510(k) Report

Devices descending from K050058

727 later devices reach Theken Reveal VBR System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+8K201024Expandable Titanium PLIF/TLIF SystemSpectrum Spine, LLC20215—
+8K203520Blustone Synergy Interbody Fusion SystemBlustone Synergy, LLC20210—
+8K203576FORZA Ti Spacer SystemOrthofix, Inc.202161
+8K210155Duo Expandable Interbody Fusion SystemSpineology, Inc.20210—
+8K202398Ti3Z Cervical Interbody SystemZavation Medical Products, LLC20219—
+8K203327VERTACONNECT TLIF CageSignus Medizintechnik20210—
+8K203153CREO Stabilization System, Navigation Instruments, ExcelsiusGPSGlobus Medical, Inc.20211—
+8K201643ChoiceSpine Tiger Shark Cervical Spacer SystemChoice Spine, LLC20204—
+8K201287Impulse Interbody Fusion SystemDegen Medical20208—
+8K202812IdentiTi Cervical Standalone Interbody SystemAlphatec Spine, Inc.202067—
+8K203125Invictus™ OCT Spinal Fixation SystemAlphatec Spine, Inc.20200—
+8K203056Invictus™ Spinal Fixation SystemAlphatec Spine, Inc.202061—
+8K202198FlareHawk Interbody Fusion SystemIntegrity Implants, Inc.20202—
+8K202327Invictus™ OsseoScrew® SystemAlphatec Spine, Inc.20200—
+8K202666CONSTRUX Mini PTC Spacer SystemOrthofix, Inc.202010—
+8K201367FlareHawk TiHawk9 Interbody Fusion SystemIntegrity Implants, Inc.20202—
+8K200685RIGEL 3DR Anterior Cervical Interbody Fusion SystemMiRus, LLC20200—
+8K200936Invictus™ CT Spinal Fixation SystemAlphatec Spine, Inc.20203—
+8K200613Tritanium® X TL Expandable Curved Posterior Lumbar CageStryker Corporation20205—
+8K200312Tryptik TiSpineart20202—
+8K192897icotec Cervical CageIcotec AG20201—
+8K1803473d CageFims Co., Ltd.20190—
+8K192214CarboClear VBR SystemCarboFix Orthopedics, Ltd.20191—
+8K191339Zavation eZspand Interbody SystemZavation Medical Products, LLC20195—
+8K192018Endoskeleton TA Interbody Fusion Device, Endoskeleton TAS and TAS Hyperlordotic…Titan Spine, Inc.20191024
+8K191565Endoskeleton TCS Interbody Fusion DeviceTitan Spine, Inc.201901
+8K190291Addivation Medical Cervical Interbody SystemAddivation Medical, LLC20190—
+8K183243Velofix TLIF CageU&I Corporation20190—
+8K190889Republic Spine Restore Cervical Interbody Fusion SystemRepublic Spine, LLC20190—
+8K183588Choice Spine Hawkeye Vertebral Body Replacement (VBR) SystemChoicespine20195—
+8K182114FlareHawk Interbody Fusion SystemIntegrity Implants, Inc.20196—
+8K182584Lucent® XPSpinal Elements, Inc.20183—
+8K181921Solidity Vertebral Body ReplacementUlrich Medical USA20182—
+8K181829Velofix TLIF CageU&I Corporation20181—
+8K181837Spinal Elements Ti-Bond coated devicesSpinal Elements, Inc.201898—
+8K180990TirboLOX-L Lumbar IBFDCaptiva Spine, Inc.20181—
+8K180364HD LifeSciences Cervical IBFD SystemHd Lifesciences, LLC2018106—
+8K173159Cervical Spinal Truss System (CSTS) Interbody Fusion Device4Web, Inc.201812—
+8K173153Vertera Spine™ Coalesce™ Thoracolumbar Interbody Fusion SystemNu Vasive, Incorporated2017160—
+8K170961NuVasive CoRoent Small Interlock II SystemNu Vasive, Incorporated201718—
+9K262595VariLift-C Cervical Interbody Fusion SystemWenzel Spine, Inc.20260—
+9K262489BluEX Cervical Expandable Cage SystemL&K BIOMED Co., Ltd.20260—
+9K261205SPINEART Navigation Instrument SystemSpineart SA20260—
+9K254130C.A. Medical Interbody Fusion SystemC.A. Medical, LLC20260—
+9K260989Varion Thoracolumbar Fixation SystemKyocera Medical Technologies Inc. (KMTI)20260—
+9K260850Osteomni Spinal Cages SystemOsteomni, Inc.20260—
+9K253739SCRIPT™ Rods, CREO™ Stabilization System, REVERE® Stabilization System, REVERE® 4.5…Globus Medical, Inc.20260—
+9K252542LEO Spinal SystemZheJiang Decans Medical Devices Co., Ltd.20260—
+9K260216CD Horizon™ ModuLeX™ Fenestrated Screw Set; CD Horizon™ ModuLeX™ Spinal SystemMedtronic Sofamor Danek USA, Inc.20260—
+9K260011Foundation Surgical Navigated Lateral Disc Prep InstrumentsFoundation Surgical Group, Inc.20260—
+9K251829DeGen Medical Patient Specific Implant (PSI) SystemDegen Medical20250—
+9K250769Dakota LP SystemPrecision Spine, Inc.20250—
+9K252327CMORE® CT System; CMORE® CT System Navigated InstrumentsIcotec AG20251—
+9K253377Expandable Titanium PLIF/TLIF SystemSpectrum Spine, Inc.20250—
+9K253335CD Horizon™ Spinal SystemMedtronic Sofamor Danek USA, Inc.20250—
+9K253331PressON Spinal Fixation SystemNexus Spine20250—
+9K251522Mg OSTEOINJECT™; Mg OSTEOREVIVE™; Mg OSTEOCRETE™Bone Solutions, Inc.20251—
+9K243949OsteoFlo HydroFiberSurGenTec, LLC20250—
+9K242928Tesera-k SC SystemKyocera Medical Technologies, Inc.20250—
+9K243739AxCess® Expandable Interbody SystemElliquence, LLC20250—
+9K242350Spinal Alignment Solutions Pelvic Incidence (PI) Rod SystemSpinal Alignment Solutions, Inc.20241—
+9K242372Mg OSTEOREVIVE™, Mg OSTEOCRETE™Bone Solutions, Inc.20242—
+9K241892Cortera™ Spinal Fixation SystemXtant Medical Holdings, Inc.20242—
+9K241082INNOVERSE Navigation InstrumentsInnosys Co., Ltd.20240—
+9K232792icotec Interbody Cage System (icotec Cervical Cage, icotec PLIF Lumbar Cage, icotec…Icotec AG20240—
+9K234150Lucent® XPSpinal Elements20240—
+9K233951CD Horizon ModuLeX Spinal System (Shanks, Head Assemblies, and Set Screw)Medtronic Sofamor Danek USA, Inc.20245—
+9K233508iFuse Bedrock Granite® Implant SystemSI-BONE, Inc.20245—
+9K231766Skyway Anterior Cervical Plate SystemKyocera Medical Technologies Inc. (KMTI)20233—
+9K231241NanoHive Medical Lumbar Interbody SystemNanoHive Medical, LLC20230—
+9K223418DeGen Impulse AM™ SystemDegen Medical20236—
+9K223174X-Pac Expandable LLIF Cage SystemExpanding Innovations, Inc.20233—
+9K223362Cervical Spine Truss System - Stand Alone (CSTS-SA) Interbody Fusion Device4Web Medical, Inc.20233—
+9K221266Cervical Spine Truss System (CSTS) Interbody Fusion Device4Web Medical, Inc.20233—
+9K211785CASSATT™ SIJ Fixation SystemCtl Medical Corporation20220—
+9K222383Anteralign™ LS Spinal System with Titan nanoLOCK™ Surface Technology MAZORX Stealth (TM)…Medtronic Sofamor Danek USA, Inc.20220—
+9K221049Zavation VariSync Plate System and VariSync Spacer SystemZavation Medical Products, LLC20226—
+9K221180Anteralign (TM) Spinal System with Titan NanoLOCK Surface Technology Navigated InstrumentsMedtronic Sofamor Danek USA, Inc.20222—
+9K212527Cervical Spine Truss System Plating Solution (CSTS-PS)4Web Medical, Inc.20220—
+9K212358Romero Cervical CageSpineup, Inc.20226—
+9K213460Invictus Spinal Fixation SystemAlphatec Spine, Inc.202117—
+9K210470C-CURVE Interbody Fusion DeviceMedicrea International SA20210—
+9K210521DEXA-C Cervical Interbody SystemAurora Spine, Inc.20210—
+9K203342CONSTRUX Mini Ti Spacer SystemOrthofix, Inc.202191
+9K202298Lucent XP, Lucent XP CurvedSpinal Elements, Inc.20202—
+9K192145Galileo Vertebral Body Replacement DeviceBright Spine20201—
+9K191581Endoskeleton TL Interbody Fusion Device, Endoskeleton TL Hyperlordotic Interbody Fusion…Titan Spine, Inc.202081—
+9K191477AEON-C Stand Alone SystemHuvexel Co., Ltd.201910—
+9K190870Cervical Spinal Truss System-Stand Alone (CSTS-SA)4Web, Inc.201910—
+9K190546NEXXT MATRIXX Stand Alone Cervical SystemNexxt Spine, LLC201993—
+9K181621Stable-C Interbody SystemNexus Spine, LLC20187—
+9K181229TirboLOX-C Cervical IBFDCaptiva Spine, Inc.20180—
+10K263172SAS MIS Pelvic Incidence RodsSpinal Alignment Solutions, Inc.20260—
+10K254274ARx® SAI Implant SystemLife Spine, Inc.20260—
+10K254045CarboClear® Posterior Cervical Screw System; CarboClear® Hybrid Posterior Cervical Screw…CarboFix Orthopedics, Ltd.20260—
+10K253200Cervical Spine Truss System - Stand Alone (CSTS-SA)4Web Medical, Inc.20250—
+10K252742Navigated InstrumentsTyber Medical, LLC20251—
+10K252322SIros-X SystemGenesys Spine20250—
+10K253094iFuse Bedrock Granite Implant SystemSI-BONE, Inc.20250—
+10K251003X-PAC® LLIF Expandable Lateral Cage SystemExpanding Innovations, Inc.20250—