510(k) Report

Devices descending from K924138

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

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+6K221792Acute QC Strut and ComponentsSmith & Nephew, Inc.20220—
+6K220901S-Core Implant SystemSubchondral Solutions, Inc.20220—
+6K221362Omni Foot and Ankle Plating SystemExremity Medical, LLC20220—
+6K221366Smart Correction System Rings and Compatible HA-Coated Half PinsWishbone Medical, Inc.20221—
+6K213698CoLink PCR Plating SystemIn2bones USA, LLC20220—
+6K212348ALPHALOK™ Plating SystemVilex, LLC20223—
+6K213591ANTHEM® Fracture SystemGlobus Medical, Inc.20225—
+6K212581VariAx 2 Distal Radius System, VariAx 2 Distal Ulna SystemStryker GmbH20224—
+6K213069CoLink NeoFuse Plating SystemIn2bones USA, LLC20211—
+6K212640Stratum® Ankle Fusion Plating SystemNextremity Solutions, Inc.20210—
+6K212552Correx SoftwareVilex, LLC20210—
+6K210490ChM 4.5mm Cortical screwsChm Sp. Z O.O.20210—
+6K203817Tyber Medical Anatomical Plating SystemTyber Medical, LLC202110—
+6K211435PAO Cortical ScrewMedacta International S.A.20210—
+6K203408Summit Patella Plating SystemEndeavor Orthopaedics, LLC20210—
+6K211313MAXFRAME Multi-Axial Correction System (aka MAXFRAME)Synthes (USA) Products, LLC20212—
+6K210247OsteoCentric Integrated Hip Fastener SystemOsteocentric Technologies D.B.A. Osteocentric Trauma20211—
+6K210658Volition Plating SystemOrtho Solutions UK, Ltd.20210—
+6K210408DePuy Synthes Variable Angle Locking Patella Plating SystemSynthes (USA) Products, LLC20211—
+6K210268LTJ Screws and WasherAzurmeds, Inc.20210—
+6K203479ExtremiLOCK Lateral Ankle Fusion PlatesOsteomed20210—
+6K202858Flex-ThreadTM Distal Fibula Intramedullary Nail SystemConventus Orthopaedics, LLC202132
+6K202657Javelin Tailor's Bunion Fixation SystemNvision Biomedical Technologies, Inc.20201—
+6K202764Ortho Solutions Plating SystemOrtho Solutions UK, Ltd.20201—
+6K202307Activ FuseNewclip Technics20200—
+6K201917Piccolo Composite Proximal Tibia Plate SystemCarboFix Orthopedics, Ltd.20200—
+6K200123Accessories for the SixFix® Hexapod FixatorArrowhead De, LLC20200—
+6K201430InFrame™ Cannulated Fixation SystemExsomed Corp.20201—
+6K200367Distal Humerus Plating SystemSkeletal Dynamics, Inc.20201—
+6K193614FINE Osteotomy around the kneeBodycad Laboratories, Inc.20204—
+6K191793Nebula Brand Locking Bone Plates and Screws Osteosynthesis Plating System, Nebula Brand…Nebula Surgical Private Limited20193—
+6K190391TDM Plate and Screw SystemsTdm Co., Ltd.20191—
+6K191636APTUS Foot SystemMedartis AG20190—
+6K190722TriMAX Implant SystemCrossroads Extemity Systems, LLC20190—
+6K191241AutoStrutOrthospin20194—
+6K182677DynaNail MiniMedShape, Inc.20195—
+6K182991EPIC Extremity Fusion Plate SystemEpic Extremity, LLC20190—
+6K182989AURORA™ Screw SystemMiRus, LLC20180—
+6K180310DePuy Synthes Trauma Orthopedic Plates and ScrewsSynthes (Usa) Products, LLC / Depuy Orthopaedics, Inc.20184—
+6K182148SILVERBACK Gorilla Plating SystemParagon 28, Inc.20183—
+6K173883External Fixation SystemLife Spine, Inc.20180—
+6K173556Injection ScrewBiedermann Medtech, Inc.20180—
+6K180024SALVATION Midfoot NailWrightmedicaltechnologyinc20182—
+6K171320ARMAR / ARTIS Small Fragment and Calcaneal Plates & MBOSS / FIXION Screws, ARMAR/ ARTIS…Meril Healthcare Pvt., Ltd.20182—
+6K173746Activmotion RangeNewclip Technics20181—
+6K172698G-Beam Fusion Beaming SystemOrthofix Srl20180—
+6K172383Arthrosurface Bone ScrewsArthrosurface, Inc.20171—
+6K173121Ankle Fusion Plating SystemIn2bones Sas20172—
+6K173166ANTHEM Fracture SystemGlobus Medical, Inc.201711—
+6K171293G3™ Active Plate® Miniature SystemGenesis Fracture Care, Inc.20170—
+6K172213MECRON Cannulated Screw SystemMerete GmbH20170—
+6K171651Excelsius GPSGlobus Medical, Inc.2017691
+6K171018Axis Charcot Fixation System, 4.5 to 8.5mm Screw SystemExtremity Medical, LLC201724—
+6K163593Additive Orthopaedics Bunion SystemAdditive Orthopaedics, LLC20170—
+6K163650ORTHOLOC® 3Di Ankle Fusion Plating System Line ExtensionWrightmedicaltechnologyinc201712—
+6K162898Olecranon Plating SystemMiami Device Solutions, LLC20171—
+6K162391AlignMATE™ Lapidus Arthrodesis SystemArthrosurface, Inc.20170—
+6K162032Arrowhead Mini-Rail FixatorArrowhead De, LLC20171—
+6K161616DePuy Synthes 4.0 mm and 4.5 mm Cortex Screws, DePuy Synthes 2.4 mm Cannulated Screws…Synthes USA Products, LLC201733—
+6K152289Alians Elbow Locking Plating SystemNewclip Technics20166—
+6K153374CARE BRAND Locking Bone Plates and Screws Osteosynthesis Plating System, CARE Brand of…Orthocare20161—
+6K153638Bicortical Fixation Screw & Washer Nut SystemFirst Ray, LLC20160—
+6K160191Align Anterior Ankle Fusion PlateExtremity Medical, LLC20165—
+6K151848Cable-Ready® Cable Grip System: Cable-Ready Pin System, Cable-Ready Needle SystemZimmer, Inc.20161—
+6K153378Monster BITE Screw SystemParagon 28201522—
+6K150561NET Brand Small Fragment and Large Fragment Osteosynthesis Plating System, NET Brand of…Narang Medical Limited20151—
+6K151057WASTON Metallic Bone Plate and Screw SystemsChangzhou Waston Medical Appliance Co., Ltd.20150—
+6K150871ForeFoot STP SystemTornier, Inc.20150—
+6K150981SMV Scientific Bone ScrewsSmv Scientific20156—
+6K143702Arthrex Blunt Tip Screws with Fiber TapeArthrex, Inc.20154—
+6K143385Acumed Ankle Plating SystemAcumed, LLC201523—
+6K143061Activ Ankle Locking Plating SystemNewclip Technics20158—
+6K143125Orthofix True Lok Hexapod System VI.3Orthofix Srl201426—
+6K141992Variax 2 SystemStryker Trauma AG201422—
+6K140397Paralock Plating System / Tuffnek ScrewParagon 28201431—
+6K133102Flower Ankle Plating SetFlower Orthopedics Corporation20130—
+6K122489Emerge Medical Solid Bone ScrewsEmerge Medical20121—
+7K262067iFuse Granite Onyx™ Implant SystemSI-BONE, Inc.20260—
+7K260995DynaNail Helix® Fixation SystemMedShape, Inc.20260—
+7K261271Cable-Ready® Cable Grip SystemPioneer Surgical Technology, Inc.20260—
+7K261191Alians Elbow SNewclip Technics20260—
+7K261351SALGINA 2.5mm Distal Radius SystemBonebridge AG20260—
+7K254087MAXFRAME AUTOSTRUT™ with Bluetooth Multi-Axial Correction SystemSynthes (USA) Products, LLC20260—
+7K260810Anteralign LS coverplateTyber Medical, LLC20260—
+7K260228POYA 3.5mm Medial Proximal Tibia SystemBonebridge AG20260—
+7K252699CoAptix S SystemUniversity of Utah, Department of Orthopaedics20260—
+7K260291Vortex5 Tailor's Bunion Correction SystemNvision Biomedical Technologies, Inc.20260—
+7K254110DynaNail Mini; DynaNail Hybrid; DynaNail Helix; DynaClip; DynaClip Forte; DynaClip…MedShape, Inc.20261—
+7K260361Treace Medical Concepts (TMC) Screw Fixation SystemTreace Medical Concepts, Inc.20260—
+7K260353Arthrex Humeral Plating System (Anatomic Humeral Plate) and Cerclage ButtonArthrex, Inc.20260—
+7K254148VERTICALE GPS InstrumentsSilony Medical GmbH20260—
+7K253488iFuse INTRA Ti™ Implant SystemSI-BONE, Inc.20260—
+7K252106External Fixation Mini Rail SystemParagon 28, Inc.20250—
+7K251780iGPS Navigation InstrumentsSI-BONE, Inc.20250—
+7K251135Treace Medical Concepts (TMC) Implant Fixation SystemTreace Medical Concepts20251—
+7K250867Dunamis Screw and Suture Locking SystemDunamis Medical, LLC20250—
+7K250620KLS Martin Ixos SystemKLS Martin L.P.20250—
+7K251073Innovasis Navigation Instruments (Vector G-E Navigation Instruments and the Excella G-E…Innovasis, Inc.202501
+7K241525ExcelsiusXR™Globus Medical, Inc.20250—
+7K243326Dynamis Robotic Surgical SystemLEM Surgical AG20251—