510(k) Report

Devices descending from K854886

241 later devices reach Wuerzburg Titanium Mini Bone Plates & Bone Screws through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K121624Biomet Microfixation Neuro Plating SystemBiomet Microfixation201252
+1K121589Biomet Microfixation Facial Plating SystemBiomet Microfixation201251
+1K062819Bioplate Rigid Bone Plating System for Craniomaxillofacial SurgeryBioplate, Inc.20063—
+1K032520Ortrautek Trauma SystemTekka20030—
+1K031989Ortrautek Orthognathic SystemTekka20035—
+1K022185Universal CMF SystemStryker Instruments200233—
+1K021684The Bioplate Rigid Fixation Bone Plating System for Craniomaxillofacial SurgeryBioplate, Inc.20027—
+1K963741Leibinger Luhr Small Craniomaxillofacial Bone ScrewsHowmedica Leibinger, Inc.1997188—
+1K963739Leibinger - Luhr Small Orthopedic Bone ScrewsHowmedica Leibinger, Inc.1997144—
+1K961120Marker System for Stereotaxic NavigationHowmedica Leibinger, Inc.199617—
+2K220360Tandry CMF Plate SystemMicroware Precision Co., Ltd.20220—
+2K221855Universal CMF SystemStryker Leibinger GmbH & Co KG20221—
+2K182609Delphos Implants Rigid Fixation SystemDelphos Implants - Ind.Com. Importacao E Exportacao DE20190—
+2K170773Stryker Universal MeshStryker20171—
+2K172572Stryker Upper-Face AXS screws and Mid-Face AXS screwsStryker20170—
+2K171364MP LeFort I PlatesStryker20170—
+2K161821Stryker Universal MeshStryker20162—
+2K141911Optimus Neuro SystemOsteonic Co., Ltd.20154—
+2K140037Optimus CMF SystemOsteonic Co., Ltd.20152—
+2K132600Facial Prebent Plating with Virtual Surgical PlanningBiomet Microfixation20130—
+2K091807Medpor Fixation SystemPorex Surgical, Inc.20100—
+2K091812Frontier Devices Craniomaxillofacial, Cranio Closure, Orthognathic, Mandible…Frontier Devices, Inc.20104—
+2K092192Waypoint Stereotactic SystemFHC, Inc.20104—
+2K073006Osteotrans -MX Bioabsorbable Bone Fixation SystemTakiron Co., Ltd.20082—
+2K080694Osteomed Modular Locking Fixation SystemOsteomed LP20082—
+2K072463Satyrne Interflex Mandibular Fixation SystemSatyrne Medical20070—
+2K051293Cranion Cranial Fixation System; Fixlock; Cranial Solutions; Ceremed Fixation SystemCeremed, Inc.20050—
+2K041651Stryker Leibinger Skeletal Anchoring SystemStryker Leibinger20044—
+2K032534Synthes AfsSynthes Spine200443—
+2K031659Universal Neuro SystemStryker Instruments200312—
+2K031028The Bioplate Rigid Fixation Bone Plating System for Craniomaxillofacial SurgeryBioplate, Inc.20030—
+2K023810Modification to Bioplate Rigid Fixation Bone Plating System for Craniomaxillofacial…Bioplate, Inc.20021—
+2K010427Lorenz Fiducail ScrewWalter Lorenz Surgical, Inc.20011—
+2K982463Extracranial Radiotherapy SystemHowmedica, Inc.19988—
+2K963502Csco Forehead Fixation SystemHowmedica Corp.19970—
+2K970912Leibinger Self-Drilling ScrewHowmedica Leibinger, Inc.1997143—
+3K252930AQUA Laminoplasty SystemsZheJiang Decans Medical Devices Co., Ltd.20260—
+3K253373Southern Craniomaxillofacial (CMF) SystemSouthern Medical (Pty), Ltd.20250—
+3K240651MRI UniversalStryker Leibinger GmbH & Co KG20240—
+3K232471Vy Spine™ VyLam™ Laminoplasty SystemVy Spine, LLC20231—
+3K231141STarFix Designer Software C0265FHC, Inc.20230—
+3K231232Curiteva Laminoplasty SystemCuriteva, Inc.20232—
+3K223552Brainlab Elements – Trajectory Planning (2.6), Elements Stereotaxy, Elements Lead…Brainlab AG20230—
+3K212391MCI-Neuro Fixation SystemMci Medical Concept Innovation, Inc.20220—
+3K190811Optimus NEURO System - Sterile KitOsteonic Co., Ltd.20191—
+3K191927Hinged Laminoplasty SystemLife Spine, Inc.20190—
+3K183352Optimus Neuro SystemOsteonic Co., Ltd.20192—
+3K182425Universal Mesh - SterileStryker Leibinger GmbH & Co KG201801
+3K181717Life Spine Laminoplasty SystemLife Spine, Inc.20181—
+3K173215Choice Spine Laminoplasty™ Fixation SystemChoicespine, LP20184—
+3K170725Stryker Universal MeshStryker20170—
+3K160363Optimus CMF SystemOsteonic Co., Ltd.20160—
+3K160385Precision ScrewCryptych Pty, Ltd.20160—
+3K143338Argulated Locking PlatesOsteomed LP20150—
+3K141123Alliance Spine Raas Cranial Plating SystemAlliance Partners, LLC20150—
+3K141764Tristar Bone Graft Fixation SystemImpladent, Ltd.20143—
+3K132611Microtable SystemFred Haer Company, Inc.20141—
+3K132740Spinefrontier Lesplasty Posterior Cervical Laminoplasty SystemSpinefrontier, Inc.20130—
+3K122822Spectrum Spine Laminoplasty Plating SystemSpectrum Spine, LLC20135—
+3K121606Resorb-X GKLS-Martin L.P.20130—
+3K121276Neuro Vention Laminplasty Plating SystemNeurovention, LLC20120—
+3K111048Synthes Scout Tack FixationSynthes Spine20120—
+3K113802Escalate Laminoplasty SystemStryker Spine20127—
+3K112557Stryker Universal Neuro 3 SystemStryker20129—
+3K101835Medpor Fixation System-Cranial, Models 80080, 80079Porex Surgical, Inc.20100—
+3K103284Laminoplasy Plating SystemAesculap Implant Systems, Inc.20101—
+3K100805Gallery Laminoplasty Fixation SystemBiomet Spine (Aka Ebi, LLC)20103—
+3K091994Mountaineer Laminoplasty SystemDepuy Spine, Inc.201017—
+3K091051Bollard Miniplate Skeletal Anchorage SystemTita-Link20091—
+3K091623Laminoplasty Fixation SystemNuvasive, Inc.20097—
+3K090354Laminoplasty Plating SystemAesculap Implant System, Inc.20092—
+3K080664Relieve Laminoplasty Fixation SystemGlobus Medical, Inc.200811—
+3K073342Salvin Dental Specialties, Inc., Fixation ScrewSalvin Dental Specialties, Inc.20085—
+3K063386Lorenz Orthodontic Anchorage SystemWalter Lorenz Surgical, Inc.20070—
+3K051798Osteomed Orthodontic Anchor Plating SystemOsteomed LP20060—
+3K043338Blakstone Laminoplasty Fixation SystemBlackstone Medical, Inc.200517—
+3K0232601.2MM Osteomed Auto-Drive Screw SystemOsteomed Corp.200224—
+3K992106Modus System Self-Drilling ScrewsMedartis AG19990—
+3K991336Bodyloc Whole Body Stereotactic Localizer System for RadiotherapyMedical Instrumentation & Diagnostics Corp.(Midco)19997—
+3K974785Auto-Drive Bone ScrewOsteomed Corp.1998141—
+4K243137Curiteva Porous PEEK Laminoplasty SystemCuriteva, Inc.20241—
+4K242784Vy Spine™ VyLam™ Laminoplasty SystemVy Spine, LLC20240—
+4K233703Bone Anchor (NGS-BA-01)ClearPoint Neuro, Inc.20240—
+4K222684XIA® 4.5 Spinal System, XIA® 4.5 Cortical Trajectory, XIA® 3 Spinal System, Serrato®…Stryker Spine20234—
+4K2117123° Anterior Cervical Plating System, Reliant Anterior Cervical Plating System, Unity…Orthofix US, LLC20220—
+4K210360Neuro Plating System, Neuro Plating System Plates (NST304M02A and 61 Models), Neuro…Osteonic Co., Ltd.20220—
+4K202309Epic Anterior Thoracolumbar Plate System, Gallery Laminoplasty Fixation System, Concero…Zimmer Biomet Spine, Inc.20200—
+4K192162NeuroVention Cranial Fixation System, NuCrani Plates, KTC Burr Hole Cover, DC PlateNeurovention, LLC20200—
+4K192281AEGIS Anterior Lumbar Plate System, ALC Dynamized Fixation System, Anterior ISOLA Spine…Medos International SARL20190—
+4K181846ASSURE Anterior Cervical Plate System, PROVIDENCE Anterior Cervical Plate System, VIP…Globus Medical, Inc.20184—
+4K173623Anchor plateBiomaterials Korea, Inc.20180—
+4K170697GBR systemSurgident20182—
+4K180156SP-Fix® Spinous Process Fixation Plate, RELIEVE® Laminoplasty Fixation SystemGlobus Medical, Inc.20185—
+4K171413HAVEN™ Laminoplasty System, CANOPY® Laminoplasty Fixation SystemGlobus Medical, Inc.20176—
+4K160114Xspan Laminoplasty Fixation SystemX-Spine Systems, Inc.20160—
+4K153735Release Laminoplasty Fixation SystemPioneer Surgical Technology, Inc. (Dba Rti Surgical, Inc.)20160—
+4K151195OsteoMed IMF ScrewOsteomed20150—
+4K151387Stryker Universal Neuro III System: UN III AXS Screw, UN III AXS Screwdriver BladeStryker20152—
+4K131775Universal Neuro 3 SystemStryker20130—
+4K130830Integra Laminoplasty SystemSeaspine, Inc.20132—