510(k) Report

Devices descending from K023007

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

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+9K253178TRILEAP Plating SystemCrossroads Extremity Systems20260—
+9K253202Hoffmann LRF SystemStryker GmbH20250—
+9K252625The Response Ortho Smart Fixator - Hexapod SystemResponse Ortho Solutions, LLC20250—
+9K250163T2 Alpha Femur Retrograde Nailing SystemStryker GmbH20252—
+9K250472SixFix™ Hexapod Fixator and Deformity Analysis and Correction Software (DACS)Amdt Holdings, Inc.20250—
+9K242988Genostis Osteosynthesis SystemGenostis AF20250—
+9K251128Extremity Medical External Fixation SystemExtremity Medical, LLC20250—
+9K243995Arthrex Humeral Plating System and Cerclage ButtonArthrex, Inc.20251—
+9K250494The OsteoCentric Bone Plate and Screw SystemOsteoCentric Technologies20251—
+9K241563Extremity Medical External Fixation SystemExtremity Medical, LLC20251—
+9K241769Response Ortho Metaphyseal Hinge Fixator SystemResponse Ortho Solutions, LLC20240—
+9K240613APTUS Elbow Dorsal Olecranon PlatesMedartis AG20244—
+9K233873XLO Brand of Locking Distal Humerus Plating SystemOrtho Life Systems Private Limited20240—
+9K230946Accelerate Compression Screw System-Small Product Code ACC-S; Accelerate Compression…Trax Surgical20230—
+9K231461Smart Correction System (HA Half Pins)Wishbone Medical, Inc.20231—
+9K230141LOQTEQ® VA Elbow Plates 2.7/3.5 SystemAap Implantate AG20230—
+9K222465Tyber Medical Anatomical Plating SystemTyber Medical, LLC20239—
+9K223786Orthex External Fixation SystemOrthoPediatrics Corp.20232—
+9K222665Medline UNITE® Ankle Fusion Plating SystemMedline Industries, Inc.20230—
+9K222799Haymaker® Screw SystemOrthocircle Spine D.B.A. OC Medical Devices20230—
+9K222820BRM TOOL Screws, BIOPLAN Subtalar ImplantBrm Extremities20220—
+9K222967Avanti Orthopaedics 2.2mm and 2.7mm Cannulated Screws, Avanti Orthopaedics 3.2mm and…Avanti Orthopaedics, Inc.20221—
+9K222282HEMC BRAND Locking Bone Plates and Screws Osteosynthesis Plating SystemHospital Equipment Manufacturing Company20221—
+9K213014Varixis Elbow SystemAuxein Medical Private Limited20220—
+9K222409CAPTIVATE® Compression ScrewsGlobus Medical, Inc.20221—
+9K221792Acute QC Strut and ComponentsSmith & Nephew, Inc.20220—
+9K221366Smart Correction System Rings and Compatible HA-Coated Half PinsWishbone Medical, Inc.20221—
+9K220892ExsoMed INnate NanoTM Lag Screw SystemExsomed Corp.20220—
+9K211650The Radian MIS Bunion SystemNvision Biomedical Technologies, Inc.20213—
+9K212640Stratum® Ankle Fusion Plating SystemNextremity Solutions, Inc.20210—
+9K213036Treace Medical Concepts (TMC) Screw Fixation SystemTreace Medical Concepts, Inc.20217—
+9K212552Correx SoftwareVilex, LLC20210—
+9K210490ChM 4.5mm Cortical screwsChm Sp. Z O.O.20210—
+9K203817Tyber Medical Anatomical Plating SystemTyber Medical, LLC202110—
+9K211435PAO Cortical ScrewMedacta International S.A.20210—
+9K203408Summit Patella Plating SystemEndeavor Orthopaedics, LLC20210—
+9K211261Axis Charcot Fixation SystemExtremity Medical, LLC20210—
+9K211313MAXFRAME Multi-Axial Correction System (aka MAXFRAME)Synthes (USA) Products, LLC20212—
+9K210247OsteoCentric Integrated Hip Fastener SystemOsteocentric Technologies D.B.A. Osteocentric Trauma20211—
+9K210408DePuy Synthes Variable Angle Locking Patella Plating SystemSynthes (USA) Products, LLC20211—
+9K210268LTJ Screws and WasherAzurmeds, Inc.20210—
+9K203479ExtremiLOCK Lateral Ankle Fusion PlatesOsteomed20210—
+9K202657Javelin Tailor's Bunion Fixation SystemNvision Biomedical Technologies, Inc.20201—
+9K202764Ortho Solutions Plating SystemOrtho Solutions UK, Ltd.20201—
+9K202307Activ FuseNewclip Technics20200—
+9K203011Monster Screw SystemParagon 28, Inc.20206—
+9K200123Accessories for the SixFix® Hexapod FixatorArrowhead De, LLC20200—
+9K202054Dynex Ring Fixation System, Diametrix Ring Fixation SystemVilex, LLC20201—
+9K200398AxSOS 3 AF System and AxSOS 3 Ti SystemStryker GmbH20209—
+9K200367Distal Humerus Plating SystemSkeletal Dynamics, Inc.20201—
+9K193614FINE Osteotomy around the kneeBodycad Laboratories, Inc.20204—
+9K191793Nebula Brand Locking Bone Plates and Screws Osteosynthesis Plating System, Nebula Brand…Nebula Surgical Private Limited20193—
+9K192745DePuy Synthes Trauma ScrewsSynthes (Usa) Products, LLC / Depuy Orthopaedics, Inc.20195—
+9K191636APTUS Foot SystemMedartis AG20190—
+9K190722TriMAX Implant SystemCrossroads Extemity Systems, LLC20190—
+9K191241AutoStrutOrthospin20194—
+9K183363Treace Medical Concepts (TMC) Snap-Off Screw SystemTreace Medical Concepts, Inc.20191—
+9K182677DynaNail MiniMedShape, Inc.20195—
+9K182991EPIC Extremity Fusion Plate SystemEpic Extremity, LLC20190—
+9K182989AURORA™ Screw SystemMiRus, LLC20180—
+9K180541DePuy Synthes 2.0 mm Quick Insertion ScrewsSynthes USA Products, LLC20188—
+9K180310DePuy Synthes Trauma Orthopedic Plates and ScrewsSynthes (Usa) Products, LLC / Depuy Orthopaedics, Inc.20184—
+9K181091AxSOS 3 TiStryker GmbH201811—
+9K182148SILVERBACK Gorilla Plating SystemParagon 28, Inc.20183—
+9K173883External Fixation SystemLife Spine, Inc.20180—
+9K180024SALVATION Midfoot NailWrightmedicaltechnologyinc20182—
+9K171320ARMAR / ARTIS Small Fragment and Calcaneal Plates & MBOSS / FIXION Screws, ARMAR/ ARTIS…Meril Healthcare Pvt., Ltd.20182—
+9K172698G-Beam Fusion Beaming SystemOrthofix Srl20180—
+9K173652Piccolo Composite Nailing SystemCarboFix Orthopedics, Ltd.20170—
+9K172213MECRON Cannulated Screw SystemMerete GmbH20170—
+9K171651Excelsius GPSGlobus Medical, Inc.2017691
+9K171018Axis Charcot Fixation System, 4.5 to 8.5mm Screw SystemExtremity Medical, LLC201724—
+9K163593Additive Orthopaedics Bunion SystemAdditive Orthopaedics, LLC20170—
+9K163650ORTHOLOC® 3Di Ankle Fusion Plating System Line ExtensionWrightmedicaltechnologyinc201712—
+9K161616DePuy Synthes 4.0 mm and 4.5 mm Cortex Screws, DePuy Synthes 2.4 mm Cannulated Screws…Synthes USA Products, LLC201733—
+9K152289Alians Elbow Locking Plating SystemNewclip Technics20166—
+9K153374CARE BRAND Locking Bone Plates and Screws Osteosynthesis Plating System, CARE Brand of…Orthocare20161—
+9K153638Bicortical Fixation Screw & Washer Nut SystemFirst Ray, LLC20160—
+9K160191Align Anterior Ankle Fusion PlateExtremity Medical, LLC20165—
+9K153536Piccolo Composite® Nailing SystemCarboFix Orthopedics, Ltd.201611
+9K152548AXI+LINE Proximal Bunion Correction SystemNextremity Solutions, Inc.20150—
+9K153378Monster BITE Screw SystemParagon 28201522—
+9K150561NET Brand Small Fragment and Large Fragment Osteosynthesis Plating System, NET Brand of…Narang Medical Limited20151—
+9K151057WASTON Metallic Bone Plate and Screw SystemsChangzhou Waston Medical Appliance Co., Ltd.20150—
+9K150871ForeFoot STP SystemTornier, Inc.20150—
+9K150981SMV Scientific Bone ScrewsSmv Scientific20156—
+9K143702Arthrex Blunt Tip Screws with Fiber TapeArthrex, Inc.20154—
+9K143385Acumed Ankle Plating SystemAcumed, LLC201523—
+9K143061Activ Ankle Locking Plating SystemNewclip Technics20158—
+9K143125Orthofix True Lok Hexapod System VI.3Orthofix Srl201426—
+9K141992Variax 2 SystemStryker Trauma AG201422—
+9K140397Paralock Plating System / Tuffnek ScrewParagon 28201431—
+9K133102Flower Ankle Plating SetFlower Orthopedics Corporation20130—
+9K122489Emerge Medical Solid Bone ScrewsEmerge Medical20121—
+10K262067iFuse Granite Onyx™ Implant SystemSI-BONE, Inc.20260—
+10K260995DynaNail Helix® Fixation SystemMedShape, Inc.20260—
+10K261647Tempo Plating System; Ultra Compression Screw SystemPace Surgical20260—
+10K261191Alians Elbow SNewclip Technics20260—
+10K254087MAXFRAME AUTOSTRUT™ with Bluetooth Multi-Axial Correction SystemSynthes (USA) Products, LLC20260—
+10K260810Anteralign LS coverplateTyber Medical, LLC20260—