510(k) Report

Devices descending from K032705

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

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+6K242814Tandry Q-Locking Plate SystemMicroware Precision Co., Ltd.20240—
+6K242399Bonebridge Osteosynthesis Plating SystemBonebridge AG20241—
+6K242343BPS Wrist Fracture SystemOrthonovis, Inc.20241—
+6K233816REDEMPTION Charcot Plating SystemVilex, LLC20240—
+6K240318SITTER 3.5mm Versatile SystemBonebridge AG20244—
+6K241539Activmotion SNewclip Technics20240—
+6K234059Forma Medical Optimal Plating SystemForma Medical, Inc.20240—
+6K233665DePuy Synthes VOLT Mini Fragment Plating System, DePuy Synthes VOLT Small Fragment…DePuy Synthes20244—
+6K230591TriLEAP Plating SystemCrossroads Extremity Systems20231—
+6K231649Intraosseous Fusion Device SystemAuxano Medical, LLC20230—
+6K230805TriMed Clavicle Fixation SystemTriMed, Inc.20230—
+6K231262Pangea Femur Plating System, Pangea Fibula Plating System, Pangea Tibia Plating System…Stryker GmbH20234—
+6K231257Pangea Utility Plating System, Pangea PlatformStryker GmbH20231—
+6K231333STRETTO™ Cable SystemGlobus Medical, Inc.20230—
+6K222381PeriPRO™ Femur System, Variable Angle Fixation System, AxSOS 3Ti, Stryker Plating SystemStryker GmbH20238—
+6K230053SimpliFix Hip SystemStabiliz Orthopaedics, Inc.20230—
+6K221342REDEMPTION Beaming SystemVilex, LLC20220—
+6K213591ANTHEM® Fracture SystemGlobus Medical, Inc.20225—
+6K203773BRM TOOL ScrewsBrm Extremities Srl20221—
+6K212487CoLink Vallux Plating SystemIn2bones USA, LLC20214—
+6K202326BESPA Charcot SystemBespa Global, LLC20210—
+6K212433Anthem Fracture SystemGlobus Medical, Inc.20217—
+6K210953SMART Taylor Spatial FrameSmith & Nephew, Inc.20212—
+6K210016Integra DigiFuse Cannulated Intramedullary Fusion System,Integra Total Foot…Integra LifeSciences Corporation20210—
+6K211592Avanti Orthopaedics Ulnar Shortening SystemAvanti Orthopaedics, Inc.20211—
+6K200575Truemed Hand, Foot and Ankle Plates SystemTruemed Group, LLC20210—
+6K210060CoLink Mfx Implant SystemIn2bones USA, LLC20211—
+6K200062Foot and Ankle SystemLeith Medical, LLC20210—
+6K202348External Remote Controller ERC 4PNuvasive Specialized Orthopedics, Inc.20200—
+6K201253Modular Rail System, TAYLOR SPATIAL FRAME External Fixator, JET-X Fixator, ILIZAROV…Smith & Nephew20205—
+6K202817GEO Bone Screw SystemGramercy Extremity Orthopedics, LLC20201—
+6K200987LTJ Screws and WasherAzurmeds, Inc.20201—
+6K193368Smart Correction SystemWishbone Medical, Inc.202031
+6K201578DePuy Synthes Variable Angle Locking Patella Plating SystemSynthes (USA) Products, LLC20203—
+6K201149CoLink Plating SystemIn2bones USA, LLC20200—
+6K201556Intraosseous Fixation SystemExtremity Medical, LLC20200—
+6K201430InFrame™ Cannulated Fixation SystemExsomed Corp.20201—
+6K193617Precice® ScrewsNuvasive Specialized Orthopedics, Inc.20200—
+6K200762CoLink Cfx Plating SystemIn2bones USA, LLC20201—
+6K200043Field Orthopaedics Bony Trauma Extremity System (BTES) Plate Range and Plate Screws…Field Orthopaedics Pty, Ltd.20201—
+6K193029Conquest FNSmith & Nephew, Inc.202010—
+6K193222Tyber Medical Anatomical Plating SystemTyber Medical, LLC202011—
+6K193543CoLink Plating System, Fracture and Correction System, CoLink Mini Plating System…In2bones USA, LLC20200—
+6K182718Mini and Micro Fragments Reconstruction System – GMReisGm Dos Reis Industria E Comerico Ltda.20194—
+6K191641AFFINITY – Variable Angle Distal Radius System, AFFINITY – Variable Angle Distal Radius…Industrias Medicas Sampedro S.A.S20193—
+6K191342CrossRoads Screw SystemCrossroads Extemity Systems, LLC20190—
+6K190385CoLink Plating System, Fracture and Correction System, RTS Implant System, NeoSpan…In2bones USA, LLC20190—
+6K190992OrthoPediatrics PediFoot Deformity Corrections SystemOrthoPediatrics Corp.20190—
+6K191535CoLink® Mini Plating SystemIn2bones USA, LLC20196—
+6K190750DePuy Synthes Plates and Screws PortfolioDePuy Synthes20190—
+6K190069SixFix™ Hexapod Fixator and Deformity Analysis and Correction Software (DACS)Arrowhead De, LLC20193—
+6K190586Monster® Screw SystemParagon 28, Inc.201921—
+6K183011Additive Orthopaedics Patient Specific 3D Locking Lattice PlatesAdditive Orthopaedics20195—
+6K180539Deformity Analysis and Correction Software (DACS) and InstrumentationArrowhead Medical Device Technologies, LLC20184—
+6K172975DePuy Synthes (USA) 5.0mm / 7.3mm Crimp Positioning Pins – MR Conditional, DePuy Synthes…Synthes (Usa) Products, LLC / Depuy Orthopaedics, Inc.20182—
+6K172785Conquest FNSmith & Nephew20178—
+6K172350AxSOS 3 TiStryker GmbH201717—
+6K172617Treace Medical Concepts (TMC) Compression Screw SystemTreace Medical Concepts, Inc.201711—
+6K171293G3™ Active Plate® Miniature SystemGenesis Fracture Care, Inc.20170—
+6K162825CAPTIVATE™ Compression ScrewsGlobus Medical, Inc.201774—
+6K163383GREENS BRAND Locking Bone Plates and Screws Osteosynthesis Plating System, GREENS BRAND…Greens Surgicals Pvt., Ltd.20173—
+6K162439AxSOS 3 Ti; Stryker Plating SystemStryker GmbH201724—
+6K1609464.0 and 6.5 Cancellous Bone Screw and WasherSmv Scientific20161—
+6K161417DePuy Synthes MAXFRAME Multi-Axial Correction SystemSynthes USA, LLC20168—
+6K161539Arthrosurface Bone ScrewsArthrosurface, Inc.20162—
+6K151881X-Fix Line AdditionsVilex IN Tennessee, Inc.201672
+6K152686Conquest FNSmith & Nephew201612—
+6K151708RECON system - Compression ScrewsNormed Medizin-Technik GmbH20160—
+6K151848Cable-Ready® Cable Grip System: Cable-Ready Pin System, Cable-Ready Needle SystemZimmer, Inc.20161—
+6K152312RECON system-V-TEK-IVP Plates and ScrewsNormed Medizin-Technik GmbH201524
+6K152072CrossRoads Screw SystemCrossroads Extremity Systems, LLC20153—
+6K151241Synchro-Medical TIGER TRACK Screw SystemSynchro Medical20150—
+6K151010Piccolo Composite Nailing SystemCarboFix Orthopedics, Ltd.201521
+6K151418Monster Screw SystemParagon 28201527—
+6K142581APTUS Foot SystemMedartis AG201522—
+6K143365Eminent Foot Plate SystemEminent Spine20151—
+6K150099Depuy Synthes Variable Angle Locking Hand System (1.3 mm and 2.0 mm Plates and Screws)Synthes (USA) Products, LLC201514—
+6K142520Smith & Nephew, Inc. Spatialframe.com V5.0 Web-based softwareSmith & Nephew, Inc.201431
+6K142442Magna-FX and Mini Magna-FX Cannulated Screw Fixation SystemZimmer, Inc.2014153
+6K142418I.T.S. Hand Locking Plates System - HLSI.T.S. GmbH201411
+6K141078Orthofix TL-Hex True Lok Hexalobe System (TL-Hex)Orthofix Srl201432—
+6K140550Orthohub External Fixator SoftwareOrthohub, Inc.20145—
+6K141784Ortho Solutions Ultos Plating SystemOrtho Solutions Limited2014282
+6K140741Salvation Beams and Bolts SystemWrightmedicaltechnologyinc201434—
+6K140617Pinit Small Bone Fusion SystemArthrosurface, Inc.20144—
+6K140376Variax 2 SystemStryker Trauma AG201423—
+6K123347Normed Ankle Fix System 4.0 and Normed Ankle Fix Plus System 4.0Normed Medizin-Technik GmbH201322
+6K131324Maxtorque Screw SystemOrthohelix Surgical Designs, Inc.20132—
+6K121425Ortholoc 3DI Ankle Fusion Plating SystemWrightmedicaltechnologyinc201253—
+6K121601Synthes 2.7/3.5MM Variable Angle LCP Ankle Trauma System-Anterolateral Distal Tibia PlateSynthes USA20126—
+6K120854Synthes VA LCP Ankle Trauma SystemSynthes USA201244—
+6K120871Smith & Nephew, Inc. External Fixation System InstrumentationSmith & Nephew, Inc.20126—
+6K120717Synthes Variable Angle LCP Elbow System (Medical and Posterolateral Distal Humerus Plates)Synthes USA201253—
+6K120667VLP 2.7MM Extra Large Percutaneous Calcaneus Plate, Peri-Loc 3.5MM Anterior Ankle Fusion…Smith & Nephew, Inc.20129—
+6K120070Synthes Variable Angle LCP Elbow SystemSynthes USA2012761
+6K113762Checkmate Metatarso-Phalangeal (MTP) Arthrodesis SystemArthrosurface, Inc.20121—
+6K112583Synthes Cortical ScrewsSynthes (USA) Products, LLC2011118—
+6K110069Smith & Nephew, Inc Spatialframe V4.1 Web-Based SoftwareSmith & Nephew, Inc.201118—
+7K262537Versalock Sterile Plating SystemGM Dos Reis Industria e Comercio Ltda.20260—
+7K261271Cable-Ready® Cable Grip SystemPioneer Surgical Technology, Inc.20260—