510(k) Report

Devices descending from K944565

522 later devices reach KLS-Martin Micro Osteosythesis System (1.5MM) through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K252573KLS Martin Cranial Implants - MR Conditional; K944565: KLS-Martin Micro Osteosynthesis…KLS-Martin L.P.20250—
+1K241314KLS Martin Oral-Max Implants MR Conditional (bundled)KLS-Martin L.P.20241—
+1K112557Stryker Universal Neuro 3 SystemStryker20129—
+1K073307Max-Face Maxillofacial Osteosynthesis SystemBio-Technology USA, Inc.20080—
+1K082757Modified Sterile Plate & Screw Kit Configurations for Use with Bioplate Titanium…Bioplate, Inc.200801
+1K060177KLS Martin Rigid Fixation - SterileKLS Martin L.P.200665—
+1K040891KLS Martin Ortho Anchorage System (Plates)KLS-Martin L.P.20047—
+1K040598KLS Martin Hand Plating SystemKLS-Martin L.P.2004360—
+1K031989Ortrautek Orthognathic SystemTekka20035—
+1K023665Modification to Bioplate Rigid Bone Plating System for Craniomaxillofacial SurgeryBioplate, Inc.20020—
+1K021618Osa Rigid Internal Fixation SystemOsteomed Corp.20026—
+1K022033Sterile Plate & Screw Kit Configurations for Use with the Bioplate Titanium Fixation…Bioplate, Inc.20021—
+1K021684The Bioplate Rigid Fixation Bone Plating System for Craniomaxillofacial SurgeryBioplate, Inc.20027—
+1K974785Auto-Drive Bone ScrewOsteomed Corp.1998141—
+1K970912Leibinger Self-Drilling ScrewHowmedica Leibinger, Inc.1997143—
+2K260137KLS Martin IPS Oral-Max Implants - MR Conditional; Individual Patient Solutions - Ti…KLS-Martin L.P.20260—
+2K241018KLS Martin Orthopedic Implants - MR ConditionalKLS-Martin L.P.20241—
+2K192162NeuroVention Cranial Fixation System, NuCrani Plates, KTC Burr Hole Cover, DC PlateNeurovention, LLC20200—
+2K151195OsteoMed IMF ScrewOsteomed20150—
+2K151387Stryker Universal Neuro III System: UN III AXS Screw, UN III AXS Screwdriver BladeStryker20152—
+2K141489Linos Moh Hand Plating SystemKLS Martin L.P.20143—
+2K131775Universal Neuro 3 SystemStryker20130—
+2K131657Flower Small and Medium Implant SetFlower Orthopedics Corporation2013111
+2K122049Neuropro Low Profile Cranial Plating SystemKinamed, Inc.20130—
+2K123562Flower Small and Medium Bone ImplantsFlower Orthopedics Corporation2013142
+2K120352Stryker Quikflap Sterile Procedure PackStryker2012418
+2K091812Frontier Devices Craniomaxillofacial, Cranio Closure, Orthognathic, Mandible…Frontier Devices, Inc.20104—
+2K091051Bollard Miniplate Skeletal Anchorage SystemTita-Link20091—
+2K073342Salvin Dental Specialties, Inc., Fixation ScrewSalvin Dental Specialties, Inc.20085—
+2K070169KLS Martin Quick Disc, Sternal Talon and Sternal Plating - SterileKLS Martin L.P.200761—
+2K063473Synthes Orthodontic Bone Anchor SystemSynthes (Usa)20070—
+2K063386Lorenz Orthodontic Anchorage SystemWalter Lorenz Surgical, Inc.20070—
+2K062819Bioplate Rigid Bone Plating System for Craniomaxillofacial SurgeryBioplate, Inc.20063—
+2K051798Osteomed Orthodontic Anchor Plating SystemOsteomed LP20060—
+2K051293Cranion Cranial Fixation System; Fixlock; Cranial Solutions; Ceremed Fixation SystemCeremed, Inc.20050—
+2K050868MaxlockOrthohelix Surgical Designs, Inc.2005343—
+2K031028The Bioplate Rigid Fixation Bone Plating System for Craniomaxillofacial SurgeryBioplate, Inc.20030—
+2K030806Bioplate Rigid Fixation Bone Plating System for Craniomaxillofacial SurgeryBioplate, Inc.20035—
+2K023810Modification to Bioplate Rigid Fixation Bone Plating System for Craniomaxillofacial…Bioplate, Inc.20021—
+2K0232601.2MM Osteomed Auto-Drive Screw SystemOsteomed Corp.200224—
+2K022890Modified Screw Designs for Use with the Bioplate Rigid Fixation Bone Plating System for…Bioplate, Inc.20027—
+2K013954Lorenz Self Drilling ScrewsWalter Lorenz Surgical, Inc.2002117—
+2K992106Modus System Self-Drilling ScrewsMedartis AG19990—
+3K250988KLS Martin Pure Pectus SystemKLS-Martin L.P.20250—
+3K173623Anchor plateBiomaterials Korea, Inc.20180—
+3K170687Flower Bone Screw SetFlower Orthopedics Corporation20170—
+3K171152Stryker Universal Neuro III System AXS ScrewStryker20171—
+3K170124Level One Hand Plating SystemKLS Martin L.P.20172—
+3K153482KLS Martin Thoracic Plating SystemKLS-Martin L.P.20169—
+3K151983KLS Martin LSS Plating SystemKLS Martin L.P.201645—
+3K152306MotoBand¿ CP Implant SystemCrossroads Extremity Systems, LLC20157—
+3K141764Tristar Bone Graft Fixation SystemImpladent, Ltd.20143—
+3K142484Sternal Closure SystemJace Medical, LLC20141—
+3K140309CranioplugOssdsign AB20142—
+3K142306Flower Upper Extremity Plating SetFlower Orthopedics Corporation20140—
+3K133930Flower Rear Foot Plating Set, Flower Calcaneus Planting Set, Flower Rearfoot Plating SetFlower Orthopedics Corporation201406
+3K133102Flower Ankle Plating SetFlower Orthopedics Corporation20130—
+3K132248Flower Bone Screw SetFlower Orthopedics Corporation20131—
+3K122860KLS Martin Recon TalonKLS Martin L.P.201210—
+3K121589Biomet Microfixation Facial Plating SystemBiomet Microfixation201251
+3K101484Compressyn BandDallen Medical20115—
+3K103084Neodent Graft ScrewJjgc Industria E Comercio DE Materiais Dentarios S20110—
+3K073006Osteotrans -MX Bioabsorbable Bone Fixation SystemTakiron Co., Ltd.20082—
+3K073624Modular Foot SystemOrthohelix Surgical Designs, Inc.20083421
+3K071035Ifs Bone Fixation DevicesInternal Fixation Systems, Inc.20073—
+3K063589Gso Bone Fixation FastenersGold Standard Orthopaedics, LLC20074—
+3K063506Lorenz Sternal Closure SystemWalter Lorenz Surgical, Inc.200687—
+3K031659Universal Neuro SystemStryker Instruments200312—
+3K032228Lorenz 2.4 Self Drilling ScrewsWalter Lorenz Surgical, Inc.2003101—
+3K031751Rapidfire Self Drilling ScrewsWalter Lorenz Surgical, Inc.200301
+4K232986VariTrax Sternal CircumFixation SystemCircumfix Solutions, Inc.20240—
+4K231208Stryker Resorbable Fixation SystemStryker Leibinger GmbH & Co KG20230—
+4K222397KLS Martin Level One Rib Fixation SystemKLS-Martin L.P.20233—
+4K221938KLS Martin Pure Pectus SystemKLS Martin L.P.20236—
+4K210290JACE Medical Thoracic Plating SystemJace Medical, LLC20210—
+4K202889Able Medical Devices Valkyrie Thoracic Fixation SystemJm Longyear Manufacturing, LLC D.B.A. Able Medical Devices202139—
+4K182609Delphos Implants Rigid Fixation SystemDelphos Implants - Ind.Com. Importacao E Exportacao DE20190—
+4K181539OSSDSIGN CranioplugOssdsign AB20181—
+4K170697GBR systemSurgident20182—
+4K173710MotoBAND CP Implant SystemCrossroads Extremity Systems, LLC201841
+4K160300MotoBand (TM) CP Implant SystemCrossroads Extremity Systems, LLC20166—
+4K141123Alliance Spine Raas Cranial Plating SystemAlliance Partners, LLC20150—
+4K140037Optimus CMF SystemOsteonic Co., Ltd.20152—
+4K140216Orthopedic Fixation SystemsImpact Medical, LLC20140—
+4K130613Cannulated Screw and Kirschner (Kwire) SystemLaura Cattabriga20141—
+4K132600Facial Prebent Plating with Virtual Surgical PlanningBiomet Microfixation20130—
+4K130431Compressyn BandDallen Medical, Inc.20134—
+4K121606Resorb-X GKLS-Martin L.P.20130—
+4K113014Claw II Polyaxial Compression System and Ortholoc 3DSI Locking ScrewsWrightmedicaltechnologyinc20129712
+4K111908Biomet Microfixation Sternal Closure SystemBiomet Microfixation, Inc.201178—
+4K110574Biomet Microfixation Sternalock Blu Sternal Closure SystemBiomet Microfixation, Inc.2011841
+4K110039Biomet Sports Medicine Sternal Closure SystemBiomet Sports Medicine20111—
+4K101835Medpor Fixation System-Cranial, Models 80080, 80079Porex Surgical, Inc.20100—
+4K102156Maxlock Extreme Extremity Plating System Distal Radius Plates and ScrewsOrthohelix Surgical Designs, Inc.20101191
+4K101962Mini Maxlock Extreme Plating SystemOrthohelix Surgical Designs, Inc.2010851
+4K100776Synthes 2.4 MM/2.7 MM Variable Angle LCP Forefoot/Midfoot SystemSynthes (Usa)2010228—
+4K100618Maxlock Extreme Extremity Plating System with Variable Angle TechnologyOrthohelix Surgical Designs, Inc.2010339—
+4K033740Lorenz Sternal Closure SystemWalter Lorenz Surgical, Inc.2003100—
+5K261892ProRib Fixation SystemCosta Surgical, Inc.20260—
+5K254053APS Spear Locking PlateA Plus Biotechnology Co., Ltd.20260—