510(k) Report

Devices descending from K963798

756 later devices reach Synthes Titanium Alloy Volar Distal Radius Plate (TI Alloy VDRP) System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+11K250494The OsteoCentric Bone Plate and Screw SystemOsteoCentric Technologies20251—
+11K241563Extremity Medical External Fixation SystemExtremity Medical, LLC20251—
+11K241769Response Ortho Metaphyseal Hinge Fixator SystemResponse Ortho Solutions, LLC20240—
+11K240613APTUS Elbow Dorsal Olecranon PlatesMedartis AG20244—
+11K233873XLO Brand of Locking Distal Humerus Plating SystemOrtho Life Systems Private Limited20240—
+11K230946Accelerate Compression Screw System-Small Product Code ACC-S; Accelerate Compression…Trax Surgical20230—
+11K231461Smart Correction System (HA Half Pins)Wishbone Medical, Inc.20231—
+11K230141LOQTEQ® VA Elbow Plates 2.7/3.5 SystemAap Implantate AG20230—
+11K223786Orthex External Fixation SystemOrthoPediatrics Corp.20232—
+11K222665Medline UNITE® Ankle Fusion Plating SystemMedline Industries, Inc.20230—
+11K222799Haymaker® Screw SystemOrthocircle Spine D.B.A. OC Medical Devices20230—
+11K222820BRM TOOL Screws, BIOPLAN Subtalar ImplantBrm Extremities20220—
+11K222967Avanti Orthopaedics 2.2mm and 2.7mm Cannulated Screws, Avanti Orthopaedics 3.2mm and…Avanti Orthopaedics, Inc.20221—
+11K222282HEMC BRAND Locking Bone Plates and Screws Osteosynthesis Plating SystemHospital Equipment Manufacturing Company20221—
+11K213014Varixis Elbow SystemAuxein Medical Private Limited20220—
+11K222409CAPTIVATE® Compression ScrewsGlobus Medical, Inc.20221—
+11K221792Acute QC Strut and ComponentsSmith & Nephew, Inc.20220—
+11K221366Smart Correction System Rings and Compatible HA-Coated Half PinsWishbone Medical, Inc.20221—
+11K220892ExsoMed INnate NanoTM Lag Screw SystemExsomed Corp.20220—
+11K211650The Radian MIS Bunion SystemNvision Biomedical Technologies, Inc.20213—
+11K212640Stratum® Ankle Fusion Plating SystemNextremity Solutions, Inc.20210—
+11K213036Treace Medical Concepts (TMC) Screw Fixation SystemTreace Medical Concepts, Inc.20217—
+11K212552Correx SoftwareVilex, LLC20210—
+11K210490ChM 4.5mm Cortical screwsChm Sp. Z O.O.20210—
+11K211435PAO Cortical ScrewMedacta International S.A.20210—
+11K203408Summit Patella Plating SystemEndeavor Orthopaedics, LLC20210—
+11K211261Axis Charcot Fixation SystemExtremity Medical, LLC20210—
+11K211313MAXFRAME Multi-Axial Correction System (aka MAXFRAME)Synthes (USA) Products, LLC20212—
+11K210247OsteoCentric Integrated Hip Fastener SystemOsteocentric Technologies D.B.A. Osteocentric Trauma20211—
+11K210408DePuy Synthes Variable Angle Locking Patella Plating SystemSynthes (USA) Products, LLC20211—
+11K210268LTJ Screws and WasherAzurmeds, Inc.20210—
+11K203479ExtremiLOCK Lateral Ankle Fusion PlatesOsteomed20210—
+11K202657Javelin Tailor's Bunion Fixation SystemNvision Biomedical Technologies, Inc.20201—
+11K202764Ortho Solutions Plating SystemOrtho Solutions UK, Ltd.20201—
+11K202307Activ FuseNewclip Technics20200—
+11K203011Monster Screw SystemParagon 28, Inc.20206—
+11K200123Accessories for the SixFix® Hexapod FixatorArrowhead De, LLC20200—
+11K202054Dynex Ring Fixation System, Diametrix Ring Fixation SystemVilex, LLC20201—
+11K200398AxSOS 3 AF System and AxSOS 3 Ti SystemStryker GmbH20209—
+11K200367Distal Humerus Plating SystemSkeletal Dynamics, Inc.20201—
+11K191793Nebula Brand Locking Bone Plates and Screws Osteosynthesis Plating System, Nebula Brand…Nebula Surgical Private Limited20193—
+11K192745DePuy Synthes Trauma ScrewsSynthes (Usa) Products, LLC / Depuy Orthopaedics, Inc.20195—
+11K191636APTUS Foot SystemMedartis AG20190—
+11K190722TriMAX Implant SystemCrossroads Extemity Systems, LLC20190—
+11K191241AutoStrutOrthospin20194—
+11K183363Treace Medical Concepts (TMC) Snap-Off Screw SystemTreace Medical Concepts, Inc.20191—
+11K182677DynaNail MiniMedShape, Inc.20195—
+11K182991EPIC Extremity Fusion Plate SystemEpic Extremity, LLC20190—
+11K182989AURORA™ Screw SystemMiRus, LLC20180—
+11K180541DePuy Synthes 2.0 mm Quick Insertion ScrewsSynthes USA Products, LLC20188—
+11K181091AxSOS 3 TiStryker GmbH201811—
+11K182148SILVERBACK Gorilla Plating SystemParagon 28, Inc.20183—
+11K173883External Fixation SystemLife Spine, Inc.20180—
+11K180024SALVATION Midfoot NailWrightmedicaltechnologyinc20182—
+11K172698G-Beam Fusion Beaming SystemOrthofix Srl20180—
+11K173652Piccolo Composite Nailing SystemCarboFix Orthopedics, Ltd.20170—
+11K172213MECRON Cannulated Screw SystemMerete GmbH20170—
+11K171651Excelsius GPSGlobus Medical, Inc.2017691
+11K171018Axis Charcot Fixation System, 4.5 to 8.5mm Screw SystemExtremity Medical, LLC201724—
+11K163593Additive Orthopaedics Bunion SystemAdditive Orthopaedics, LLC20170—
+11K163650ORTHOLOC® 3Di Ankle Fusion Plating System Line ExtensionWrightmedicaltechnologyinc201712—
+11K161616DePuy Synthes 4.0 mm and 4.5 mm Cortex Screws, DePuy Synthes 2.4 mm Cannulated Screws…Synthes USA Products, LLC201733—
+11K152289Alians Elbow Locking Plating SystemNewclip Technics20166—
+11K153374CARE BRAND Locking Bone Plates and Screws Osteosynthesis Plating System, CARE Brand of…Orthocare20161—
+11K153638Bicortical Fixation Screw & Washer Nut SystemFirst Ray, LLC20160—
+11K160191Align Anterior Ankle Fusion PlateExtremity Medical, LLC20165—
+11K153536Piccolo Composite® Nailing SystemCarboFix Orthopedics, Ltd.201611
+11K152548AXI+LINE Proximal Bunion Correction SystemNextremity Solutions, Inc.20150—
+11K153378Monster BITE Screw SystemParagon 28201522—
+11K150561NET Brand Small Fragment and Large Fragment Osteosynthesis Plating System, NET Brand of…Narang Medical Limited20151—
+11K151057WASTON Metallic Bone Plate and Screw SystemsChangzhou Waston Medical Appliance Co., Ltd.20150—
+11K150871ForeFoot STP SystemTornier, Inc.20150—
+11K150981SMV Scientific Bone ScrewsSmv Scientific20156—
+11K143702Arthrex Blunt Tip Screws with Fiber TapeArthrex, Inc.20154—
+11K143385Acumed Ankle Plating SystemAcumed, LLC201523—
+11K143061Activ Ankle Locking Plating SystemNewclip Technics20158—
+11K143125Orthofix True Lok Hexapod System VI.3Orthofix Srl201426—
+11K141992Variax 2 SystemStryker Trauma AG201422—
+11K140397Paralock Plating System / Tuffnek ScrewParagon 28201431—
+11K122489Emerge Medical Solid Bone ScrewsEmerge Medical20121—
+12K262067iFuse Granite Onyx™ Implant SystemSI-BONE, Inc.20260—
+12K260995DynaNail Helix® Fixation SystemMedShape, Inc.20260—
+12K261647Tempo Plating System; Ultra Compression Screw SystemPace Surgical20260—
+12K261191Alians Elbow SNewclip Technics20260—
+12K254087MAXFRAME AUTOSTRUT™ with Bluetooth Multi-Axial Correction SystemSynthes (USA) Products, LLC20260—
+12K260900DYNEX® External Fixation SystemsVilex, LLC20260—
+12K252699CoAptix S SystemUniversity of Utah, Department of Orthopaedics20260—
+12K253718enHAnce PEEK Bunion SystemNvision Biomedical Technologies, Inc.20261—
+12K260291Vortex5 Tailor's Bunion Correction SystemNvision Biomedical Technologies, Inc.20260—
+12K254110DynaNail Mini; DynaNail Hybrid; DynaNail Helix; DynaClip; DynaClip Forte; DynaClip…MedShape, Inc.20261—
+12K254148VERTICALE GPS InstrumentsSilony Medical GmbH20260—
+12K253488iFuse INTRA Ti™ Implant SystemSI-BONE, Inc.20260—
+12K253423ToeJack MIS Bunion SystemNvision Biomedical Technologies, Inc.20250—
+12K251555Ultra™ Compression Screw SystemPace Surgical20251—
+12K251780iGPS Navigation InstrumentsSI-BONE, Inc.20250—
+12K250867Dunamis Screw and Suture Locking SystemDunamis Medical, LLC20250—
+12K251073Innovasis Navigation Instruments (Vector G-E Navigation Instruments and the Excella G-E…Innovasis, Inc.202501
+12K241525ExcelsiusXR™Globus Medical, Inc.20250—
+12K243326Dynamis Robotic Surgical SystemLEM Surgical AG20251—
+12K243943TriMed® Compression ScrewsTriMed, Inc.20252—