510(k) Report

Devices descending from K032705

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

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+7K261481Pangea Femur Reconstruction SystemStryker GmbH20260—
+7K260274Airlock® Ankle Plating SystemNovastep SAS20260—
+7K260390Super Upper Limbs Versalock Plating SystemGM Dos Reis Industria e Comercio Ltda.20261—
+7K254093DePuy Synthes VOLT™ Medial Distal Femur 3.5 Plating SystemSynthes GmbH20260—
+7K260069DePuy Synthes VOLT™ Proximal Tibia 3.5 Plating SystemSynthes GmbH20260—
+7K253764ENOS Software Guided External Fixation SystemDisior, Ltd.20260—
+7K253640T2 Alpha Femur Retrograde Nailing System; Pangea Femur Reconstruction SystemStryker GmbH20261—
+7K253291Excelsior SystemBlue Ocean Global20260—
+7K253178TRILEAP Plating SystemCrossroads Extremity Systems20260—
+7K253202Hoffmann LRF SystemStryker GmbH20250—
+7K252191BRUSIO Trauma Toolbox System; TAMINA 3.5mm Proximal Humerus SystemBonebridge AG20250—
+7K252625The Response Ortho Smart Fixator - Hexapod SystemResponse Ortho Solutions, LLC20250—
+7K250163T2 Alpha Femur Retrograde Nailing SystemStryker GmbH20252—
+7K250472SixFix™ Hexapod Fixator and Deformity Analysis and Correction Software (DACS)Amdt Holdings, Inc.20250—
+7K251361Tyber Medical Distal Radius Plating SystemTyber Medical, LLC20250—
+7K242988Genostis Osteosynthesis SystemGenostis AF20250—
+7K243469SignexOsteonic Co., Ltd.20250—
+7K251128Extremity Medical External Fixation SystemExtremity Medical, LLC20250—
+7K243995Arthrex Humeral Plating System and Cerclage ButtonArthrex, Inc.20251—
+7K250494The OsteoCentric Bone Plate and Screw SystemOsteoCentric Technologies20251—
+7K250498BPS Wrist Fracture SystemOrthonovis, Inc.20250—
+7K241563Extremity Medical External Fixation SystemExtremity Medical, LLC20251—
+7K243308Bonebridge Osteosynthesis Plating System (SALGINA 2.5mm Distal Radius System, CASCELLA…Bonebridge AG20241—
+7K242596Versalock Mini and Micro Plating SystemGM Dos Reis Industria e Comercio Ltda.20242—
+7K242445Pangea Platform; Pangea Femur Plating System; Pangea Humerus Plating System; Pangea…Stryker GmbH20240—
+7K241815Protean Fragment Plating SystemSkeletal Dynamics, Inc.20240—
+7K241769Response Ortho Metaphyseal Hinge Fixator SystemResponse Ortho Solutions, LLC20240—
+7K240613APTUS Elbow Dorsal Olecranon PlatesMedartis AG20244—
+7K233873XLO Brand of Locking Distal Humerus Plating SystemOrtho Life Systems Private Limited20240—
+7K231684Quick - Radius Disposable SetGM Dos Reis Industria e Comercio Ltda.20240—
+7K232652Anatomical Plating System (various)Tyber Medical, LLC2023320
+7K232693Tyber Medical Distal Radius Plating SystemTyber Medical, LLC20231—
+7K230946Accelerate Compression Screw System-Small Product Code ACC-S; Accelerate Compression…Trax Surgical20230—
+7K231461Smart Correction System (HA Half Pins)Wishbone Medical, Inc.20231—
+7K230141LOQTEQ® VA Elbow Plates 2.7/3.5 SystemAap Implantate AG20230—
+7K222465Tyber Medical Anatomical Plating SystemTyber Medical, LLC20239—
+7K230118Bony Trauma Extremity System (BTES) Screw Range, NX NailField Orthopaedics Pty, Ltd.20230—
+7K223786Orthex External Fixation SystemOrthoPediatrics Corp.20232—
+7K222665Medline UNITE® Ankle Fusion Plating SystemMedline Industries, Inc.20230—
+7K222799Haymaker® Screw SystemOrthocircle Spine D.B.A. OC Medical Devices20230—
+7K222820BRM TOOL Screws, BIOPLAN Subtalar ImplantBrm Extremities20220—
+7K222967Avanti Orthopaedics 2.2mm and 2.7mm Cannulated Screws, Avanti Orthopaedics 3.2mm and…Avanti Orthopaedics, Inc.20221—
+7K222282HEMC BRAND Locking Bone Plates and Screws Osteosynthesis Plating SystemHospital Equipment Manufacturing Company20221—
+7K213014Varixis Elbow SystemAuxein Medical Private Limited20220—
+7K222409CAPTIVATE® Compression ScrewsGlobus Medical, Inc.20221—
+7K221792Acute QC Strut and ComponentsSmith & Nephew, Inc.20220—
+7K221366Smart Correction System Rings and Compatible HA-Coated Half PinsWishbone Medical, Inc.20221—
+7K212348ALPHALOK™ Plating SystemVilex, LLC20223—
+7K220892ExsoMed INnate NanoTM Lag Screw SystemExsomed Corp.20220—
+7K220199AFFINITY Proximal Tibia SystemTechfit Digital Surgery, Inc.20220—
+7K211650The Radian MIS Bunion SystemNvision Biomedical Technologies, Inc.20213—
+7K212640Stratum® Ankle Fusion Plating SystemNextremity Solutions, Inc.20210—
+7K213036Treace Medical Concepts (TMC) Screw Fixation SystemTreace Medical Concepts, Inc.20217—
+7K212552Correx SoftwareVilex, LLC20210—
+7K210490ChM 4.5mm Cortical screwsChm Sp. Z O.O.20210—
+7K203817Tyber Medical Anatomical Plating SystemTyber Medical, LLC202110—
+7K211435PAO Cortical ScrewMedacta International S.A.20210—
+7K203408Summit Patella Plating SystemEndeavor Orthopaedics, LLC20210—
+7K211261Axis Charcot Fixation SystemExtremity Medical, LLC20210—
+7K211313MAXFRAME Multi-Axial Correction System (aka MAXFRAME)Synthes (USA) Products, LLC20212—
+7K210247OsteoCentric Integrated Hip Fastener SystemOsteocentric Technologies D.B.A. Osteocentric Trauma20211—
+7K210408DePuy Synthes Variable Angle Locking Patella Plating SystemSynthes (USA) Products, LLC20211—
+7K210268LTJ Screws and WasherAzurmeds, Inc.20210—
+7K203479ExtremiLOCK Lateral Ankle Fusion PlatesOsteomed20210—
+7K202657Javelin Tailor's Bunion Fixation SystemNvision Biomedical Technologies, Inc.20201—
+7K202764Ortho Solutions Plating SystemOrtho Solutions UK, Ltd.20201—
+7K202307Activ FuseNewclip Technics20200—
+7K203011Monster Screw SystemParagon 28, Inc.20206—
+7K200123Accessories for the SixFix® Hexapod FixatorArrowhead De, LLC20200—
+7K202054Dynex Ring Fixation System, Diametrix Ring Fixation SystemVilex, LLC20201—
+7K200398AxSOS 3 AF System and AxSOS 3 Ti SystemStryker GmbH20209—
+7K200367Distal Humerus Plating SystemSkeletal Dynamics, Inc.20201—
+7K193614FINE Osteotomy around the kneeBodycad Laboratories, Inc.20204—
+7K191793Nebula Brand Locking Bone Plates and Screws Osteosynthesis Plating System, Nebula Brand…Nebula Surgical Private Limited20193—
+7K192745DePuy Synthes Trauma ScrewsSynthes (Usa) Products, LLC / Depuy Orthopaedics, Inc.20195—
+7K191636APTUS Foot SystemMedartis AG20190—
+7K190722TriMAX Implant SystemCrossroads Extemity Systems, LLC20190—
+7K191241AutoStrutOrthospin20194—
+7K183363Treace Medical Concepts (TMC) Snap-Off Screw SystemTreace Medical Concepts, Inc.20191—
+7K182677DynaNail MiniMedShape, Inc.20195—
+7K182991EPIC Extremity Fusion Plate SystemEpic Extremity, LLC20190—
+7K182989AURORA™ Screw SystemMiRus, LLC20180—
+7K180541DePuy Synthes 2.0 mm Quick Insertion ScrewsSynthes USA Products, LLC20188—
+7K180310DePuy Synthes Trauma Orthopedic Plates and ScrewsSynthes (Usa) Products, LLC / Depuy Orthopaedics, Inc.20184—
+7K181091AxSOS 3 TiStryker GmbH201811—
+7K182148SILVERBACK Gorilla Plating SystemParagon 28, Inc.20183—
+7K173883External Fixation SystemLife Spine, Inc.20180—
+7K180024SALVATION Midfoot NailWrightmedicaltechnologyinc20182—
+7K171320ARMAR / ARTIS Small Fragment and Calcaneal Plates & MBOSS / FIXION Screws, ARMAR/ ARTIS…Meril Healthcare Pvt., Ltd.20182—
+7K172698G-Beam Fusion Beaming SystemOrthofix Srl20180—
+7K173652Piccolo Composite Nailing SystemCarboFix Orthopedics, Ltd.20170—
+7K172383Arthrosurface Bone ScrewsArthrosurface, Inc.20171—
+7K172213MECRON Cannulated Screw SystemMerete GmbH20170—
+7K171651Excelsius GPSGlobus Medical, Inc.2017691
+7K171018Axis Charcot Fixation System, 4.5 to 8.5mm Screw SystemExtremity Medical, LLC201724—
+7K163593Additive Orthopaedics Bunion SystemAdditive Orthopaedics, LLC20170—
+7K163650ORTHOLOC® 3Di Ankle Fusion Plating System Line ExtensionWrightmedicaltechnologyinc201712—
+7K162391AlignMATE™ Lapidus Arthrodesis SystemArthrosurface, Inc.20170—
+7K161616DePuy Synthes 4.0 mm and 4.5 mm Cortex Screws, DePuy Synthes 2.4 mm Cannulated Screws…Synthes USA Products, LLC201733—
+7K152289Alians Elbow Locking Plating SystemNewclip Technics20166—