510(k) Report

Devices descending from K003155

2,091 later devices reach Vertebral Body Replacement through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+4K230708Peridot-TD Spacer system (The Peridot-TD Intervertebral body fusion system); Anterior…Gbs Commonwealth Co., Ltd.20233—
+4K221490Tritanium C Anterior Cervical Cage, Tritanium PL Cage, Tritanium TL Curved Posterior…Stryker Spine20231—
+4K223474PathLoc-TA Expandable Lumbar Cage SystemL&K BIOMED Co., Ltd.20231—
+4K223412LumiVy™ Lumbar IBF SystemVy Spine, LLC20235—
+4K222028IdentiTi™ Porous Ti Interbody System, IdentiTi™ NanoTec™ Interbody System, Transcend™…Alphatec Spine202228—
+4K220711SeaSpine Meridian System, SeaSpine Meridian Anterior Plate SystemSeaSpine Orthopedics Corporation202210—
+4K212126MediExpand Cervical Expandable VBR SystemCmf Medicon Surgical, Inc.20220—
+4K212498Stable-L Standalone Lumbar Interbody SystemNexus Spine, LLC20227—
+4K211320CAPRI Corpectomy Cage SystemK2m, Inc.20222—
+4K212904SeaSpine WaveForm C Interbody SystemSeaSpine Orthopedics Corporation202115—
+4K210583SeaSpine WaveForm™ A Interbody SystemSeaSpine Orthopedics Corporation202114—
+4K202637F3D Corpectomy SystemCorelink, LLC20201—
+4K200879SeaSpine Meridian System, SeaSpine Regatta Lateral SystemSeaSpine Orthopedics Corporation202060—
+4K193418SeaSpine Skipjack SystemSeaSpine Orthopedics Corporation20204—
+4K193412NEXXT MATRIXX SystemNexxt Spine, LLC20201—
+4K190284Bengal Stackable Cage SystemMedos International SARL20190—
+4K192132SeaSpine Beachside SystemSeaSpine Orthopedics Corporation2019591
+4K191066CD Horizon™ Astute™ Spinal SystemMedtronic Sofamor Danek USA, Inc.201921—
+4K191778Omnia Medical VBROmnia Medical, LLC20195—
+4K191621ChoiceSpine Octane A/T/P Spinal Implant System, ChoiceSpine Cervical Interbody Spacer…Choice Spine, LLC20194—
+4K182928CD Horizon™ Spinal SystemMedtronic Sofamor Danek USA, Inc.201953—
+4K180550NuVasive Monolith Cervical Corpectomy SystemNu Vasive, Incorporated201811—
+4K181818Scarlet AL-TSpineart201864—
+4K181079SeaSpine Regatta Lateral SystemSeaSpine Orthopedics Corporation201863—
+4K171848FORTIFY and FORTIFY Integrated Corpectomy Spacers, XPand Corpectomy Spacers, NIKO…Globus Medical, Inc.201755—
+4K162315FORTIFY Corpectomy SpacersGlobus Medical, Inc.201755—
+4K173022SeaSpine Ventura NanoMetalene SystemSeaSpine Orthopedics Corporation20170—
+4K171046SeaSpine Cambria SystemSeaSpine Orthopedics Corporation201762—
+4K152022SUSTAIN® R Spacers, PATRIOT® Spacers, CALIBER® Spacers, RISE® Spacers, COALITION®…Globus Medical, Inc.2017149—
+4K162351SeaSpine® Vu a•POD™ Prime NanoMetalene® Intervertebral Body Fusion DeviceSeaSpine Orthopedics Corporation201679—
+4K162715SeaSpine Spacer System- Hollywood NanoMetalene, Hollywood VI NanoMetalene, Ventura…SeaSpine Orthopedics Corporation2016103—
+4K153665Prow Fusion-LNlt Spine, Ltd.20160—
+4K160605MectaLIF Anterior Stand-AloneMedacta International201610—
+4K153720ENZA Zero-Profile Anterior Interbody FusionCamber Spine Technologies20164—
+4K153413PASS LP Spinal SystemMedicrea International SA20160—
+4K143578SUSTAIN R TPS Spacers, PATRIOT TPS Spacers, CALIBER TPS Spacer, COALITION TPS Spacers…Globus Medical, Inc.2016210—
+4K152568C-VBRCardinal Spine, LLC201657—
+4K141942Midline II TICentinel Spine, Inc.2014459—
+4K133340Spineworks Anterior Lumbar DeviceSpineworks, LLC201413—
+4K133286Midline (TM)Centinel Spine, Inc.2014460—
+4K130254Prow FusionNlt Spine, Ltd.20138—
+4K130461Stalif XCentinel Spine, Inc.201313—
+4K131082Interform Interbody Cage SystemNext Orthosurgical2013595—
+4K130820Expandable Lumbar Interbody SystemNu Vasive, Incorporated2013593—
+4K124034Mectalif AnteriorMedacta International201311—
+4K121211VU Apod Intervertebral Body Fusion DeviceTheken Spine, LLC2012129—
+4K110562Telamon Peek Spinal SystemMedtronic Sofamor Danek USA2011306—
+4K094025Crescent Spinal SystemMedtronic Sofamor Danek2010838—
+4K090353Perimeter Interbody Fusion DeviceMedtronic Sofamor Danek2009796—
+4K091974Modification to CD Horizon Spinal SystemMedtronic Sofamor Danek USA, Inc.20096561
+4K082236CD Horizon Spinal SystemMedtronic Sofamor Danek2008779—
+4K081564Creaspine Supstance Vertebral Body Replacement System Line ExtensionCreaspine20080—
+4K073562Modification to Viper Spine SystemDepuy Spine, Inc.2008213—
+4K063670Modifications to CD Horizon Spinal SystemMedtronic Sofamor Danek2007821—
+4K060762Aesculap Peek Vertebral Body Replacement SystemAesculap, Inc.2006789—
+4K061752Spinal Usa VBR SystemSpinal USA20060—
+4K061938Verte-Stack Spinal SystemMedtronic Sofamor Danek, Inc.2006152—
+4K061915CD Horizon Spinal SystemMedtronic Sofamor Danek200654—
+4K060719Modification to Verte-Stack Spinal SystemMedtronic Sofamor Danek2006992—
+4K052170Seaspine VBR SystemSeaspine, Inc.200513—
+4K052931Modification to Verte-Stack Spinal SystemMedtronic Sofamor Danek2005993—
+4K052747Modification to:CD Horizon Spinal SystemMedtronic Sofamor Danek2005528—
+4K052609Modification to CD Horizon Spinal SystemMedtronic Sofamor Danek200554—
+4K052187Modification to: CD Horizon Spinal SystemMedtronic Sofamor Danek2005780—
+4K051674CD Horizon Spinal SystemMedtronic Sofamor Danek USA, Inc.2005587—
+4K043479MC+ Partial VBRLdr Spine USA20051,214—
+4K050348CO Vertebral Body ReplacementScient'X20052—
+4K050624Stryker Spine Avs PL Peek SpacerStryker Spine2005892—
+4K042571Stryker Spine Avs TL Peek SpacerStryker Spine2005894—
+4K043566Modification to Verte-Stack Spinal SystemMedtronic Sofamor Danek2005726—
+4K042713Fidji-Vertebral Body Replacement Type 5Spine Next America Corporation20040—
+4K042714Fidji-Vertebral Body Replacement Type 1, 2, 3 and 4Spine Next America Corporation2004838—
+4K041197Modification to Verte-Stack Spinal SystemMedtronic Sofamor Danek2004994—
+4K040731Stryker Spine Vertebral SpacerStryker Spine2004895—
+4K033926Hourglass Vertebral Body SpacerMedtronic Sofamor Danek2004763—
+4K041556Modification to Verte-Stack Spinal SystemMedtronic Sofamor Danek20041,002—
+4K040536Modification to Verte-Stack Spinal SystemMedtronic Sofamor Danek20041,150—
+4K040422Modification to Verte-StackMedtronic Sofamor Danek20041,002—
+5K261451ZSAlign Cervical Interbody SystemZSFab, Inc.20260—
+5K261810Vertiwedge® Intraosseous SystemFoundation Surgical Group20260—
+5K262061Tritanium® C Anterior Cervical Cage; Tritanium® PL Cage; Tritanium® TL Curved Posterior…Stryker Spine20260—
+5K252982CONDUIT™ ZERO-P™ VA Secured Spacer SystemAvalign Technologies, Inc.20260—
+5K260850Osteomni Spinal Cages SystemOsteomni, Inc.20260—
+5K254202MectaLIF 3D Metal AnteriorMedacta International S.A.20260—
+5K252219Cervical Interbody and VBR Fusion SystemSync Surgical20260—
+5K253158VyBrate™ VBR SystemVy Spine, LLC20260—
+5K253577IB3D™ PL Spinal System (A24000000 / IB3D Universal Implant Inserter)Medicrea International S.A.S. (Medtronic)20250—
+5K250987aprevo® posterior/transforaminal lumbar interbody fusion deviceCarlsmed, Inc.20251—
+5K251617X-PAC® TLIF Expandable Posterior Cage System; X-PAC® LLIF Expandable Lateral Cage SystemExpanding Innovations, Inc.20250—
+5K250602X-PAC® N-GAGE™ Lumbar Plate SystemExpanding Innovations, Inc.20250—
+5K250603AxTiHA® Stand-Alone ALIF SystemInnovasis20250—
+5K241375IdentiTi Porous Ti Interbody System; IdentiTi NanoTec Interbody System; IdentiTi…Alphatec Spine20253—
+5K243635aprevo® anterior lumbar interbody fusion device with interfixationCarlsmed, Inc.20245—
+5K242517ProAM ACDF SystemPro Surgical, Inc.20240—
+5K243106CarboClear® Hybrid Pedicle Screw SystemCarboFix Orthopedics, Ltd.20240—
+5K241992Catalyft™ LS Expandable Interbody SystemMedtronic Sofamor Danek USA, Inc.20240—
+5K242589Scarlet® AL-TSpineart SA20240—
+5K242829BluEX Lumbar Expandable Cage SystemL&K BIOMED Co., Ltd.20240—
+5K242364IdentiTi™ II Interbody SystemAlphatec Spine, Inc.20244—
+5K233807LumiVy™ Lumbar IBF SystemVy Spine, LLC20241—