510(k) Report

Devices descending from K033109

1,218 later devices reach Ellys and Aurys Vertebral Body Replacements through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+7K250373ProLift Expandable Spacer SystemLife Spine, Inc.20251—
+7K250603AxTiHA® Stand-Alone ALIF SystemInnovasis20250—
+7K241783FortiVy™ OsteoVy™ Lumbar IBFVy Spine, LLC20250—
+7K243802aprevo® anterior and lateral lumbar interbody fusion device, aprevo® anterior lumbar…Carlsmed, Inc.20253—
+7K243461Calibrate Interbody SystemsAlphatec Spine, Inc.20250—
+7K243668ProLift Pivot Expandable Spacer SystemLife Spine, Inc.20250—
+7K243814NuVasive Pulse SystemGlobus Medical, Inc.20250—
+7K242734ZSFab Cervical Interbody System; ZSFab Lumbar Interbody SystemZsfab20243—
+7K243015Skyway Anterior Cervical Plate SystemKyocera Medical Technologies, Inc.20242—
+7K241077DeGen Medical Patient Specific Implant (PSI) SystemDegen Medical20242—
+7K242589Scarlet® AL-TSpineart SA20240—
+7K233947KLIMT™ Expandable Lumbar Interbody Fusion (LIF) Cage SystemCtl Medical Corporation20240—
+7K240889ARTFX Lumbar PEEK CagesArtfx Medical20244—
+7K233807LumiVy™ Lumbar IBF SystemVy Spine, LLC20241—
+7K232996Iatrical Interbody Lumbar Fusion Systems (Model ALIF, Model TLIF, Model LLIF)Shanghai Iatrical-Ti Technologies CO, Ltd.20240—
+7K240326Solar™ Lumbar Interbody Fusion SystemDegen Medical, Inc.20244—
+7K241321Juliet® Ti LL Lumbar Interbody DeviceSpineart SA20240—
+7K241519Invictus® Small Stature Spinal Fixation SystemAlphatec Spine, Inc.20242—
+7K233228Spine Navigation and Robotic-Assistance DeviceEcential Robotics202421
+7K240568DuraPro™ Oscillating SystemGlobus Medical, Inc.20240—
+7K240872Erisma® Deformity Spinal System; Erisma® Lp Spinal Fixation SystemClariance20241—
+7K233638VERZA™ High Speed DrillsGlobus Medical, Inc.20241—
+7K233694Meridian Interbody System; WaveForm A Interbody SystemSeaSpine Orthopedics Corporation20248—
+7K230872Halis™ Lumbar Cage System, Lydia™ Anterior Lumbar Fusion System, Dica™ Direction…Shanghai Sanyou Medical Co, Ltd.20231—
+7K232611TruLift Micro Expandable Spacer System & TruLift Expandable Spacer SystemLife Spine, Inc.20232—
+7K233084Peridot-PT Anterior Cervical Intervertebral body fusion System, Peridot-PT…Gbs Commonwealth Co., Ltd.20232—
+7K232345ATEC Posterior Navigated Disc Prep InstrumentsAlphatec Spine, Inc.20232—
+7K231836ClariVy™ Cervical IBF SystemVy Spine, LLC20232—
+7K231899HAtetracell™-C Titanium Cervical IBF SystemInnovasis, Inc.20232—
+7K232822Peridot-TD Spacer system (The Peridot-TD Intervertebral body fusion system), Anterior…Gbs Commonwealth Co., Ltd.20232—
+7K232341CarboClear® Pedicle Screw SystemCarboFix Orthopedics, Ltd.20234—
+7K231680AccelFix Lumbar Expandable Cage SystemL&K BIOMED Co., Ltd.20231—
+7K231799INERTIA® CONNEXX™ Modular Pedicle Screw SystemNexxt Spine, LLC20230—
+7K231808QUASAR Standalone ACIF SystemGS Medical Co., Ltd.20230—
+7K231241NanoHive Medical Lumbar Interbody SystemNanoHive Medical, LLC20230—
+7K230894NuVasive Modulus ALIF SystemNu Vasive, Incorporated20234—
+7K231199Solar Lumbar Interbody Fusion SystemDegen Medical20235—
+7K230414ClariVy™ Cervical IBF SystemVy Spine, LLC20233—
+7K223513UniVy™ OsteoVy™-Ti Cervical IBF SystemVy Spine, LLC20231—
+7K221324ENZA-O Titanium Lateral Anterior Lumbar Interbody Fusion (ALIF)Camber Spine Technologies20230—
+7K223418DeGen Impulse AM™ SystemDegen Medical20236—
+7K223688CONDUIT™ Lateral Lumbar Intervertebral Fusion Cage, CONDUIT™ InstrumentsMedos International Sàrl20230—
+7K223174X-Pac Expandable LLIF Cage SystemExpanding Innovations, Inc.20233—
+7K223413Pisces™-SA STANDALONE ALIF Interbody SystemOsseus Fusion Systems20233—
+7K223494CD Horizon Spinal SystemMedtronic202317—
+7K223140AEON-C™ Stand Alone SystemDio Medical, Inc.20222—
+7K221926Invictus® Bone Cement, Invictus Spinal Fixation SystemAlphatec Spine, Inc.202214—
+7K222732WaveForm A Interbody SystemSeaSpine Orthopedics Corporation20229—
+7K221545MectaLIF Anterior ExtensionMedacta International S.A.202226
+7K221751NuVasive Cohere ALIF System Intervertebral Body Fusion DeviceNu Vasive, Incorporated20223—
+7K222276CONDUIT Cages; FIBERGRAFT BG PuttyDepuy Spine202229—
+7K221646CD HORIZON™ ASTUTE™ SPINAL SYSTEM; CD HORIZON™ Growth Rod Conversion Set; CD HORIZON™…Medtronic Sofamor Danek USA, Inc.202220—
+7K220953ChoiceSpine TigerShark™ M, Modular Interbody SystemChoice Spine, LLC20220—
+7K221325CONDUIT Lateral Switch PlateMedos International SARL20221—
+7K221403Cortera Spinal Fixation SystemSurgalign Spine Technologies202232
+7K220449DePuy CONDUIT LLIF SQUID InserterEnztec Limited20220—
+7K221180Anteralign (TM) Spinal System with Titan NanoLOCK Surface Technology Navigated InstrumentsMedtronic Sofamor Danek USA, Inc.20222—
+7K220115ANTARES 3DR Standalone Anterior Lumbar Interbody Fusion SystemMiRus, LLC20220—
+7K211837Altus Spine Interbody Standalone Fusion SystemAltus Partners, LLC20220—
+7K211320CAPRI Corpectomy Cage SystemK2m, Inc.20222—
+7K214011Catalyft™ PL Expandable Interbody System Navigated Instruments, Anteralign™ TL Spinal…Medtronic Sofamor Danek USA, Inc.20221—
+7K213951FORZA XP Expandable Spacer SystemOrthofix US, LLC20224—
+7K203714NuVasive Thoracolumbar Interbody Systems: NuVasive CoRoent Thoracolumbar System…Nu Vasive, Incorporated202166—
+7K212823DePuy CONDUIT LLIF Angled InsertersEnztec Limited20213—
+7K201793EDEN Peek CageJmt Co., Ltd.20210—
+7K212540Explorer TO SystemSeaSpine Orthopedics Corporation20213—
+7K211616ExcelsiusHubGlobus Medical, Inc.20219Class I
+7K210800IO Expandable Lumbar Interbody Fusion SystemMiRus, LLC20212—
+7K211205Prase-C Anterior Cervical Plate SystemGbs Commonwealth Co., Ltd.20210—
+7K203003Pantheon IBFDPantheon Spinal20210—
+7K210542aprevo Transforaminal IBFCarlsmed, Inc.202112—
+7K210728CONDUIT InstrumentsMedos International SARL20215—
+7K201671A-Link ZAcuity Surgical Devices, LLC202125—
+7K200919Idys ALIF 3DTiClariance20210—
+7K202032Idys LLIF 3DTiClariance, Sas20210—
+7K210359Hexanium TLIFSpinevision, S.A.S.20211—
+7K210271NuVasive Modulus ALIF SystemNu Vasive, Incorporated20215—
+7K203531XYPAN Expandable Lumbar Cage SystemAegis Spine, Inc.20213—
+7K202637F3D Corpectomy SystemCorelink, LLC20201—
+7K203125Invictus™ OCT Spinal Fixation SystemAlphatec Spine, Inc.20200—
+7K202034aprevo Intervertebral Body Fusion DeviceCarlsmed, Inc.202017—
+7K203056Invictus™ Spinal Fixation SystemAlphatec Spine, Inc.202061—
+7K200316UNiD IB3D ALIFMedicrea International SA20200—
+7K202327Invictus™ OsseoScrew® SystemAlphatec Spine, Inc.20200—
+7K200047ExcelsiusGPS Cranial 1.0 ModuleGlobus Medical, Inc.202053
+7K200879SeaSpine Meridian System, SeaSpine Regatta Lateral SystemSeaSpine Orthopedics Corporation202060—
+7K200920Idys ALIF ZP 3DTiClariance, Sas20203—
+7K200235KONG-TL VBR System, KONG-C VBR SystemIcotec AG20201—
+7K200936Invictus™ CT Spinal Fixation SystemAlphatec Spine, Inc.20203—
+7K200969NEXXT MATRIXX SystemNexxt Spine, LLC20200—
+7K192145Galileo Vertebral Body Replacement DeviceBright Spine20201—
+7K200613Tritanium® X TL Expandable Curved Posterior Lumbar CageStryker Corporation20205—
+7K200052CONSTRUX Mini PTC Spacer System, FORZA PTC Spacer System, PILLAR SA PTC Spacer SystemOrthofix, Inc.202013—
+7K200048MectaLIF Anterior SimpleMedacta International S.A.20200—
+7K193506NuVasive X-Core Expandable VBR System, NuVasive X-Core Mini Cervical Expandable VBR SystemNu Vasive, Incorporated20201—
+7K193412NEXXT MATRIXX SystemNexxt Spine, LLC20201—
+7K193255Largo PEEK Interbody SystemFlospine, LLC20201—
+7K193521Steerable Plateau TiLife Spine, Inc.20201—
+7K193258ProLift Expandable SystemLife Spine, Inc.20203—
+7K192993Scarlet AL-TSpineart20201—