510(k) Report

Devices descending from K040928

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

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+5K171686Choice Spine Hawkeye™ Vertebral Body Replacement (VBR) SystemChoicespine2017116—
+5K171893Blustone Synergy Lumbar Interbody Fusion System (Basalt, Magma, Obsidian), Blustone…Bluestone Synergy20172—
+5K172489Reliance Cervical IBF SystemReliance Medical Systems, LLC201716—
+5K171329Altus Spine Titanium Interbody Fusion SystemAltus Partners, LLC20172—
+5K171140Matrixx SystemNexxt Spine, LLC2017145—
+5K170888Renovis S141 Lumbar Interbody Fusion SystemRenovis Surgical Technologies20175—
+5K171656Genesys Spine Apache Interbody Fusion SystemGenesys Spine20170—
+5K170676HD Lumbar Interbody SystemHd Lifesciences, LLC2017122—
+5K170399Endoskeleton TO Interbody Fusion Device (IBD)Titan Spine, LLC2017105—
+5K170844Gemini-C Hybrid Cervical Interbody SystemOsseus Fusion Systems, LLC20170—
+5K170297Tranquil Interbody SystemNexus Spine, LLC201715—
+5K162212Divergence-L Anterior/Oblique Lumbar Fusion SystemMedtronic Sofamor Danek USA, Inc.201757—
+5K171097MOJAVE Expandable Interbody SystemK2m, Inc.201717—
+5K170643Interbody Fusion (IBF)/Vertebral Body Replacement (VBR) SystemRti Surgical, Inc. Dba Rti Biologics201711—
+5K163581Navigated ELEVATE Inserter, Navigated Disc Prep InstrumentsMedtronic Sofamor Danek USA, Inc.2017103—
+5K163230NuVasive Modulus XLIF Interbody SystemNu Vasive, Incorporated2017276—
+5K160976Altus Spine Interbody Fusion SystemAltus Partners, LLC20178—
+5K162680SOVEREIGN® Spinal SystemMedtronic Sofamor Danek USA, Inc.201631—
+5K161809ShurFit CpTi-HA ACIF Interbody Fusion SystemPrecision Spine, Inc.20165—
+5K161993Leva® Anterior Interbody SystemSpine Wave, Inc.20160—
+5K160959Xsert Lumbar Expandable Interbody SystemX-Spine Systems, Inc.201612—
+5K161438Genesys Spine Apache® Anterior Lumbar Interbody Fusion SystemGenesys Spine201611—
+5K162264Cascadia Interbody SystemK2m, Inc.2016169—
+5K161888JULIET® LL Lateral Lumbar CageSpineart2016145—
+5K152099Genesys Spine Apache® Anchored Cervical Interbody Fusion SystemGenesys Spine201619—
+5K153621Juliet® TiSpineart2016751
+5K152501Spinal Jaxx Interbody Fusion DeviceNeuropro Spinaljaxx, Inc.201601
+5K160208NILE Alternative Fixation Spinal SystemK2m, Inc.20165—
+5K153695Biomet Spine Fusion SystemBiomet Spine, LLC201632
+5K151900VariLift-L Interbody Fusion DeviceWenzel Spine, Inc.20158—
+5K152277PIVOX (tm) Oblique Lateral Spinal SystemMedtronic Sofamor Danek USA, Inc.2015190—
+5K150321EVOS Lumbar Interbody SystemCutting Edge Spine, LLC201592—
+5K150500Px PEEK IBF SystemInnovasis, Inc.201558—
+5K150521Interbody Fusion (IBF)/Vertebral Body Replacement (VBR) SystemRti Surgical, Inc. Dba Rti Biologics201512—
+5K150152The Octane Straight Intervertebral Fusion Device, Ti CoatedExactech, Inc.201510—
+5K143258PLIF STS, TLIF STS, OLIF STS (Spinal Truss System)4Web, Inc.2015211—
+5K141798Sypher Spacer SystemBiogennix, LLC20151—
+5K142996StaXx (R) XD SystemSpine Wave, Inc.20150—
+5K143126Renovis S141 Lumbar Interbody Cage SystemRenovis Surgical Technologies2015237—
+5K142940Endoskeleton TCS SystemTitan Spine, LLC20151112
+5K133827A-Link ZOsteo Vasive, LLC2014262
+5K142101Abacus (TM) Spacer SystemSpine Wave, Inc.20140—
+5K142095Renovis S134 Anterior Lumbar Interbody Fusion (Alif) SystemRenovis Surgical Technologies, Inc.2014254—
+5K141791Biomet Fusion SystemBiomet Spine2014128—
+5K142450DIVERGENCE Anterior Cervical Fusion SystemMedtronic Sofamor Danek USA, Inc.20146—
+5K141443Infront Lumbar Interbody Fusion SystemInfront Medical, LLC20142—
+5K141129Exactech Cervical Spacer SystemExactech, Inc.20148—
+5K133053Milestone Spinal SystemWeigao Orthopaedic Device Co., Ltd.20142—
+5K133721Infill 41-Tlif Convex Oblique Device, Infill 43-Tlif Contour Oblique, Infill 44-Tlif…Pinnacle Spine Group, LLC20145—
+5K133455Crossfuse II Coronal Taper, Crossfuse II HyperlordoticPioneer Surgical Technology, Inc.20145961
+5K133623C-PLUSPioneer Surgical Technology, Inc.2014598—
+5K133650Capstone Spinal SystemMedtronic Sofamor Danek USA, Inc.2013344—
+5K132897Clydesdale Spinal SystemMedtronic Sofamor Danek, Inc.2013279—
+5K130274Biolign Acif Systems, Biolign Stacc Acif System, Biolign Tlif SystemElite Surgical Supplies (Pty), Ltd.20139—
+5K131296Varilift-L Interbody Fusion DeviceWenzel Spine, Inc.20130—
+5K131540Interfuse L Intervertebral Body Fusion DeviceVertebral Technologies, Inc.20136—
+5K131082Interform Interbody Cage SystemNext Orthosurgical2013595—
+5K131425Navigated Capstone Trials, Clydesdale Trials, Capstone & Clydesdale InserterMedtronic Navigation, Inc.201324610
+5K131547Lanx Fusion SystemLanx, Inc.20131631
+5K131671MectalifMedacta International201322—
+5K122588Vusion CS PlusOrtho Development Corp.2013206—
+5K130506Imse P-TlifInstitute of Musculoskeletal Science & Education20130—
+5K123978Capstone L Spinal SystemMedtronic Sofamor Danek USA201313—
+5K121254Camber Spine Technologies TLS 5.0 Inerbody CageCamber Spine Technologies201340—
+5K122956Fuselox Lumbar Interbody Fusion DeviceCaptiva Spine20122—
+5K122366Tryptik CC Anterior Intersomatic Cervical CageSpineart20125—
+5K122021Sterispine LC CageSafe Orthopaedics20122—
+5K122047Alamo PAlliance Partners, LLC20120—
+5K121760Capstone Spinal SystemMedtronic Sofamor Danek USA, Inc.2012723—
+5K121569Matisse Anterior Cervical Interbody Fusion Cage SystemAccel Spine20123—
+5K120840Lexus Cervical Intervertebral Body Fusion Cage SystemL&K BIOMED Co., Ltd.201214—
+5K120396Reliance Cervical Ibf SystemReliance Medical Systems, LLC201225—
+5K120368Capstone Control Spinal SystemMedtronic Sofamor Danek USA, Inc.2012761—
+5K120576Zavation Ibf SystemZavation, LLC201232—
+5K113478Plif CageEisertech, LLC2012269—
+5K113528Clydesdale (R) Spinal SystemMedtronic Sofamor Danek USA, Inc.2011361—
+5K112862Mecta-CMedacta International201114—
+5K110562Telamon Peek Spinal SystemMedtronic Sofamor Danek USA2011306—
+5K112496Pioneer Crossfuse II Ibf/VBR SystemPioneer Surgical Technology, Inc.2011604—
+5K110543Crescent (R) Spinal System TitaniumMedtronic Sofamor Danek USA, Inc.2011808—
+5K111569Plateau Spacer SystemLife Spine2011181—
+5K110927MectalifMedacta International2011301
+5K103111Forza Spacer SystemOrthofix, Inc.20113431
+5K100945Fuse Plif CafeAdvanced Medical Technologies AG2011463—
+5K100210TRANS1 Lateral Intervertebral Fusion Device, TTrans1 Incorporated2010175—
+5K100544Impix Lumbar Interbody DeviceMedicrea Technologies201001
+5K100175Clydesdale Spinal SystemMedtronic Sofamor Danek20101,008—
+5K094025Crescent Spinal SystemMedtronic Sofamor Danek2010838—
+5K092540C-PS Peek Optima Cervical Interbody Spacer, L-PS Peek Optima Lumbar Interbody SpacerRsb Spine, LLC201045—
+5K091813Intrepid Spinal SystemMedtronic Sofamor Danek2009719—
+5K090353Perimeter Interbody Fusion DeviceMedtronic Sofamor Danek2009796—
+5K082801Phantom Plus Cage SystemUs Spine2008643—
+5K082732Modification to: Capstone Spinal SystemMedtronic Sofamor Danek USA, Inc.2008710—
+5K082342Modification to Capstone Spinal SystemMedtronic Sofamor Danek2008716—
+5K081849Blackstone Pillar SA Partial Vertebral Body Replacement DeviceBlackstone Medical, Inc.20087531
+5K073109Stalif TT Intervertebral Body Fusion SystemSurgicraft, Ltd.2008907—
+6K262726NeckTune™ SA Cervical CageMedyssey Co., Ltd.20260—
+6K262595VariLift-C Cervical Interbody Fusion SystemWenzel Spine, Inc.20260—
+6K261882Pisces-SC Standalone Cervical Interbody SystemOsseus Fusions Systems, LLC20260—
+6K261353Tesera-K Anterior Lumbar Interbody Fusion (ALIF) System; Tesera-K XL System; Lumbar…Kyocera Medical Technologies, Inc.20260—