510(k) Report

Devices descending from K040928

1,504 later devices reach Expandable Peek VBR Implant through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K122989Biomet Lateral Spacer SystemBiomet Spine (Aka Ebi, LLC)2012171—
+1K111294Santorini Spinal SystemK2m, Inc.201218—
+1K112014Zyston Straight Spacer SystemBiomet Spine2011174—
+1K092574Esl Spinal SystemEbi, L.P.2010181—
+1K092336C-Thru Spinal SystemEbi, L.P.2009492—
+1K091381Ibex Spinal SystemEbi, L.P.2009181—
+1K081636Peek-Optima Alif SpacerBiomet Spine2008542—
+1K052384Lanx VBR SystemLanx, LLC2005455—
+1K050861Peek CasInterpore Cross Intl.2005224—
+1K042930Spacevision Cage SystemSpine Vision, Inc.20041,440—
+2K233375Tranquil-L Interbody SystemNexus Spine, LLC20240—
+2K170389TAURUS PEEK Cage SystemMedyssey USA, Inc.20170—
+2K170119Calix Lumbar Spinal Implant SystemX-Spine Systems, Inc.201711
+2K171704CAPRI Corpectomy Cage SystemK2m201710—
+2K162133VerteFIT Corpectomy Cage SystemLdr Spine USA, Inc.20170—
+2K170055CAPRI Corpectomy Cage SystemK2m201711—
+2K151310Amendia Interbody Fusion DevicesAmendia, Inc.2016169—
+2K151481Sahara Stabilization SystemK2m, Inc.20155—
+2K151064Solitaire-C Cervical Spacer System, C-Thru Anterior Spinal System, Breckenridge Small…Biomet Spine201517—
+2K142016CAPRIK2m, Inc.201412—
+2K132483Innesis Peek Cervical CageBk Meditech, Co., Ltd.20140—
+2K132926Velofixtm Interbody Fusion SystemU&I Corp.201410—
+2K122639Synthes Syncage Evolution SpacerSynthes (USA) Products, LLC2013143—
+2K121320C7 Anterior Cervical Intervertebral Fusion CageMedyssey Co, Ltd.20122—
+2K120203TM-400 DeviceZimmer Trabecular Metal Technology, Inc.201220—
+2K113796Solitaire-C Cervical Spacer SystemEbi, LLC20121421
+2K111983Vista-S Device Model 08/06-401-Xxxxx, 08/06-402-XxxxxxZimmer Trabecular Metal Technology201131—
+2K110650Zyston Arc Interbody SpacerBiomet Spine (Aka Ebi, LLC)2011177—
+2K100214Cornerstone PSR Cervical Interbody Fusion DeviceMedtronic Sofamor Danek2010389—
+2K083815Lanx Fusion SystemLanx, Inc.2009451—
+2K082406Expandable Peek-Optima ImplantEbi, L.P.2009527—
+2K072326Ostapek VBR SystemCo-Ligne AG20081—
+2K070218Vertiflex Octane Peek Vertebral Body Replacement (Peek VBR)Vertiflex (Tm), Incorporated200760—
+2K062759Paramount VBR SystemInnovative Spinal Technologies, Inc.20071,406—
+2K061752Spinal Usa VBR SystemSpinal USA20060—
+2K051454Aleutian Spacer SystemK2m, LLC2005666—
+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—
+3K202820Australis Anterior Lumbar Cage SystemPrism Surgical Designs Pty, Ltd.20200—
+3K201585Monterey AL Interbody SystemStryker Corporation202044
+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—
+3K181899Roccia® PlifSilony Medical GmbH20180—
+3K180665SANTORINI Corpectomy Cage System, CAPRI Corpectomy Cage SystemK2m, LLC20189—
+3K181702Tranquil-L Interbody SystemNexus Spine, LLC20188—
+3K173893TrabisColigne AG20180—
+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—
+3K170243LOSPA IS TLIF & DLIF CagesCorentec Co., Ltd.20170—
+3K160924Amendia Interbody Fusion DevicesAmendia, Inc.2016166—
+3K152622Alta ACDF SystemBiomet Spine20160—
+3K152793Unison-C Anterior Cervical Fixation SystemPioneer Surgical Technology, Inc., Dba Rti Surgical, Inc.201629—
+3K151408LOSPA IS Spinal SystemCorentec Co., Ltd.20151—
+3K150673SYNFIX Evolution Secured Spacer SystemSynthes (USA) Products, LLC2015137—
+3K142634Biomet Spine Fusion SystemBiomet Spine, LLC20155—
+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—
+3K140142Choice Spine Lumbar Spacer System (Sabre, Shark, Hornet, Harpoon)Choicespine, LP2014172—
+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—
+3K131122S128 Anterior Lumbar Interbody Fusion (Alif) SystemRenovis Surgical Technologies, LLC2013269—
+3K122801Providence Cervical CageProvidence Medical Technology, Inc.20131—
+3K122037Anatomic Peek Cervical Fusion System Cornerstone PSR Cervical Fusion System Peek Prevail…Medtronic Sofamor Danek, Inc.2013281—
+3K122518Synster (Cervical,Alif, Plif, Ptlif and Tlif) Cage Hera Cervical Cage Rhea Plif Cage…Bm Korea Co., Ltd.20133—
+3K120275Synthes Acis/Vertebral Spacer CRSynthes (Usa), LLC2012173—
+3K120557Solitarie Peek Anterior Spinal System-to BE Called Colitaire 35Biomet Spine & Bone Healing Technologies20121—
+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—
+3K111439Chesapeake (Cervical Components)K2m, Inc.20113451
+3K102315Staxx XDL SystemSpine Wave, Inc.20113—
+3K100967Perimeter C Spinal SystemMedtronic Sofamor Danek USA, Inc.2011121—
+3K110843Aleutian Spacer SystemK2m, Inc.2011589—
+3K103666Lanx LateralLanx, Inc.2011238—
+3K103660Lanx Cervical Intervertebral Body Fusion SystemLanx, Inc.201141—
+3K102738Lanx Fusion SystemLanx, LLC20113281
+3K092211Chesapeake Spinal SystemK2m, Inc.2010450—
+3K092774Atlas Intervertebral Body CageSpinal Edge, LLC20100—
+3K082698Aleutian Ibf SystemK2m, Inc.2009662—
+3K082270Octane Vertebral Body Replacement (VBR) SystemVertiflex, Inc.200855—
+3K081383Reliance VBS SystemReliance Medical Systems, LLC20080—
+3K072120Paramount Intervertebral Body Fusion DeviceInnovative Spinal Technologies, Inc.20071,405—
+3K063637Reliance VBS SystemReliance Medical Systems, LLC20071—
+3K063399Aleutian Spacer SystemK2m, Inc.2007663—
+4K242303MOD-COrthomod, LLC20260—
+4K252711Advantage-C™ Ti3D Cervical Interbody Fusion DeviceIntelivation Technologies20260—
+4K250072CONDUIT™ SYNFIX™ Evolution Secured Spacer SystemAvalign Technologies, Inc.20251—
+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—