510(k) Report

Devices descending from K944561

450 later devices reach Micro Osteosynthesis System (1.0) through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K241314KLS Martin Oral-Max Implants MR Conditional (bundled)KLS-Martin L.P.20241—
+1K112557Stryker Universal Neuro 3 SystemStryker20129—
+1K082757Modified Sterile Plate & Screw Kit Configurations for Use with Bioplate Titanium…Bioplate, Inc.200801
+1K060177KLS Martin Rigid Fixation - SterileKLS Martin L.P.200665—
+1K040598KLS Martin Hand Plating SystemKLS-Martin L.P.2004360—
+1K032520Ortrautek Trauma SystemTekka20030—
+1K031989Ortrautek Orthognathic SystemTekka20035—
+1K023665Modification to Bioplate Rigid Bone Plating System for Craniomaxillofacial SurgeryBioplate, Inc.20020—
+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—
+2K260137KLS Martin IPS Oral-Max Implants - MR Conditional; Individual Patient Solutions - Ti…KLS-Martin L.P.20260—
+2K252573KLS Martin Cranial Implants - MR Conditional; K944565: KLS-Martin Micro Osteosynthesis…KLS-Martin L.P.20250—
+2K241018KLS Martin Orthopedic Implants - MR ConditionalKLS-Martin L.P.20241—
+2K192162NeuroVention Cranial Fixation System, NuCrani Plates, KTC Burr Hole Cover, DC PlateNeurovention, LLC20200—
+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
+2K123562Flower Small and Medium Bone ImplantsFlower Orthopedics Corporation2013142
+2K120352Stryker Quikflap Sterile Procedure PackStryker2012418
+2K091812Frontier Devices Craniomaxillofacial, Cranio Closure, Orthognathic, Mandible…Frontier Devices, Inc.20104—
+2K070169KLS Martin Quick Disc, Sternal Talon and Sternal Plating - SterileKLS Martin L.P.200761—
+2K062819Bioplate Rigid Bone Plating System for Craniomaxillofacial SurgeryBioplate, Inc.20063—
+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—
+2K023810Modification to Bioplate Rigid Fixation Bone Plating System for Craniomaxillofacial…Bioplate, Inc.20021—
+3K250988KLS Martin Pure Pectus SystemKLS-Martin L.P.20250—
+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—
+3K101484Compressyn BandDallen Medical20115—
+3K073006Osteotrans -MX Bioabsorbable Bone Fixation SystemTakiron Co., Ltd.20082—
+3K073624Modular Foot SystemOrthohelix Surgical Designs, Inc.20083421
+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—
+4K181539OSSDSIGN CranioplugOssdsign AB20181—
+4K170697GBR systemSurgident20182—
+4K173710MotoBAND CP Implant SystemCrossroads Extremity Systems, LLC201841
+4K160300MotoBand (TM) CP Implant SystemCrossroads Extremity Systems, LLC20166—
+4K130431Compressyn BandDallen Medical, Inc.20134—
+4K121606Resorb-X GKLS-Martin L.P.20130—
+4K113014Claw II Polyaxial Compression System and Ortholoc 3DSI Locking ScrewsWrightmedicaltechnologyinc20129712
+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—
+5K261892ProRib Fixation SystemCosta Surgical, Inc.20260—
+5K254053APS Spear Locking PlateA Plus Biotechnology Co., Ltd.20260—
+5K253447Montage Flowable Settable, Resorbable Bone Paste (Burr Hole Cover)Orthocon, Inc.20260—
+5K253660KLS Martin Pure Pectus SystemKLS-Martin L.P.20260—
+5K243357CastleLoc Pectus Bar SystemL&K BIOMED Co., Ltd.20252—
+5K233089NeoSpan® Compression Implant SystemIn2bones USA, LLC20240—
+5K233665DePuy Synthes VOLT Mini Fragment Plating System, DePuy Synthes VOLT Small Fragment…DePuy Synthes20244—
+5K240173Treace Medical Systems (TMC) Plating SystemTreace Medical Concepts, Inc.202441
+5K232515Valkyrie Thoracic Fixation SystemJm Longyear Manufacturing, LLC D/B/A Able Medical Devices20230—
+5K230591TriLEAP Plating SystemCrossroads Extremity Systems20231—
+5K223342MotoBAND™ CP Implant System: DynaBunion™ 4D Minimal-incision Bunion System, DynaMET™…Crossroads Extremity Systems, LLC20232—
+5K222367Save GBRDentis Co., Ltd.20230—
+5K221181Treace Medical Concepts (TMC) Plating SystemTreace Medical Concepts, Inc.20237—
+5K220782IdentiTi™ Porous Ti Interbody System, IdentiTi™ NanoTec™ Interbody System, Transcend™…Alphatec Spine, Inc.202236—
+5K200575Truemed Hand, Foot and Ankle Plates SystemTruemed Group, LLC20210—
+5K211695Valkyrie Thoracic Fixation SystemJm Longyear Manufacturing, LLC D/B/A Able Medical Devices20211—
+5K200062Foot and Ankle SystemLeith Medical, LLC20210—
+5K201578DePuy Synthes Variable Angle Locking Patella Plating SystemSynthes (USA) Products, LLC20203—
+5K182759BoniPlus Dental G-Mesh SystemMontjade Engineering Co., Ltd.20200—
+5K200513DAC Dynamic Active Compression PlatePioneer Surgical Technology, Inc., Dba Rti Surgical20200—
+5K193452MotoBAND CP Implant SystemCrossroads Extemity Systems, LLC20203—
+5K182718Mini and Micro Fragments Reconstruction System – GMReisGm Dos Reis Industria E Comerico Ltda.20194—
+5K190992OrthoPediatrics PediFoot Deformity Corrections SystemOrthoPediatrics Corp.20190—
+5K180554ANTHEM Fracture SystemGlobus Medical, Inc.201810—
+5K182015Piccolo Composite® Plate SystemCarboFix Orthopedics, Ltd.20181—
+5K160553DePuy Synthes 4.0 mm and 5.0 mm Locking Screws – MR Conditional, DePuy Synthes Wrist…Synthes (Usa) Products, LLC / Depuy Orthopaedics, Inc.20170—
+5K162674BioPro Foot Plating SystemsBiopro, Inc.201719—
+5K170401Piccolo Composite® Plate SystemCarboFix Orthopedics, Ltd.20173—
+5K163383GREENS BRAND Locking Bone Plates and Screws Osteosynthesis Plating System, GREENS BRAND…Greens Surgicals Pvt., Ltd.20173—
+5K161894SurgTech Trauma SystemSurgtech, Inc.20173—
+5K142581APTUS Foot SystemMedartis AG201522—
+5K141527Depuy Synthes Variable Angle Locking Hand SystemSynthes USA20157—
+5K150099Depuy Synthes Variable Angle Locking Hand System (1.3 mm and 2.0 mm Plates and Screws)Synthes (USA) Products, LLC201514—
+5K141004Intraosseous Fixation SystemOrthohelix Surgical Designs, Inc.20140—
+5K141784Ortho Solutions Ultos Plating SystemOrtho Solutions Limited2014282
+5K140397Paralock Plating System / Tuffnek ScrewParagon 28201431—
+5K140376Variax 2 SystemStryker Trauma AG201423—