510(k) Report

Devices descending from K983485

171 later devices reach Synthes 1.3 MM Self-Drilling Screw through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K140037Optimus CMF SystemOsteonic Co., Ltd.20152—
+1K102656Synthes Dentoalveolar Bone Fixation SystemSynthes (Usa)20101—
+1K030806Bioplate Rigid Fixation Bone Plating System for Craniomaxillofacial SurgeryBioplate, Inc.20035—
+1K0232601.2MM Osteomed Auto-Drive Screw SystemOsteomed Corp.200224—
+1K022890Modified Screw Designs for Use with the Bioplate Rigid Fixation Bone Plating System for…Bioplate, Inc.20027—
+1K021850Synthes (Usa) 1.3 MM Craniofacial ScrewsSynthes (Usa)200232—
+1K013954Lorenz Self Drilling ScrewsWalter Lorenz Surgical, Inc.2002117—
+1K992106Modus System Self-Drilling ScrewsMedartis AG19990—
+2K253373Southern Craniomaxillofacial (CMF) SystemSouthern Medical (Pty), Ltd.20250—
+2K192655Depuy Synthes Maxillofacial Portfolio - MR ConditionalSynthes (USA) Products, LLC20190—
+2K160363Optimus CMF SystemOsteonic Co., Ltd.20160—
+2K141764Tristar Bone Graft Fixation SystemImpladent, Ltd.20143—
+2K121589Biomet Microfixation Facial Plating SystemBiomet Microfixation201251
+2K091812Frontier Devices Craniomaxillofacial, Cranio Closure, Orthognathic, Mandible…Frontier Devices, Inc.20104—
+2K091686Leforte Neurosystem Bone ScrewJeil Medical Corporation200929—
+2K073342Salvin Dental Specialties, Inc., Fixation ScrewSalvin Dental Specialties, Inc.20085—
+2K071035Ifs Bone Fixation DevicesInternal Fixation Systems, Inc.20073—
+2K063589Gso Bone Fixation FastenersGold Standard Orthopaedics, LLC20074—
+2K063506Lorenz Sternal Closure SystemWalter Lorenz Surgical, Inc.200687—
+2K051871Stoma Bone ScrewStorz AM Mark GmbH20051—
+2K031659Universal Neuro SystemStryker Instruments200312—
+2K032228Lorenz 2.4 Self Drilling ScrewsWalter Lorenz Surgical, Inc.2003101—
+2K031751Rapidfire Self Drilling ScrewsWalter Lorenz Surgical, Inc.200301
+2K031028The Bioplate Rigid Fixation Bone Plating System for Craniomaxillofacial SurgeryBioplate, Inc.20030—
+3K182609Delphos Implants Rigid Fixation SystemDelphos Implants - Ind.Com. Importacao E Exportacao DE20190—
+3K170697GBR systemSurgident20182—
+3K141123Alliance Spine Raas Cranial Plating SystemAlliance Partners, LLC20150—
+3K140216Orthopedic Fixation SystemsImpact Medical, LLC20140—
+3K132212Dental Bone Screws; Dental Bone Screws, Continuing; Screw System TX; Screw System TX…Hager& Meisinger GmbH20140—
+3K130613Cannulated Screw and Kirschner (Kwire) SystemLaura Cattabriga20141—
+3K132600Facial Prebent Plating with Virtual Surgical PlanningBiomet Microfixation20130—
+3K112457Leforte System Bone Plate & ScrewArkin Consulting Group201216—
+3K112812Leforte Neuro System Bone PlateJeil Medical Corporation201211—
+3K112557Stryker Universal Neuro 3 SystemStryker20129—
+3K111908Biomet Microfixation Sternal Closure SystemBiomet Microfixation, Inc.201178—
+3K110574Biomet Microfixation Sternalock Blu Sternal Closure SystemBiomet Microfixation, Inc.2011841
+3K110039Biomet Sports Medicine Sternal Closure SystemBiomet Sports Medicine20111—
+3K103084Neodent Graft ScrewJjgc Industria E Comercio DE Materiais Dentarios S20110—
+3K101835Medpor Fixation System-Cranial, Models 80080, 80079Porex Surgical, Inc.20100—
+3K033740Lorenz Sternal Closure SystemWalter Lorenz Surgical, Inc.2003100—
+4K252246Leforte MMF SystemJeil Medical Corporation20260—
+4K252661SternaFuse Ti Fixation SystemFusion Innovations, LLC20250—
+4K252758Cannulated Screw and Kirschner (K wire) SystemOrthonovis, Inc.20250—
+4K222367Save GBRDentis Co., Ltd.20230—
+4K202914SternaFuse Fixation SystemFusion Innovations, LLC20221—
+4K202889Able Medical Devices Valkyrie Thoracic Fixation SystemJm Longyear Manufacturing, LLC D.B.A. Able Medical Devices202139—
+4K182759BoniPlus Dental G-Mesh SystemMontjade Engineering Co., Ltd.20200—
+4K192162NeuroVention Cranial Fixation System, NuCrani Plates, KTC Burr Hole Cover, DC PlateNeurovention, LLC20200—
+4K191030Applied Biosystems™ 3500 Dx Genetic Analyzer and Applied Biosystems™ 3500xL Dx Genetic…Life Technologies Corporation20200—
+4K181806ARIX Sternal SystemJeil Medical Corporation20180—
+4K173579Thorecon™ Fixation SystemA & E Medical Corporation20181—
+4K170368Sterile NS SystemJeil Medical Corporation20170—
+4K150965LeForte System IIJeil Medical Corporation20151—
+4K151387Stryker Universal Neuro III System: UN III AXS Screw, UN III AXS Screwdriver BladeStryker20152—
+4K150581Tritium Sternal Cable Plate SystemPioneer Surgical Technology, Inc. (Dba Rti Surgical, Inc.)201544—
+4K141911Optimus Neuro SystemOsteonic Co., Ltd.20154—
+4K141644Innovasis Cranial SystemInnovasis, Inc.20140—
+4K142484Sternal Closure SystemJace Medical, LLC20141—
+4K141452Leforte Neuro System Bone Plate and ScrewJeil Medical Corporation20144—
+4K133785Tritium Sternal Cable Plate SystemPioneer Surgical Technology, Inc.2014451
+4K131775Universal Neuro 3 SystemStryker20130—
+4K131311Arix Foot SystemJeil Medical Corporation20139—
+4K122293Pioneer Sternal Cable Plate SystemPioneer Surgical Technology, Inc.201246—
+4K121302Biomet Microfixation Sternal Closure SystemBiomet Microfixation201275—
+4K120352Stryker Quikflap Sterile Procedure PackStryker2012418
+4K051165KLS Martin Sternal TalonKLS-Martin L.P.200662—
+4K053624Medicon Stern-a-Fix Sternal Closure SystemMedicon EG20060—
+5K241018KLS Martin Orthopedic Implants - MR ConditionalKLS-Martin L.P.20241—
+5K232515Valkyrie Thoracic Fixation SystemJm Longyear Manufacturing, LLC D/B/A Able Medical Devices20230—
+5K212391MCI-Neuro Fixation SystemMci Medical Concept Innovation, Inc.20220—
+5K220782IdentiTi™ Porous Ti Interbody System, IdentiTi™ NanoTec™ Interbody System, Transcend™…Alphatec Spine, Inc.202236—
+5K210099Meticuly Patient-Specific Titanium Mesh ImplantMeticuly Co., Ltd.20212—
+5K211695Valkyrie Thoracic Fixation SystemJm Longyear Manufacturing, LLC D/B/A Able Medical Devices20211—
+5K210290JACE Medical Thoracic Plating SystemJace Medical, LLC20210—
+5K190811Optimus NEURO System - Sterile KitOsteonic Co., Ltd.20191—
+5K192417ARIX Cannulated Screw SystemJeil Medical Corporation20191—
+5K183172Stryker SternalPlate SystemStryker20191—
+5K183352Optimus Neuro SystemOsteonic Co., Ltd.20192—
+5K181607Thorecon Rigid Fixation SystemA & E Medical Corporation201805
+5K170780ARIX Foot System (2.3/2.8)Jeil Medical Corporation20174—
+5K171152Stryker Universal Neuro III System AXS ScrewStryker20171—
+5K161876Tritium® Sternal Cable Plate SystemPioneer Surgical Technology, Inc., Dba Rti Surgical, Inc.201643—
+5K161896Biomet Microfixation Sternal Closure SystemBiomet Microfixation20164—
+5K161864ARIX Foot SystemJeil Medical Corporation20165—
+5K151019SternaLock® 360 Sternal Closure SystemBiomet Microfixation201543—
+5K142823Biomet Microfixation Thoracic Fixation SystemBiomet Microfixation201523—
+5K140309CranioplugOssdsign AB20142—
+5K122860KLS Martin Recon TalonKLS Martin L.P.201210—
+5K070169KLS Martin Quick Disc, Sternal Talon and Sternal Plating - SterileKLS Martin L.P.200761—
+6K252251Easymade-TICG Bio Co., Ltd.20260—
+6K252958METICULY Patient-specific titanium mesh implantMeticuly Co., Ltd.20260—
+6K250988KLS Martin Pure Pectus SystemKLS-Martin L.P.20250—
+6K243491SternalPlate ExpansionStryker Leibinger GmbH & Co KG20240—
+6K242260aprevo® Cervical ACDF; aprevo® Cervical ACDF-X; aprevo® Cervical ACDF-X NO CAMCarlsmed, Inc.20243—
+6K232829Versalock Rib and Sternum Plates SystemGM Dos Reis Industria e Comercio Ltda.20240—
+6K233967DePuy Synthes MatrixSTERNUM Fixation SystemSynthes GmbH20240—
+6K232432E3D™-A Interbody SystemEvolution Spine20248—
+6K231147Hammerdesis™ Interphalangeal Fusion SystemIntelivation20230—
+6K231208Stryker Resorbable Fixation SystemStryker Leibinger GmbH & Co KG20230—
+6K223513UniVy™ OsteoVy™-Ti Cervical IBF SystemVy Spine, LLC20231—