510(k) Report

Devices descending from K050553

381 later devices reach Novel VBR Spinal System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K232173Ascend VBR System, Ascend NanoTec VBR SystemAlphatec Spine, Inc.20230—
+1K151538NuVasive PEEK Corpectomy Railed SystemNu Vasive, Incorporated201513—
+1K151167NuVasive PEEK Corpectomy SystemNu Vasive, Incorporated201513—
+1K120570Choice Spine Vertebral Body Replacement (VBR) Device SystemChoicespine, LP2012322—
+1K103320Synthes XRLSynthes Spine Co.Lp201131
+1K063464Atlas Spine Vertebral Body ReplacementAtlas Spine, Inc.20072—
+1K062151Box Peek VBR SystemInnovasis, Inc.2006175—
+1K052170Seaspine VBR SystemSeaspine, Inc.200513—
+2K200235KONG-TL VBR System, KONG-C VBR SystemIcotec AG20201—
+2K171686Choice Spine Hawkeye™ Vertebral Body Replacement (VBR) SystemChoicespine2017116—
+2K170271NuVasive (r) Monolith Corpectomy SystemNu Vasive, Incorporated201712—
+2K152460Rectangular Corpectomy CageAmendia, Inc.20150—
+2K142005SpineFab Vertebral Body Replacement (VBR) SystemOxford Performance Materials201513—
+2K140142Choice Spine Lumbar Spacer System (Sabre, Shark, Hornet, Harpoon)Choicespine, LP2014172—
+2K130573Tyber Medical Interbody System; Acif, Alif, Plif, Tlif, DlifTyber Medical, LLC2013251—
+2K121581Box Peek VBR System,Innovasis, Inc.20121—
+2K081880Atlas Spine SpacerAtlas Spine, Inc.20080—
+2K071726ZUMASeaspine, Inc.200712—
+2K071497Atlas Spine Vertebral Body ReplacementAtlas Spine, Inc.20070—
+3K253158VyBrate™ VBR SystemVy Spine, LLC20260—
+3K232790KONG®-TL VBR System and KONG® C VBR SystemIcotec AG20240—
+3K211449Triton™ Sacroiliac Joint Fixation SystemChoice Spine, LLC20211—
+3K201367FlareHawk TiHawk9 Interbody Fusion SystemIntegrity Implants, Inc.20202—
+3K193457AUDERE Lumbar Spacer SystemMet One Technologies20201—
+3K190684LxHA PEEK Lateral IBF SystemInnovasis, Inc.20190—
+3K183092Kuros TLIF CageKuros Biosciences B.V20190—
+3K183588Choice Spine Hawkeye Vertebral Body Replacement (VBR) SystemChoicespine20195—
+3K183557Endoskeleton® TA Interbody Fusion Device, Endoskeleton® TAS Interbody Fusion Device…Titan Spine, Inc.20191043
+3K182284Tyber Medical PT Interbody SpacerTyber Medical, LLC20195—
+3K181589Curiteva Lumbar Interbody Fusion SystemCuriteva, LLC20186—
+3K180550NuVasive Monolith Cervical Corpectomy SystemNu Vasive, Incorporated201811—
+3K181921Solidity Vertebral Body ReplacementUlrich Medical USA20182—
+3K172185Tyber Medical PT Interbody Spacer SystemTyber Medical, LLC20177—
+3K163673Fortilink™-C with TETRAfuse™ 3D TechnologyRti Surgical, Inc.201711—
+3K162693VertebraLINK Fusion PlatformFacetlink Dba Linkspine20170—
+3K162103Choice Spine Lumbar Spacer System (Sabre™, Shark™, Hornet™, Harpoon™), Choice Spine…Choicespine, LP2016161—
+3K160699VIRTU Lumbar Spacer SystemMet 1 Technologies, LLC20162—
+3K153107Choice Spine Lumbar Spacer System (Sabre™, Shark™, Hornet™, Harpoon™), Choice Spine VEO™…Choicespine, LP2016171—
+3K150847Foundation Interbody DevicesCorelink, LLC201529—
+3K141333Arena-C Tifuse Cervical Intervertebral Body Fusion DeviceSpinefrontier, Inc.20140—
+3K133967Interbody Cage SystemAurora Spine2014227—
+3K124034Mectalif AnteriorMedacta International201311—
+4K254202MectaLIF 3D Metal AnteriorMedacta International S.A.20260—
+4K250605EVOL® ha – Hyper C Cervical Interbody Fusion SystemCutting Edge Spine, LLC20250—
+4K233509Zavation IBF System, Zavation Varisync Plate System and Varisync Spacer System…Zavation Medical Products, LLC20241—
+4K233744Curiteva Porous PEEK Lumbar Interbody Fusion SystemCuriteva, Inc.20242—
+4K231743F3D Lateral Lumbar Interbody System, CL5 Lateral Lumbar Interbody System, and Oro…Corelink, LLC20233—
+4K230639Align Cervical Interbody Fusion SystemAcuity Surgical Devices, LLC20232—
+4K231836ClariVy™ Cervical IBF SystemVy Spine, LLC20232—
+4K222874CarboClear Cervical Cage System, CarboClear Cervical VBR SystemCarbofix Orthpedics, Ltd.20230—
+4K231241NanoHive Medical Lumbar Interbody SystemNanoHive Medical, LLC20230—
+4K230851Kodiak Lumbar Spacer SystemMet One Technologies, LLC20230—
+4K230026SqualeImplanet, S.A.20230—
+4K230583Tryptik TiSpineart SA20231—
+4K223043The Integrity Spine Core SystemIntegrity Spine20230—
+4K221545MectaLIF Anterior ExtensionMedacta International S.A.202226
+4K211785CASSATT™ SIJ Fixation SystemCtl Medical Corporation20220—
+4K221535Align Lumbar Interbody Fusion SystemAcuity Surgical Devices, LLC20223—
+4K213493Fortilink with TiPlus TechnologyParadigm Spine20220—
+4K212075ShurFit Lumbar Interbody SystemPrecision Spine, Inc.20211—
+4K202637F3D Corpectomy SystemCorelink, LLC20201—
+4K192145Galileo Vertebral Body Replacement DeviceBright Spine20201—
+4K192897icotec Cervical CageIcotec AG20201—
+4K200048MectaLIF Anterior SimpleMedacta International S.A.20200—
+4K192906Mecta-C Stand AloneMedacta International S.A.20201—
+4K192718Fortilink Interbody Fusion Device (IBF) with TETRAfuse 3D TechnologyPioneer Surgical Technology, Inc., Dba Rti Surgical, Inc.20195—
+4K190426ALTA Anterior Cervical Corpectomy SystemAstura Medical, LLC20193—
+4K192054Endoskeleton TAS PlateTitan Spine, Inc.20190—
+4K191778Omnia Medical VBROmnia Medical, LLC20195—
+4K192018Endoskeleton TA Interbody Fusion Device, Endoskeleton TAS and TAS Hyperlordotic…Titan Spine, Inc.20191024
+4K191565Endoskeleton TCS Interbody Fusion DeviceTitan Spine, Inc.201901
+4K183239CoreLink F3D™ Lateral SystemCorelink, LLC20188—
+4K180814CoreLink® M3™ Stand-Alone Anterior Lumbar SystemCorelink, LLC201818—
+4K180556Corelink Foundation 3D Anterior Lumbar SystemCorelink, LLC20185—
+4K180590Tyber Medical PT Interbody Spacer SystemTyber Medical, LLC20186—
+4K173082Arco™-SA Lumbar Cage SystemNeurostructures, Inc.20185—
+4K172816TiGer Shark™ SystemChoicespine, LP201859—
+4K172064Ti-Diagon Oblique TLIFCamber Spine Technologies201727—
+4K171657ShurFit 2C Lumbar Interbody Fusion SystemPrecision Spine, Inc.20174—
+4K160976Altus Spine Interbody Fusion SystemAltus Partners, LLC20178—
+4K160605MectaLIF Anterior Stand-AloneMedacta International201610—
+4K143578SUSTAIN R TPS Spacers, PATRIOT TPS Spacers, CALIBER TPS Spacer, COALITION TPS Spacers…Globus Medical, Inc.2016210—
+5K252205Curiteva Porous PEEK Cervical Interbody System; Curiteva Porous PEEK Lumbar Interbody…Curiteva, Inc.20260—
+5K252219Cervical Interbody and VBR Fusion SystemSync Surgical20260—
+5K252610ZSFab Lumbar Interbody SystemZsfab, Inc.20251—
+5K250769Dakota LP SystemPrecision Spine, Inc.20250—
+5K251735Stabilis SA Cervical Stand-Alone System (Various PNs)Acuity Surgical Devices, LLC20251—
+5K250845Curiteva Porous PEEK Standalone ALIF SystemCuriteva, Inc.20251—
+5K251335Tera Lumbar Interbody Fusion System (Various PNs)Acuity Surgical Devices, LLC20251—
+5K250603AxTiHA® Stand-Alone ALIF SystemInnovasis20250—
+5K242771Tesera-k PL System and Tesera-k XL SystemKyocera Medical Technologies, Inc.20251—
+5K241487Interwedge® Standalone LateralFoundation Surgical Group, Inc.20241—
+5K233807LumiVy™ Lumbar IBF SystemVy Spine, LLC20241—
+5K241413sagAlign Lumbar Cage System (Various PNs)Acuity Surgical Devices, LLC20240—
+5K234077SPIRA® Anterior Lumbar SpacersCamber Spine Technologies20240—
+5K240699SCARLET® AC-TiSpineart SA20240—
+5K232256Alcantara Thoracolumbar Plate SystemCamber Spine Technologies, LLC20240—
+5K232792icotec Interbody Cage System (icotec Cervical Cage, icotec PLIF Lumbar Cage, icotec…Icotec AG20240—
+5K233359DOMINION Expandable Corpectomy SystemAstura Medical20242—
+5K232123MectaLIF Anterior Lag ExtensionMedacta International S.A.20231—