510(k) Report

Devices descending from K924138

581 later devices reach Osteomed M3 System (SBF System) through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K111176Osteomed Low Profile Neuro Fixation SystemOsteomed LP201112
+1K090522Osteomed Hand Plate and Screw Fixation SystemOsteomed LP200915—
+1K080694Osteomed Modular Locking Fixation SystemOsteomed LP20082—
+1K031659Universal Neuro SystemStryker Instruments200312—
+1K011946The Spin Snap-Off ScrewNew Deal, S.A.20016—
+1K962233Twist-Off ScrewLandos, Inc.199692—
+1K962236Scarf Thread-Head ScrewLandos, Inc.1996548—
+2K253108VEOFIX Snap Off ScrewSteps Ortho20260—
+2K210016Integra DigiFuse Cannulated Intramedullary Fusion System,Integra Total Foot…Integra LifeSciences Corporation20210—
+2K200043Field Orthopaedics Bony Trauma Extremity System (BTES) Plate Range and Plate Screws…Field Orthopaedics Pty, Ltd.20201—
+2K182609Delphos Implants Rigid Fixation SystemDelphos Implants - Ind.Com. Importacao E Exportacao DE20190—
+2K163710BePOD® EZ Weil ScrewsFournitures Hospitalieres Industrie20170—
+2K143338Argulated Locking PlatesOsteomed LP20150—
+2K141123Alliance Spine Raas Cranial Plating SystemAlliance Partners, LLC20150—
+2K142658Biomet Headless Compression and Twist-off ScrewsBiomet Manufacturing Corp2014362
+2K132769Acumed Hand Plating SystemAcumed, LLC20147—
+2K120015Osteomed Wrist Plating SystemOsteomed LP20122—
+2K112557Stryker Universal Neuro 3 SystemStryker20129—
+2K111419Osteomed Hand Fusion SystemOsteomed LP20111—
+2K101835Medpor Fixation System-Cranial, Models 80080, 80079Porex Surgical, Inc.20100—
+2K070617Cannulated ScrewFournitures Hospitalieres Industrie20074—
+2K070039Memometal Fixos ScrewsMemometal Technologies200784—
+2K062352FRS ScrewDePuy Orthopaedics, Inc.2006527—
+2K051323Merete Twistcut Snap-Off Bone ScrewMerete Medical GmbH20052—
+3K230118Bony Trauma Extremity System (BTES) Screw Range, NX NailField Orthopaedics Pty, Ltd.20230—
+3K211628MIS Precision Chevron Bunion SystemRelja Innovations, LLC20221—
+3K192162NeuroVention Cranial Fixation System, NuCrani Plates, KTC Burr Hole Cover, DC PlateNeurovention, LLC20200—
+3K190586Monster® Screw SystemParagon 28, Inc.201921—
+3K190035Biomet Headless Compression and Twist-Off ScrewsBiomet, Inc.20194—
+3K180541DePuy Synthes 2.0 mm Quick Insertion ScrewsSynthes USA Products, LLC20188—
+3K170012Foot and Hand MotionNewclip Technics20170—
+3K170040BePOD Cannulated Arthrodesis ScrewsFournitures Hospitalieres Industrie20170—
+3K152187MetaFix LS Locking Screws, Merete Cannulated PCS, Merete CS Cortical Screws, Merete…Merete Medical GmbH20160—
+3K152145OsteoMed ExtremiLOCK Wrist Plating SystemOsteomed20151—
+3K151241Synchro-Medical TIGER TRACK Screw SystemSynchro Medical20150—
+3K151387Stryker Universal Neuro III System: UN III AXS Screw, UN III AXS Screwdriver BladeStryker20152—
+3K150471CalcaNail Orthopedic Arthrodesis NailFournitures Hospitalieres Industrie20150—
+3K150463CalcaNail Orthopedic NailFournitures Hospitalieres Industrie20150—
+3K143146Nexis osteosynthesis snap-off screwsNovastep20152—
+3K143229Nexis osteosynthesis compressive screwsNovastep20153—
+3K1431883.Omm Biomet Cannulated Screw SystemBiomet Manufacturing Corp201481
+3K141383Acumed Hand Fracture SystemAcumed, LLC20146—
+3K131775Universal Neuro 3 SystemStryker20130—
+3K131722I.T.S. Extremity Fixation SystemsI.T.S. GmbH2013242
+3K130120Extremity Medical IP Fusion SystemExtremity Medical, LLC20130—
+3K120352Stryker Quikflap Sterile Procedure PackStryker2012418
+3K120493Mini Cannulated Headed and Headless Screw SetInstratek, Inc.2012391
+3K083912Treu; Bone Screws, Schanz Screws, Kirschner Wires, Steinmann Pins, Larsen PinsTreu-Instrumente GmbH200948—
+3K090675Smith & Nephew, Inc. VLP Foot Plating, Screw System and AccessoriesSmith & Nephew, Inc.2009487—
+4K262075Lapidus Screw KitRelja Innovations, LLC20260—
+4K260958I.T.S. Clavicle Plates with Angular Stability; I.T.S. Volar Radius Plate with Angular…I.T.S. GmbH20260—
+4K252312Eleganz IM Threaded Nail System (IM Threaded Nail System)Dev420250—
+4K233396Cannulated Screw SystemSmith & Nephew, Inc.20230—
+4K223468Nexis® compressive screwsNovastep20230—
+4K230397Cut Screw - Percutaneous Compression ScrewGM Dos Reis Industria e Comercio Ltda.20230—
+4K221150Advanced Bone PlateDouble Medical Technology, Inc.20231—
+4K221090Metal Cannulated ScrewDouble Medical Technology, Inc.20230—
+4K221342REDEMPTION Beaming SystemVilex, LLC20220—
+4K220921Metal Bone ScrewDouble Medical Technology, Inc.20221—
+4K222967Avanti Orthopaedics 2.2mm and 2.7mm Cannulated Screws, Avanti Orthopaedics 3.2mm and…Avanti Orthopaedics, Inc.20221—
+4K213126Smith & Nephew, Inc. Plates and Screws Systems: EVOS, Peri-Loc, D-Rad, TC-100, VLP…Smith & Nephew, Inc.202221
+4K222409CAPTIVATE® Compression ScrewsGlobus Medical, Inc.20221—
+4K210935I.T.S. Pelvic Reconstruction System (PRS RX & PRS Phoenix)I.T.S. GmbH202231
+4K210837Smith & Nephew Plates and ScrewsSmith & Nephew, Inc.202171
+4K211261Axis Charcot Fixation SystemExtremity Medical, LLC20210—
+4K210157SOLE Medial Column Fusion PlateOrthofix Srl20210—
+4K203011Monster Screw SystemParagon 28, Inc.20206—
+4K193214WasherLoc and No-Profile Screw and Washer Systems, Biomet Cannulated Screw System…Biomet, Inc.20203—
+4K202817GEO Bone Screw SystemGramercy Extremity Orthopedics, LLC20201—
+4K200398AxSOS 3 AF System and AxSOS 3 Ti SystemStryker GmbH20209—
+4K192745DePuy Synthes Trauma ScrewsSynthes (Usa) Products, LLC / Depuy Orthopaedics, Inc.20195—
+4K183104Mini Cannulated Headed and Headless Screw SetStryker GmbH20190—
+4K180554ANTHEM Fracture SystemGlobus Medical, Inc.201810—
+4K180808Omni Foot Plating SystemExtremity Medical, LLC20183—
+4K172617Treace Medical Concepts (TMC) Compression Screw SystemTreace Medical Concepts, Inc.201711—
+4K162153Integra® CAPTURE™ Screw System & Integra® Ti6® Internal Fixation SystemAscension Orthopedics20171—
+4K162674BioPro Foot Plating SystemsBiopro, Inc.201719—
+4K171152Stryker Universal Neuro III System AXS ScrewStryker20171—
+4K163489OrthoSolutions 'System26' Bone ScrewsOrtho Solutions UK Limited201731
+4K161894SurgTech Trauma SystemSurgtech, Inc.20173—
+4K161041OsteoMed ExtremiLOCK Wrist Plating SystemOsteomed20160—
+4K150693PHIN-FX Cannulated Lag Screw SystemAscent Medical, LLC20159—
+4K151407RECON systemNormed Medizin-Technik GmbH20154—
+4K143365Eminent Foot Plate SystemEminent Spine20151—
+4K143039CrossRoads Screw SystemOrthodiscovery Group, LLC (D.B.A. Crossroads Extrem201579—
+4K140309CranioplugOssdsign AB20142—
+4K142418I.T.S. Hand Locking Plates System - HLSI.T.S. GmbH201411
+4K132820Vilex Ultima External Fixation System with HA Coated Pins and WiresVilex, Inc.20145—
+4K140792Salvation 3DI Plating SystemWrightmedicaltechnologyinc201421
+4K140408Salvation Osteopenic ScrewWrightmedicaltechnologyinc20141—
+4K140814Evos Mini-Fragment Plating SystemSmith & Nephew, Inc.2014322
+4K133930Flower Rear Foot Plating Set, Flower Calcaneus Planting Set, Flower Rearfoot Plating SetFlower Orthopedics Corporation201406
+4K132886Smith & Nephew Variable-Angle Locking Mini-Fragment Plating SystemSmith & Nephew, Inc.2014462
+4K132248Flower Bone Screw SetFlower Orthopedics Corporation20131—
+4K131264Komet Medical Kirschner Wires, Steinmann Pins and Guide Pins and ScrewsGebr. Brasseler GmbH & Co. KG20131—
+4K130479Ilizarov Drill Tip WiresSmith & Nephew, Inc.20136—
+4K124027Monster Screw SystemApogee Orthosolutions201341—
+4K123890Acumed Cannulated Screw SystemAcumed, LLC2013362
+4K123055Smith & Nephew, Inc Screw and Plate System InstrumentationSmith & Nephew, Inc.201333—
+4K122334Checkmate Small Bone Fusion SystemArthrosurface, Inc.20125—