510(k) Report

Devices descending from K043206

1,571 later devices reach Pioneer Vertebral Body Replacement Device (Pioneer Vertebral Spacer) through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+4K151481Sahara Stabilization SystemK2m, Inc.20155—
+4K152515TOMCAT Cervical Spinal SystemChoicespine, LP2015108—
+4K153122Endoskeleton (r) TCS SystemTitan Spine, LLC20151061
+4K151900VariLift-L Interbody Fusion DeviceWenzel Spine, Inc.20158—
+4K151934ROI-C Titanium-Coated Implant SystemLdr Spine USA20159—
+4K151785Px HA PEEK IBF SystemInnovasis, Inc.201557—
+4K151596Endoskeleton TCS Interbody Fusion DeviceTitan Spine, LLC20151101
+4K151408LOSPA IS Spinal SystemCorentec Co., Ltd.20151—
+4K143479Bluefin Interbody SystemTides Medical20152—
+4K150765LDR Spine ROI-C Cervical Cage SystemLdr Spine USA201559—
+4K151727Everest Spinal SystemK2m, Inc.201511—
+4K150481Cascadia Interbody SystemK2m, Inc.20154593
+4K151064Solitaire-C Cervical Spacer System, C-Thru Anterior Spinal System, Breckenridge Small…Biomet Spine201517—
+4K151198A-CIFT SoloFuseSpinefrontier, Inc.20158—
+4K151184InFill Interbody Fusion DevicesPinnacle Spine Group, LLC20153—
+4K150321EVOS Lumbar Interbody SystemCutting Edge Spine, LLC201592—
+4K150362NuVasive CoRoent Small Interbody SystemNu Vasive, Incorporated2015441—
+4K142559ELEVATE Spinal SystemMedtronic Sofamor Danek USA, Inc.2015130—
+4K142269Reliance Cervical IBF SystemReliance Medical Systems, LLC201523—
+4K150130Ascendant TM Cervical Spacer SystemExactech, Inc.20157—
+4K142744Mecta-C TiPEEKMedacta International201512—
+4K150913Incite Anchored Cervical Interbody DeviceIncite Innovation20150—
+4K142392Zavation Posterior LEIFZavation, LLC20150—
+4K143258PLIF STS, TLIF STS, OLIF STS (Spinal Truss System)4Web, Inc.2015211—
+4K143360LnK Cervical Interbody Fusion Cage SystemL&K BIOMED Co., Ltd.20159—
+4K142218Coalition AGX Plate and Coalition AGX SpacerGlobus Medical, Inc.2015155—
+4K143214SCARLET® AC-T Secured Anterior Cervical CageSpineart20153—
+4K141599Divergence Anterior Cervical Fusion SystemMedtronic Sofamor Danek USA, Inc.201516—
+4K142360Everest Spinal SystemK2m, Inc.201522—
+4K143334Range/Denali/Mesa Spinal SystemK2m, Inc.201516—
+4K142152Construx Mini Peek; Spacer System, TI Spacer System, Cervical Stand Alone SystemOrthofix, Inc.2015280—
+4K142271Zavation Z-Link LumbarZavation, LLC20149—
+4K141537IN:C2 Spinal Fixation SystmeSpine Smith Holdings, LLC20140—
+4K142050Nuvasive Coroent Small Contoured Interbody SystemNu Vasive, Incorporated2014449—
+4K141314Scarlet AC-T Secured Anterior Cervical Cage and Associated InstrumentationSpineart201438—
+4K133717Longbow Spacer SystemLife Spine20149—
+4K141405Mobis II ST Spinal ImplantSignus Medizintechnik GmbH2014461—
+4K141873Range/Mesa/Denali Spinal SystemK2m, Inc.201430—
+4K140280ForticoreNanovis, LLC20149—
+4K141443Infront Lumbar Interbody Fusion SystemInfront Medical, LLC20142—
+4K140921Coroent Small Interbody SystemNu Vasive, Incorporated2014444—
+4K133053Milestone Spinal SystemWeigao Orthopaedic Device Co., Ltd.20142—
+4K140765Range/Mesa/Denali Spinal SystemK2m, Inc.201415—
+4K133494Chesapeake Spinal SystemK2m, Inc.2014330—
+4K141147Range Spinal SystemK2m, Inc.20141—
+4K140709Skyhawk Interbody Fusion SystemOrthofix, Inc.20147—
+4K140303Alamo TAlliance Partners, LLC20140—
+4K133340Spineworks Anterior Lumbar DeviceSpineworks, LLC201413—
+4K133614Aleutian Ibf SystemK2m, Inc.2014527—
+4K133205Capstone PTC Spinal System, Clydesdale PTC Spinal SystemMedtronic Sofamor Danek USA, Inc.2014124—
+4K132991C-Box Peek Cervical IbfInnovasis, Inc.20149—
+4K132582Exactech Acapella One Cervical Spacer SystemExactech, Inc.2014471
+4K133645Perimeter C Spinal System, Capstone Spinal System, Capstone L Spinal System, Perimeter…Medtronic Sofamor Danek USA, Inc.20146—
+4K133650Capstone Spinal SystemMedtronic Sofamor Danek USA, Inc.2013344—
+4K132897Clydesdale Spinal SystemMedtronic Sofamor Danek, Inc.2013279—
+4K132584Perimeter C Spinal SystemMedtronic Sofamor Danek USA, Inc.2013119—
+4K130853Idys (TM) CClariance20132—
+4K130274Biolign Acif Systems, Biolign Stacc Acif System, Biolign Tlif SystemElite Surgical Supplies (Pty), Ltd.20139—
+4K131350Calix Lumbar Spinal Implant SystemX-Spine Systems, Inc.2013214
+4K131429Reliance Cervical Ibf SystemReliance Medical Systems, LLC201324—
+4K131296Varilift-L Interbody Fusion DeviceWenzel Spine, Inc.20130—
+4K131425Navigated Capstone Trials, Clydesdale Trials, Capstone & Clydesdale InserterMedtronic Navigation, Inc.201324610
+4K130948C-Fuse Cervical Intervertebral Body Fusion SystemSouthern Spine, LLC201313—
+4K131671MectalifMedacta International201322—
+4K122801Providence Cervical CageProvidence Medical Technology, Inc.20131—
+4K130506Imse P-TlifInstitute of Musculoskeletal Science & Education20130—
+4K130306Incite Anchored Cervical Interbody DeviceIncite Innovation, LLC20131—
+4K123978Capstone L Spinal SystemMedtronic Sofamor Danek USA201313—
+4K123997TRANS1LATERAL Interbody Fusion SystemTrans1, Inc.2013173—
+4K122037Anatomic Peek Cervical Fusion System Cornerstone PSR Cervical Fusion System Peek Prevail…Medtronic Sofamor Danek, Inc.2013281—
+4K123993Solus Anterior Lumbar Interbody Fusion (Alif) SystemAlphatec Spine, Inc.20130—
+4K122872Intervertebral Body Fusion DeviceDio Medical Co., Ltd.201316—
+4K123134Easyspine SystemLdr Spine USA, Inc.20131—
+4K120603Varilift -CWenzel Spine2013193—
+4K121254Camber Spine Technologies TLS 5.0 Inerbody CageCamber Spine Technologies201340—
+4K121649Construx Mini Peek TI Spacer SystemOrthofix2012289—
+4K121151Pro-Link Cervical Spacer SystemLife Spine, Inc.2012116—
+4K122956Fuselox Lumbar Interbody Fusion DeviceCaptiva Spine20122—
+4K122021Sterispine LC CageSafe Orthopaedics20122—
+4K122047Alamo PAlliance Partners, LLC20120—
+4K120819Stalif CCentinel Spine, Inc.2012206—
+4K121760Capstone Spinal SystemMedtronic Sofamor Danek USA, Inc.2012723—
+4K120275Synthes Acis/Vertebral Spacer CRSynthes (Usa), LLC2012173—
+4K113796Solitaire-C Cervical Spacer SystemEbi, LLC20121421
+4K120368Capstone Control Spinal SystemMedtronic Sofamor Danek USA, Inc.2012761—
+4K113478Plif CageEisertech, LLC2012269—
+4K113528Clydesdale (R) Spinal SystemMedtronic Sofamor Danek USA, Inc.2011361—
+4K112444Anatomic Peek Cervical Fusion SystemMedtronic Sofamor Danck USA, Inc.2011324—
+4K110562Telamon Peek Spinal SystemMedtronic Sofamor Danek USA2011306—
+4K111264Cornerstone (R) PSR Cervical Fusion SystemMedtronic Sofamor Danek USA2011331—
+4K111439Chesapeake (Cervical Components)K2m, Inc.20113451
+4K110543Crescent (R) Spinal System TitaniumMedtronic Sofamor Danek USA, Inc.2011808—
+4K100967Perimeter C Spinal SystemMedtronic Sofamor Danek USA, Inc.2011121—
+4K111675VU C*Pod Intervertebral Body Fusion DeviceTheken Spine, LLC201162—
+4K111569Plateau Spacer SystemLife Spine2011181—
+4K110650Zyston Arc Interbody SpacerBiomet Spine (Aka Ebi, LLC)2011177—
+4K110927MectalifMedacta International2011301
+4K100945Fuse Plif CafeAdvanced Medical Technologies AG2011463—
+4K100175Clydesdale Spinal SystemMedtronic Sofamor Danek20101,008—
+4K094025Crescent Spinal SystemMedtronic Sofamor Danek2010838—