510(k) Report

Devices descending from K032705

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

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+4K091156Trimed Sterile ProductTriMed, Inc.20090—
+4K090675Smith & Nephew, Inc. VLP Foot Plating, Screw System and AccessoriesSmith & Nephew, Inc.2009487—
+4K063166I.T.S. Pelvic Reconstruction SystemI.T.S. Implantat-Technologie-Systeme GmbH200692
+5K262649Alians ForearmNewclip Technics20260—
+5K260809Arthrex Sterile VAL and VAL KreuLock™ Compression Screw SystemArthrex, Inc.20260—
+5K261207Exalta Proximal Tibia Plating SystemTyber Medical, LLC20260—
+5K260323OrthoPediatrics® Locking Cannulated Blade Plate SystemOrthoPediatrics Corp.20260—
+5K260054I.T.S. PRS Phoenix III.T.S. GmbH20260—
+5K252600Pediatric Plating Platform I Small-MiniOrthoPediatrics Corp.20250—
+5K251161ANTHEM® Fracture SystemGlobus Medical, Inc.20250—
+5K251913OsteoCentric® UnifiMI® TCS Plating SystemOsteoCentric Technologies20250—
+5K250620KLS Martin Ixos SystemKLS Martin L.P.20250—
+5K251945TriMed Total Wrist Fusion System (Total Wrist Fusion Plate)TriMed, Inc.20251—
+5K250155Xpert KneeNewclip Technics20250—
+5K241666EVOS Pelvic and Acetabular SystemSmith & Nephew20250—
+5K242939ARTFX Trauma Bone Plate and Screw SystemArtfx Medical20242—
+5K242995OIC Small / Mini Fragment Plate SystemThe Orthopaedic Implant Company20240—
+5K240487EVOS Patella PlatesSmith & Nephew20240—
+5K241387CoLink NeoFuse MIS Plating System (see attached parts list)In2bones USA20240—
+5K242055Freefix Forearm Plating SystemSkeletal Dynamics, Inc.20240—
+5K233919VariAx 2 Distal Radius SystemStryker GmbH20242—
+5K231292TAMINA 3.5mm Proximal Humerus System; POYA 3.5MM Lateral Proximal Tibia System; LORRAINE…Bonebridge AG20237—
+5K221150Advanced Bone PlateDouble Medical Technology, Inc.20231—
+5K213123EVOS Wrist Spanning PlateSmith & Nephew, Inc.20220—
+5K213864Bonebridge Osteosynthesis Plating SystemBonebridge AG20228—
+5K210935I.T.S. Pelvic Reconstruction System (PRS RX & PRS Phoenix)I.T.S. GmbH202231
+5K220937Arthrex Mini Fragment SystemArthrex, Inc.20222—
+5K213698CoLink PCR Plating SystemIn2bones USA, LLC20220—
+5K213572JuniOrtho Plating System™Orthofix Srl20220—
+5K213069CoLink NeoFuse Plating SystemIn2bones USA, LLC20211—
+5K211051DePuy Synthes 2.7mm Straight and 2.7mm Adaption Plates (Modular Mini Fragment LCP System)DePuy Synthes20211—
+5K210157SOLE Medial Column Fusion PlateOrthofix Srl20210—
+5K202496ANTHEM Fracture SystemGlobus Medical, Inc.20208—
+5K201527EVOS Straight Proximal Humerus 7-15 hole Plates (137-225mm)Smith & Nephew, Inc.20208—
+5K200246JPS JuniOrtho Plating SystemOrthofix Srl20201—
+5K191118Avanti Distal Radius and Forearm SystemAvanti Orthopaedics, Inc.20191—
+5K190391TDM Plate and Screw SystemsTdm Co., Ltd.20191—
+5K192181PRECICE Plating SystemNuvasive Specialized Orthopedics, Inc.201921
+5K191412VariAx 2 System, VariAx 2 Mini Fragment SystemStryker GmbH201910—
+5K190253EVOS Small Fragment Upper Extremity Plates Line AdditionsSmith & Nephew, Inc.20199—
+5K182810Distal Radius Plating SystemMiami Device Solutions, LLC20180—
+5K180554ANTHEM Fracture SystemGlobus Medical, Inc.201810—
+5K173556Injection ScrewBiedermann Medtech, Inc.20180—
+5K181113CoLink™ Afx Plating SystemIn2bones USA, LLC201814—
+5K173746Activmotion RangeNewclip Technics20181—
+5K170704The Locking Pediatric Osteotomy Plate (LolliPOP) SystemPega Medical, Inc.20170—
+5K172262EVOS Small Fragment Plating SystemSmith & Nephew, Inc.20179—
+5K162153Integra® CAPTURE™ Screw System & Integra® Ti6® Internal Fixation SystemAscension Orthopedics20171—
+5K160553DePuy Synthes 4.0 mm and 5.0 mm Locking Screws – MR Conditional, DePuy Synthes Wrist…Synthes (Usa) Products, LLC / Depuy Orthopaedics, Inc.20170—
+5K162674BioPro Foot Plating SystemsBiopro, Inc.201719—
+5K170310Alians Clavicle rangeNewclip Technics20170—
+5K162124Synthes 4.5mm VA-LCP Curved Condylar Plate System Line Extension, Variable Angle…DePuy Synthes20176—
+5K162898Olecranon Plating SystemMiami Device Solutions, LLC20171—
+5K163489OrthoSolutions 'System26' Bone ScrewsOrtho Solutions UK Limited201731
+5K162841VariAx Distal Radius Plating System, VariAx 2 SystemStryker GmbH20174—
+5K161904GEO Bone Screw SystemGramercy Extremity Orthopeidics, LLC20174—
+5K163086VLP MINI-MOD 2.0mm Column PlatesSmith & Nephew, Inc.20160—
+5K162635Distal Radius Plating SystemMiami Device Solutions, LLC20162—
+5K162307OrthoPediatrics Locking Proximal Femur System Cortical ScrewsOrthoPediatrics Corp.20161—
+5K153379AxSOS 3TiStryker GmbH201625—
+5K161041OsteoMed ExtremiLOCK Wrist Plating SystemOsteomed20160—
+5K152242G3¿ Active Plate® Large Fragment SystemGenesis Fracture Care, Inc.20151—
+5K152976VLP Mini-Mod Talus PlatesSmith & Nephew, Inc.20158—
+5K151407RECON systemNormed Medizin-Technik GmbH20154—
+5K150889Suture Wires and Wire LoopsZimmer, Inc.20152—
+5K150626Rush Medullary PinsZimmer, Inc.20150—
+5K150649G3 Active Plate Large Fragment SystemGenesis Fracture Care, Inc.20152—
+5K141527Depuy Synthes Variable Angle Locking Hand SystemSynthes USA20157—
+5K143039CrossRoads Screw SystemOrthodiscovery Group, LLC (D.B.A. Crossroads Extrem201579—
+5K142502Alians Ulna Locking Plating SystemNewclip Technics20142—
+5K143050VLP Mini-Mod Small Bone Plating System 1.5mm Plates and ScrewsSmith & Nephew, Inc.20148—
+5K140792Salvation 3DI Plating SystemWrightmedicaltechnologyinc201421
+5K140408Salvation Osteopenic ScrewWrightmedicaltechnologyinc20141—
+5K133930Flower Rear Foot Plating Set, Flower Calcaneus Planting Set, Flower Rearfoot Plating SetFlower Orthopedics Corporation201406
+5K132774Piccolo Composite Nailing SystemCarboFix Orthopedics, Ltd.20133—
+5K131722I.T.S. Extremity Fixation SystemsI.T.S. GmbH2013242
+5K130774Universal Distal Radius SystemNewclip Technics20135—
+5K130479Ilizarov Drill Tip WiresSmith & Nephew, Inc.20136—
+5K124027Monster Screw SystemApogee Orthosolutions201341—
+5K122334Checkmate Small Bone Fusion SystemArthrosurface, Inc.20125—
+5K122538Acumed Pelvic Bone Plate SystemAcumed, LLC201241
+5K113405Suspension Clavicle Fracture Repair SystemSuspension Orthopaedic Solutions, LLC20120—
+5K112923Suspension Clavicle Fracture Fixation SystemSuspension Orthopaedic Solutions, LLC20110—
+5K112509Trimed Clavicle Fixation SystemTriMed, Inc.20111—
+5K111994Smith & Nephew Cannulated Screws and WashersSmith & Nephew, Inc.2011161—
+5K110670VLP Foot Talus Plates, VLP Percutaneous Calcaneus Plates and Misc VLP Bone Screws…Smith & Nephew, Inc.201169—
+5K093047Smith & Nephew Circular Fixation SystemSmith & Nephew, Inc.2010511
+5K100776Synthes 2.4 MM/2.7 MM Variable Angle LCP Forefoot/Midfoot SystemSynthes (Usa)2010228—
+6K261830FRAXION 3.5 Plate System (Various - See Catalog);FRAXION 4.5 Plate System (Various - See…Ortler Global Tibbi Gerecler Anonim Sirketi20260—
+6K260277Mikron Trauma Bone Plate& Screw SystemMikron Makina San. ve Tic. Ltd. Sti.20260—
+6K262032TriMed Non-Spanning Wrist Fusion Plates (NSFL-STD);TriMed Non-Spanning Wrist Fusion…TriMed, Inc.20260—
+6K261154CoLink® & CoLag® Non-Sterile ScrewsIn2Bones USA, LLC20260—
+6K261145Avanti Distal Elbow ORIF SystemAvanti Orthopaedics, LLC20260—
+6K260228POYA 3.5mm Medial Proximal Tibia SystemBonebridge AG20260—
+6K253906Xpert HandNewclip Technics20260—
+6K254054VOLT™ Ankle Trauma 2.7/3.5 Plating System; VOLT™ Calcaneus 2.7 Plating SystemSynthes GmbH20260—
+6K251892MAXXOS P.A.C.E. Foot & Ankle Plating SystemMaxxos Medical GmbH20250—
+6K250933LORRAINE 2.5/3.5mm Distal Humerus SystemBonebridge AG20251—
+6K241128TDM Plate and Screw SystemTdm Co., Ltd.20240—
+6K242348Locking Screw,CoCrMoDouble Medical Technology, Inc.20240—