510(k) Report

Devices descending from K002775

719 later devices reach Distal Volar Radius Fracture Repair System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+10K230141LOQTEQ® VA Elbow Plates 2.7/3.5 SystemAap Implantate AG20230—
+10K223786Orthex External Fixation SystemOrthoPediatrics Corp.20232—
+10K222799Haymaker® Screw SystemOrthocircle Spine D.B.A. OC Medical Devices20230—
+10K222820BRM TOOL Screws, BIOPLAN Subtalar ImplantBrm Extremities20220—
+10K222967Avanti Orthopaedics 2.2mm and 2.7mm Cannulated Screws, Avanti Orthopaedics 3.2mm and…Avanti Orthopaedics, Inc.20221—
+10K222282HEMC BRAND Locking Bone Plates and Screws Osteosynthesis Plating SystemHospital Equipment Manufacturing Company20221—
+10K213014Varixis Elbow SystemAuxein Medical Private Limited20220—
+10K222409CAPTIVATE® Compression ScrewsGlobus Medical, Inc.20221—
+10K221792Acute QC Strut and ComponentsSmith & Nephew, Inc.20220—
+10K221366Smart Correction System Rings and Compatible HA-Coated Half PinsWishbone Medical, Inc.20221—
+10K220892ExsoMed INnate NanoTM Lag Screw SystemExsomed Corp.20220—
+10K213036Treace Medical Concepts (TMC) Screw Fixation SystemTreace Medical Concepts, Inc.20217—
+10K212552Correx SoftwareVilex, LLC20210—
+10K210490ChM 4.5mm Cortical screwsChm Sp. Z O.O.20210—
+10K211435PAO Cortical ScrewMedacta International S.A.20210—
+10K203408Summit Patella Plating SystemEndeavor Orthopaedics, LLC20210—
+10K211261Axis Charcot Fixation SystemExtremity Medical, LLC20210—
+10K211313MAXFRAME Multi-Axial Correction System (aka MAXFRAME)Synthes (USA) Products, LLC20212—
+10K210247OsteoCentric Integrated Hip Fastener SystemOsteocentric Technologies D.B.A. Osteocentric Trauma20211—
+10K210408DePuy Synthes Variable Angle Locking Patella Plating SystemSynthes (USA) Products, LLC20211—
+10K210268LTJ Screws and WasherAzurmeds, Inc.20210—
+10K203479ExtremiLOCK Lateral Ankle Fusion PlatesOsteomed20210—
+10K202764Ortho Solutions Plating SystemOrtho Solutions UK, Ltd.20201—
+10K202307Activ FuseNewclip Technics20200—
+10K203011Monster Screw SystemParagon 28, Inc.20206—
+10K200123Accessories for the SixFix® Hexapod FixatorArrowhead De, LLC20200—
+10K202054Dynex Ring Fixation System, Diametrix Ring Fixation SystemVilex, LLC20201—
+10K200367Distal Humerus Plating SystemSkeletal Dynamics, Inc.20201—
+10K191793Nebula Brand Locking Bone Plates and Screws Osteosynthesis Plating System, Nebula Brand…Nebula Surgical Private Limited20193—
+10K192745DePuy Synthes Trauma ScrewsSynthes (Usa) Products, LLC / Depuy Orthopaedics, Inc.20195—
+10K191636APTUS Foot SystemMedartis AG20190—
+10K190722TriMAX Implant SystemCrossroads Extemity Systems, LLC20190—
+10K191241AutoStrutOrthospin20194—
+10K183363Treace Medical Concepts (TMC) Snap-Off Screw SystemTreace Medical Concepts, Inc.20191—
+10K182677DynaNail MiniMedShape, Inc.20195—
+10K182991EPIC Extremity Fusion Plate SystemEpic Extremity, LLC20190—
+10K182989AURORA™ Screw SystemMiRus, LLC20180—
+10K180541DePuy Synthes 2.0 mm Quick Insertion ScrewsSynthes USA Products, LLC20188—
+10K180310DePuy Synthes Trauma Orthopedic Plates and ScrewsSynthes (Usa) Products, LLC / Depuy Orthopaedics, Inc.20184—
+10K173883External Fixation SystemLife Spine, Inc.20180—
+10K180024SALVATION Midfoot NailWrightmedicaltechnologyinc20182—
+10K171320ARMAR / ARTIS Small Fragment and Calcaneal Plates & MBOSS / FIXION Screws, ARMAR/ ARTIS…Meril Healthcare Pvt., Ltd.20182—
+10K172698G-Beam Fusion Beaming SystemOrthofix Srl20180—
+10K172213MECRON Cannulated Screw SystemMerete GmbH20170—
+10K171651Excelsius GPSGlobus Medical, Inc.2017691
+10K171018Axis Charcot Fixation System, 4.5 to 8.5mm Screw SystemExtremity Medical, LLC201724—
+10K163650ORTHOLOC® 3Di Ankle Fusion Plating System Line ExtensionWrightmedicaltechnologyinc201712—
+10K161616DePuy Synthes 4.0 mm and 4.5 mm Cortex Screws, DePuy Synthes 2.4 mm Cannulated Screws…Synthes USA Products, LLC201733—
+10K152289Alians Elbow Locking Plating SystemNewclip Technics20166—
+10K153374CARE BRAND Locking Bone Plates and Screws Osteosynthesis Plating System, CARE Brand of…Orthocare20161—
+10K153638Bicortical Fixation Screw & Washer Nut SystemFirst Ray, LLC20160—
+10K152548AXI+LINE Proximal Bunion Correction SystemNextremity Solutions, Inc.20150—
+10K153378Monster BITE Screw SystemParagon 28201522—
+10K150561NET Brand Small Fragment and Large Fragment Osteosynthesis Plating System, NET Brand of…Narang Medical Limited20151—
+10K151057WASTON Metallic Bone Plate and Screw SystemsChangzhou Waston Medical Appliance Co., Ltd.20150—
+10K150871ForeFoot STP SystemTornier, Inc.20150—
+10K150981SMV Scientific Bone ScrewsSmv Scientific20156—
+10K143702Arthrex Blunt Tip Screws with Fiber TapeArthrex, Inc.20154—
+10K143385Acumed Ankle Plating SystemAcumed, LLC201523—
+10K143061Activ Ankle Locking Plating SystemNewclip Technics20158—
+10K143125Orthofix True Lok Hexapod System VI.3Orthofix Srl201426—
+10K141992Variax 2 SystemStryker Trauma AG201422—
+10K133102Flower Ankle Plating SetFlower Orthopedics Corporation20130—
+10K122489Emerge Medical Solid Bone ScrewsEmerge Medical20121—
+11K262067iFuse Granite Onyx™ Implant SystemSI-BONE, Inc.20260—
+11K260995DynaNail Helix® Fixation SystemMedShape, Inc.20260—
+11K261647Tempo Plating System; Ultra Compression Screw SystemPace Surgical20260—
+11K261191Alians Elbow SNewclip Technics20260—
+11K254087MAXFRAME AUTOSTRUT™ with Bluetooth Multi-Axial Correction SystemSynthes (USA) Products, LLC20260—
+11K260900DYNEX® External Fixation SystemsVilex, LLC20260—
+11K252699CoAptix S SystemUniversity of Utah, Department of Orthopaedics20260—
+11K254110DynaNail Mini; DynaNail Hybrid; DynaNail Helix; DynaClip; DynaClip Forte; DynaClip…MedShape, Inc.20261—
+11K260353Arthrex Humeral Plating System (Anatomic Humeral Plate) and Cerclage ButtonArthrex, Inc.20260—
+11K254148VERTICALE GPS InstrumentsSilony Medical GmbH20260—
+11K253488iFuse INTRA Ti™ Implant SystemSI-BONE, Inc.20260—
+11K251555Ultra™ Compression Screw SystemPace Surgical20251—
+11K251780iGPS Navigation InstrumentsSI-BONE, Inc.20250—
+11K250867Dunamis Screw and Suture Locking SystemDunamis Medical, LLC20250—
+11K251073Innovasis Navigation Instruments (Vector G-E Navigation Instruments and the Excella G-E…Innovasis, Inc.202501
+11K241525ExcelsiusXR™Globus Medical, Inc.20250—
+11K243326Dynamis Robotic Surgical SystemLEM Surgical AG20251—
+11K243943TriMed® Compression ScrewsTriMed, Inc.20252—
+11K243514Salvo® Robotic Navigation InstrumentsSpine Wave, Inc.20250—
+11K243798Orthex External Fixation SystemOrthoPediatrics Corp.20251—
+11K241599Signature Osteosynthesis Plate SystemSignature Orthopaedic Pty, Ltd.20250—
+11K243814NuVasive Pulse SystemGlobus Medical, Inc.20250—
+11K243671ExcelsiusGPS® InstrumentsGlobus Medical, Inc.20240—
+11K240160EGPS Navigated InstrumentsAstura Medical20240—
+11K242671Treace Medical Concepts (TMC) Screw Fixation SystemTreace Medical Concepts, Inc.20241—
+11K241504iFuse TORQ TNT™ Implant SystemSI-BONE, Inc.20240—
+11K240721ExcelsiusFlex™Globus Medical, Inc.20240—
+11K240951Invictus Robotic Navigation InstrumentsAlphatec Spine20242—
+11K240568DuraPro™ Oscillating SystemGlobus Medical, Inc.20240—
+11K240703Fine Osteotomy™Bodycad Laboratories, Inc.20240—
+11K231850QUARTEX® Occipito-Cervico-Thoracic Spinal System ExcelsiusGPS® InstrumentsGlobus Medical, Inc.20242—
+11K240173Treace Medical Systems (TMC) Plating SystemTreace Medical Concepts, Inc.202441
+11K233638VERZA™ High Speed DrillsGlobus Medical, Inc.20241—
+11K230507Zimed Distal Medial Tibial Plate and Screw SystemZimed Medikal20240—
+11K231272OSSIOfiber® Pin Product Family, OSSIOfiber® Compression Screw, OSSIOfiber® Trimmable…OSSIO, Ltd.20233—
+11K231494CoreLink Robotic Navigation InstrumentsCorelink, LLC20230—