) Cage Hera Cervical Cage Rhea Plif Cage…Bm Korea Co., Ltd.20133—
+2K121320C7 Anterior Cervical Intervertebral Fusion CageMedyssey Co, Ltd.20122—
+2K113796Solitaire-C Cervical Spacer SystemEbi, LLC20121421
+2K111983Vista-S Device Model 08/06-401-Xxxxx, 08/06-402-XxxxxxZimmer Trabecular Metal Technology201131—
+2K100214Cornerstone PSR Cervical Interbody Fusion DeviceMedtronic Sofamor Danek2010389—
+3K252351UniSpace® TPLIF CageCg Medtech Co., Ltd.20250—
+3K211501Advantage-C PEEK Cervical lnterbody Fusion DeviceLntelivation, LLC20211—
+3K210044Crystal Spinal System & Vertu Spinal System, Lucent Spinal System, Zeus Spinal System…Spinal Elements, Inc.20211—
+3K203520Blustone Synergy Interbody Fusion SystemBlustone Synergy, LLC20210—
+3K192502Anatomic PEEK™ Cervical Fusion System, Anatomic PEEK™ PTC Cervical Fusion System…Medtronic Sofamor Danek USA, Inc.20204—
+3K192208CORNICE Cervical Spacer SystemLegend Spine Technologies20190—
+3K182920MiRus™ Lumbar Interbody Fusion System consisting of CALLISTO™ PEEK Posterior Lumbar…MiRus, LLC20199—
+3K172419Velofix™ TLIF CageU&I Corporation20172—
+3K163366Shanghai Sanyou CARMEN Cervical Fusion SystemShanghai Sanyou Medical Co, Ltd.20170—
+3K171075Calix-C Cervical Interbody SpacerX-Spine Systems, Inc.201715—
+3K171749Velofix (tm) Interbody Fusion SystemU&I Corporation20175—
+3K160924Amendia Interbody Fusion DevicesAmendia, Inc.2016166—
+3K152622Alta ACDF SystemBiomet Spine20160—
+3K152793Unison-C Anterior Cervical Fixation SystemPioneer Surgical Technology, Inc., Dba Rti Surgical, Inc.201629—
+3K143297Ardis Interbody System, BAK Interbody Fusion System, BAK/C Anterior Cervical Interbody…Zimmer Spine, Inc.201519—
+3K141599Divergence Anterior Cervical Fusion SystemMedtronic Sofamor Danek USA, Inc.201516—
+3K140864Veloxtm Interbody Fusion SystemU&I Corp.20149—
+3K133784Vista-S Device, Associated InstrumentationZimmer Trabecular Metal Technology201429—
+3K132584Perimeter C Spinal SystemMedtronic Sofamor Danek USA, Inc.2013119—
+3K132029Vault-C Intervertebral Body Fusion DeviceSpinal USA2013108—
+3K130853Idys (TM) CClariance20132—
+3K131429Reliance Cervical Ibf SystemReliance Medical Systems, LLC201324—
+3K122801Providence Cervical CageProvidence Medical Technology, Inc.20131—
+3K122037Anatomic Peek Cervical Fusion System Cornerstone PSR Cervical Fusion System Peek Prevail…Medtronic Sofamor Danek, Inc.2013281—
+3K120275Synthes Acis/Vertebral Spacer CRSynthes (Usa), LLC2012173—
+3K112444Anatomic Peek Cervical Fusion SystemMedtronic Sofamor Danck USA, Inc.2011324—
+3K110442Nanovis Intervertebral Body Fusion SystemNanovis, LLC201110—
+3K111264Cornerstone (R) PSR Cervical Fusion SystemMedtronic Sofamor Danek USA2011331—
+3K100967Perimeter C Spinal SystemMedtronic Sofamor Danek USA, Inc.2011121—
+4K242303MOD-COrthomod, LLC20260—
+4K252711Advantage-C™ Ti3D Cervical Interbody Fusion DeviceIntelivation Technologies20260—
+4K251431FIX-C PEEK ACIF SA SystemJeil Medical Corporation20250—
+4K241164IB3D™ PL Spinal SystemMedicrea International S.A.S. (Medtronic)202412
+4K240715Idys® C ZP 3DTiClariance20240—
+4K231739Cervical Spine Truss System (CSTS)4Web Medical, Inc.20232—
+4K230607SPICCA Cervical Fusion CagesSouthern Medical (Pty), Ltd.20230—
+4K230936Anatomic PEEK™ Cervical Fusion System with NanotechnologyNanovis, LLC20230—
+4K222004INTEGRATE -C Interbody Fusion SystemHappe Spine20236—
+4K202266Reliance Cervical IBF SystemReliance Medical Systems, LLC20223—
+4K211417F3D-C2 Cervical Stand-Alone SystemCorelink, LLC20223—
+4K212358Romero Cervical CageSpineup, Inc.20226—
+4K212266FIX-C PEEK Anterior Cervical Interbody SystemJeil Medical Corporation20217—
+4K212853Cervical Stand-Alone SystemEminent Spine, LLC202118—
+4K212562Idys-C ZP 3DTiClariance, SA20211—
+4K201793EDEN Peek CageJmt Co., Ltd.20210—
+4K202398Ti3Z Cervical Interbody SystemZavation Medical Products, LLC20219—
+4K203129NexGen Standalone Anterior Cervical Discectomy and Fusion (ACDF) SystemPrecision Spine, Inc.20210—
+4K200458Tailored-C Cervical Interbody Fusion SystemBespoke Technologies20203—
+4K202305Zavation IBF SystemZavation Medical Products, LLC20209—
+4K200087F3D Cervical Stand-Alone Interbody Fusion SystemCorelink, LLC202025—
+4K191906MiRus 3D Printed Lumbar Interbody Fusion Systems consisting of the Callisto 3D Printed…MiRus, LLC20206—
+4K191822Nano FortiCore, FortiCoreNanovis, LLC20192—
+4K190870Cervical Spinal Truss System-Stand Alone (CSTS-SA)4Web, Inc.201910—
+4K183243Velofix TLIF CageU&I Corporation20190—
+4K190618RIGEL PEEK Anterior Cervical Interbody Fusion SystemMiRus, LLC20191—
+4K190546NEXXT MATRIXX Stand Alone Cervical SystemNexxt Spine, LLC201993—
+4K183184FlareHawk Interbody Fusion SystemIntegrity Implants, Inc.201912—
+4K182885Atlantis™ Anterior Cervical Plate, Divergence™ Anterior Cervical Fusion System, Premier™…Medtronic Sofamor Danek USA, Inc.20198—
+4K190067Velofix Interbody Fusion SystemU&I Corporation20193—
+4K180822VariLift-LX Interbody Fusion System, VariLift-C Interbody Fusion SystemWenzel Spine, Inc.20195—
+4K181140Axis Chena Cervical PEEK Spacer SystemAxis Orthopaedics20182—
+4K181829Velofix TLIF CageU&I Corporation20181—
+4K181229TirboLOX-C Cervical IBFDCaptiva Spine, Inc.20180—
+4K180364HD LifeSciences Cervical IBFD SystemHd Lifesciences, LLC2018106—
+4K173832InTice™-C Porous Ti Cervical Interbody SystemX-Spine Systems, Inc.201801
+4K172568CervagePrecifit Medical, Ltd.20181—
+4K172320Neurostructures Cavetto® Cervical Cage SystemNeurostructures, Inc.20183—
+4K173102Reliance Cervical IBF SystemReliance Medical Systems, LLC201715—
+4K172185Tyber Medical PT Interbody Spacer SystemTyber Medical, LLC20177—
+4K172424Velofix™ SA Cervical CageU&I Corporation201751
+4K172392Lateral Spinal Truss System (LSTS) Interbody Fusion Device4Web, Inc.20171—
+4K172328SOVEREIGN™ Spinal SystemMedtronic Sofamor Danek USA, Inc.201730—
+4K171689ARTiC-L 3D Ti Spinal System with TiONIC Technology, ARTiC-XL 3D Ti Spinal System with…Medtronic Sofamor Danek USA, Inc.2017109—
+4K171107CAPSTONE CONTROL Spinal System, CAPSTONE CONTROL PTC Spinal SystemMedtronic Sofamor Danek USA, Inc.20178—
+4K171351Posterior Spine Truss System (PSTS) Interbody Fusion Device4Web, Inc.20177—
+4K171496Tritanium C Anterior Cervical CageStryker Spine2017129—
+4K170851Anterior Spine Truss System (STS) Interbody Fusion Device4Web, Inc.20175—
+4K170318NeoFuse Ti3D PLIF/TLIF/Cervical InterbodyHt Medical, LLC201749—
+4K170830Unison-C Anterior Cervical Fixation SystemPioneer Surgical Technology, Inc., Dba Rti Surgical, Inc.20175—
+4K162986SPIRA Open Matrix ALIFCamber Spine Technologies201711—