510(k) Report

Devices descending from K003155

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

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+8K261665CORUS™ Navigation System-GNProvidence Medical Technology, Inc.20260—
+8K260286Dynamo™ Spinal Cement; Salvo® Spine SystemSpine Wave, Inc.20260—
+8K253195TAURUS Posterior Occipital-Cervico-Thoracic Spinal SystemsZheJiang Decans Medical Devices Co., Ltd.20260—
+8K260571SIMPACT Sacroiliac Joint Fixation System GX Navigation InstrumentsLife Spine, Inc.20260—
+8K253894BMD Titanium Spinal Fusion SystemGlobal Biomedica s.r.o.20260—
+8K261374LigaPASS™ SystemMedicrea International S.A.S20260—
+8K253966PERLA® TL Posterior Thoraco-lumbar Fixation SystemSpineart SA20260—
+8K261067BEE PLIF CageNGMedical GmbH20260—
+8K253940M.U.S.T. Pedicle Screw System - ExtensionMedacta International S.A.20260—
+8K254274ARx® SAI Implant SystemLife Spine, Inc.20260—
+8K252774Uni-C Cervical Cage SystemZheJiang Decans Medical Devices Co., Ltd.20260—
+8K252240Spectrum Spine Cervical Cage System; Spectrum Spine Lumbar Cage SystemSpectrum Spine20260—
+8K252432Flex-Z™ Cervical CageSpinepoint, LLC20260—
+8K253615Invictus Bands SystemAlphatec Spine, Inc.20260—
+8K254045CarboClear® Posterior Cervical Screw System; CarboClear® Hybrid Posterior Cervical Screw…CarboFix Orthopedics, Ltd.20260—
+8K253559Ventana™ A Anterior Lumbar Interbody SystemSpinal Elements, Inc.20260—
+8K253545Vulcan Spinal SystemK2m, Inc.20260—
+8K253748Life Spine ProLift & ProLift Lateral and ProLift Lateral Fixated Expandable Spacer SystemLife Spine, Inc.20260—
+8K252885OLYMPIC Posterior Spinal Fixation System; MASADA Modular Spinal Fixation SystemAstura Medical20260—
+8K252461Swedge™ Pedicle Screw Fixation System Bezier RodSpinal Resources, Inc.20260—
+8K253266Titanium Interbody SystemSpine Innovation, LLC20260—
+8K253990KHEIRON® Spinal Fixation System, including patient specific K-RODS.M.A.I.O20262—
+8K252781MSFX Mikron Peek CagesMikron Makina Sanayi VE Tic. Ltd. Sti.20251—
+8K253721KHEIRON® Spinal Fixation System, including patient specific K-RODS.M.A.I.O20252—
+8K253093Vital™ Spinal Fixation SystemHighridge Medical, LLC20250—
+8K253200Cervical Spine Truss System - Stand Alone (CSTS-SA)4Web Medical, Inc.20250—
+8K252610ZSFab Lumbar Interbody SystemZsfab, Inc.20251—
+8K252742Navigated InstrumentsTyber Medical, LLC20251—
+8K253129Infinity™ OCT SystemMedtronic Sofamor Danek USA, Inc.20250—
+8K253377Expandable Titanium PLIF/TLIF SystemSpectrum Spine, Inc.20250—
+8K253249TriALTIS™ Spine SystemMedos International SARL20251—
+8K252346OLYMPIC Posterior Spinal Fixation System; MASADA Modular Spinal Fixation SystemAstura Medical20250—
+8K253094iFuse Bedrock Granite Implant SystemSI-BONE, Inc.20250—
+8K252437JAZZ Spinal SystemImplanet20250—
+8K250167Evolution Spine Navigation InstrumentsEvolution Spine20250—
+8K251060CORUS™ Navigation System-GXProvidence Medical Technology, Inc.20250—
+8K251073Innovasis Navigation Instruments (Vector G-E Navigation Instruments and the Excella G-E…Innovasis, Inc.202501
+8K241525ExcelsiusXR™Globus Medical, Inc.20250—
+8K251741PathLoc Lumbar Interbody Fusion Cage SystemL&K BIOMED Co., Ltd.20250—
+8K251804KHEIRON® Spinal Fixation System, including patient specific K-RODS.M.A.I.O20254—
+8K251719Momentum® Posterior Spinal Fixation SystemUlrich Medical USA, Inc.20250—
+8K251725ANAX™ OCT Spinal SystemCg Medtech Co., Ltd.20250—
+8K251459OneLIF™ Interbody Fusion SystemNovapproach Spine, LLC20250—
+8K251154RIVA Posterior Fixation System; RIVA Posterior Fixation System Navigation InstrumentsHt Medical D.B.A. Xenix Medical20251—
+8K251117Cervical Spine Truss System (CSTS)4Web Medical20250—
+8K243386Ventris Intervertebral Body Fusion DeviceAcuity Surgical Devices, LLC20252—
+8K250373ProLift Expandable Spacer SystemLife Spine, Inc.20251—
+8K250521NanoBone® SBX Putty ; NanoBone® QDBiocomposites, Ltd.20250—
+8K250556Porous Biologic ScaffoldVentris Medical20250—
+8K242890SPINEART Navigation Instrument SystemSpineart SA20253—
+8K242900VADER® Pedicle System and VADER®one Pedicle SystemIcotec AG20250—
+8K243673Xenco Medical CancelleX Cervical Interbody SystemXenco Medical, LLC20250—
+8K243668ProLift Pivot Expandable Spacer SystemLife Spine, Inc.20250—
+8K243706Mastergraft Matrix EXT; Mastergraft Strip; Mastergraft Putty; Mastergraft GranulesMedtronic Sofamor Danek, Inc.20250—
+8K243814NuVasive Pulse SystemGlobus Medical, Inc.20250—
+8K243670Idys® LIFClariance20240—
+8K241167BioSphere Putty; BioSphere MIS PuttySynergy Biomedical20240—
+8K2316554CIS® Chiron Spinal Fixation SystemSolco Biomedical Co., Ltd.20240—
+8K242764MediRod Pedicle Screw SystemCmf Medicon Surgical, Inc.20240—
+8K243004Xpine Spinal Fixation SystemJeil Medical Corporation20240—
+8K242361OZARK Cervical Plate System; PYRENEES® Cervical Plate System; EVEREST® Spinal System…Stryker Spine20241—
+8K242734ZSFab Cervical Interbody System; ZSFab Lumbar Interbody SystemZsfab20243—
+8K241077DeGen Medical Patient Specific Implant (PSI) SystemDegen Medical20242—
+8K241477aprevo® anterior lumbar interbody fusion device with interfixationCarlsmed, Inc.20246—
+8K242457EARP Interbody SystemRetropsoas Technologies, LLC20240—
+8K240889ARTFX Lumbar PEEK CagesArtfx Medical20244—
+8K242299NovaBone Putty - Synthetic Bioactive Bone GraftNovabone Products, LLC20241—
+8K242273Cove Putty, OsteoCove PuttySeaSpine Orthopedics Corporation202402
+8K241332aprevo® anterior and lateral lumbar interbody fusion device; aprevo® anterior lumbar…Carlsmed, Inc.20245—
+8K242509HAnano InterFuse (R) Modular InterbodyNext Orthosurgical20240—
+8K242069Eminent Spine Scoliosis Deformity Pedicle Screw SystemEminent Spine20240—
+8K240180Orthopeasia Spinal Fixation SystemOrthopeasia Co., Ltd.20240—
+8K241328aprevo® Anterior and Lateral Lumbar Interbody Fusion device (ALIF/LLIF); aprevo®…Carlsmed, Inc.20240—
+8K241464ARx® SAI Implant SystemLife Spine, Inc.20241—
+8K241019aprevo® TLIF-C Articulating SystemCarlsmed20244—
+8K240893ARTFX MEDICAL Cervical PEEK CagesArtfx Medical20244—
+8K233228Spine Navigation and Robotic-Assistance DeviceEcential Robotics202421
+8K241258Ingenix Spinal SystemIngenium Spine20240—
+8K241276Vector™ Pedicle Screw SystemInnovasis, Inc.202411
+8K240568DuraPro™ Oscillating SystemGlobus Medical, Inc.20240—
+8K232792icotec Interbody Cage System (icotec Cervical Cage, icotec PLIF Lumbar Cage, icotec…Icotec AG20240—
+8K240442MagnetOs PuttyKuros Biosciences B.V20243—
+8K233989CarboClear® Posterior Cervical Screw SystemCarboFix Orthopedics, Ltd.20242—
+8K232282aprevo® anterior and lateral lumbar interbody fusion device, aprevo® transforaminal…Carlsmed, Inc.20240—
+8K240507NuVasive AttraX ScaffoldNuvasive, Inc.20240—
+8K231850QUARTEX® Occipito-Cervico-Thoracic Spinal System ExcelsiusGPS® InstrumentsGlobus Medical, Inc.20242—
+8K240458Synthetic Bone PuttyVentris Medical20242—
+8K240459Cerament Bone Void FillerBonesupport AB20240—
+8K233640Segmental Plating System (SPS);IdentiTi SPS Interbody System;IdentiTi NanoTec SPS…Alphatec Spine, Inc.20245—
+8K233638VERZA™ High Speed DrillsGlobus Medical, Inc.20241—
+8K232347MagnetOs GranulesKuros Biosciences B.V20242—
+8K233744Curiteva Porous PEEK Lumbar Interbody Fusion SystemCuriteva, Inc.20242—
+8K233607MagnetOs Easypack PuttyKuros Biosciences B.V20232—
+8K232877FaSet Fixation System, UNITY Sacroiliac Joint Fixation System, Huvex Interspinous…K&J Consulting Corporation20231—
+8K231923Liberty SI Lateral Implant SystemSpinal Simplicity, LLC20230—
+8K233490SIGNAFUSE Bioactive Strip (SBS); SIGNAFUSE PuttyBioventus, LLC20232—
+8K230639Align Cervical Interbody Fusion SystemAcuity Surgical Devices, LLC20232—
+8K232611TruLift Micro Expandable Spacer System & TruLift Expandable Spacer SystemLife Spine, Inc.20232—
+8K233245MagnetOs Flex MatrixKuros Biosciences B.V20230—
+8K230927OptiMesh Multiplanar Expandable Interbody Fusion SystemSpineology, Inc.20231—