510(k) Report

Devices descending from K050932

606 later devices reach Distal Volar Radius Anatomical Plate System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+4K251161ANTHEM® Fracture SystemGlobus Medical, Inc.20250—
+4K251913OsteoCentric® UnifiMI® TCS Plating SystemOsteoCentric Technologies20250—
+4K250620KLS Martin Ixos SystemKLS Martin L.P.20250—
+4K251945TriMed Total Wrist Fusion System (Total Wrist Fusion Plate)TriMed, Inc.20251—
+4K250155Xpert KneeNewclip Technics20250—
+4K241666EVOS Pelvic and Acetabular SystemSmith & Nephew20250—
+4K242939ARTFX Trauma Bone Plate and Screw SystemArtfx Medical20242—
+4K242995OIC Small / Mini Fragment Plate SystemThe Orthopaedic Implant Company20240—
+4K240487EVOS Patella PlatesSmith & Nephew20240—
+4K241387CoLink NeoFuse MIS Plating System (see attached parts list)In2bones USA20240—
+4K242055Freefix Forearm Plating SystemSkeletal Dynamics, Inc.20240—
+4K233919VariAx 2 Distal Radius SystemStryker GmbH20242—
+4K231292TAMINA 3.5mm Proximal Humerus System; POYA 3.5MM Lateral Proximal Tibia System; LORRAINE…Bonebridge AG20237—
+4K221150Advanced Bone PlateDouble Medical Technology, Inc.20231—
+4K213123EVOS Wrist Spanning PlateSmith & Nephew, Inc.20220—
+4K213864Bonebridge Osteosynthesis Plating SystemBonebridge AG20228—
+4K210935I.T.S. Pelvic Reconstruction System (PRS RX & PRS Phoenix)I.T.S. GmbH202231
+4K220937Arthrex Mini Fragment SystemArthrex, Inc.20222—
+4K213698CoLink PCR Plating SystemIn2bones USA, LLC20220—
+4K213572JuniOrtho Plating System™Orthofix Srl20220—
+4K213069CoLink NeoFuse Plating SystemIn2bones USA, LLC20211—
+4K211051DePuy Synthes 2.7mm Straight and 2.7mm Adaption Plates (Modular Mini Fragment LCP System)DePuy Synthes20211—
+4K210157SOLE Medial Column Fusion PlateOrthofix Srl20210—
+4K202496ANTHEM Fracture SystemGlobus Medical, Inc.20208—
+4K201527EVOS Straight Proximal Humerus 7-15 hole Plates (137-225mm)Smith & Nephew, Inc.20208—
+4K200246JPS JuniOrtho Plating SystemOrthofix Srl20201—
+4K191118Avanti Distal Radius and Forearm SystemAvanti Orthopaedics, Inc.20191—
+4K190391TDM Plate and Screw SystemsTdm Co., Ltd.20191—
+4K192181PRECICE Plating SystemNuvasive Specialized Orthopedics, Inc.201921
+4K191412VariAx 2 System, VariAx 2 Mini Fragment SystemStryker GmbH201910—
+4K190253EVOS Small Fragment Upper Extremity Plates Line AdditionsSmith & Nephew, Inc.20199—
+4K182810Distal Radius Plating SystemMiami Device Solutions, LLC20180—
+4K180554ANTHEM Fracture SystemGlobus Medical, Inc.201810—
+4K173556Injection ScrewBiedermann Medtech, Inc.20180—
+4K181113CoLink™ Afx Plating SystemIn2bones USA, LLC201814—
+4K173746Activmotion RangeNewclip Technics20181—
+4K170704The Locking Pediatric Osteotomy Plate (LolliPOP) SystemPega Medical, Inc.20170—
+4K172262EVOS Small Fragment Plating SystemSmith & Nephew, Inc.20179—
+4K162153Integra® CAPTURE™ Screw System & Integra® Ti6® Internal Fixation SystemAscension Orthopedics20171—
+4K160553DePuy Synthes 4.0 mm and 5.0 mm Locking Screws – MR Conditional, DePuy Synthes Wrist…Synthes (Usa) Products, LLC / Depuy Orthopaedics, Inc.20170—
+4K162674BioPro Foot Plating SystemsBiopro, Inc.201719—
+4K170310Alians Clavicle rangeNewclip Technics20170—
+4K162124Synthes 4.5mm VA-LCP Curved Condylar Plate System Line Extension, Variable Angle…DePuy Synthes20176—
+4K162898Olecranon Plating SystemMiami Device Solutions, LLC20171—
+4K163489OrthoSolutions 'System26' Bone ScrewsOrtho Solutions UK Limited201731
+4K162841VariAx Distal Radius Plating System, VariAx 2 SystemStryker GmbH20174—
+4K161904GEO Bone Screw SystemGramercy Extremity Orthopeidics, LLC20174—
+4K163086VLP MINI-MOD 2.0mm Column PlatesSmith & Nephew, Inc.20160—
+4K162635Distal Radius Plating SystemMiami Device Solutions, LLC20162—
+4K162307OrthoPediatrics Locking Proximal Femur System Cortical ScrewsOrthoPediatrics Corp.20161—
+4K153379AxSOS 3TiStryker GmbH201625—
+4K161041OsteoMed ExtremiLOCK Wrist Plating SystemOsteomed20160—
+4K152242G3¿ Active Plate® Large Fragment SystemGenesis Fracture Care, Inc.20151—
+4K152976VLP Mini-Mod Talus PlatesSmith & Nephew, Inc.20158—
+4K151407RECON systemNormed Medizin-Technik GmbH20154—
+4K150889Suture Wires and Wire LoopsZimmer, Inc.20152—
+4K150626Rush Medullary PinsZimmer, Inc.20150—
+4K150649G3 Active Plate Large Fragment SystemGenesis Fracture Care, Inc.20152—
+4K141527Depuy Synthes Variable Angle Locking Hand SystemSynthes USA20157—
+4K143039CrossRoads Screw SystemOrthodiscovery Group, LLC (D.B.A. Crossroads Extrem201579—
+4K142502Alians Ulna Locking Plating SystemNewclip Technics20142—
+4K143050VLP Mini-Mod Small Bone Plating System 1.5mm Plates and ScrewsSmith & Nephew, Inc.20148—
+4K140792Salvation 3DI Plating SystemWrightmedicaltechnologyinc201421
+4K140408Salvation Osteopenic ScrewWrightmedicaltechnologyinc20141—
+4K133930Flower Rear Foot Plating Set, Flower Calcaneus Planting Set, Flower Rearfoot Plating SetFlower Orthopedics Corporation201406
+4K132774Piccolo Composite Nailing SystemCarboFix Orthopedics, Ltd.20133—
+4K131722I.T.S. Extremity Fixation SystemsI.T.S. GmbH2013242
+4K130774Universal Distal Radius SystemNewclip Technics20135—
+4K130479Ilizarov Drill Tip WiresSmith & Nephew, Inc.20136—
+4K124027Monster Screw SystemApogee Orthosolutions201341—
+4K122334Checkmate Small Bone Fusion SystemArthrosurface, Inc.20125—
+4K122538Acumed Pelvic Bone Plate SystemAcumed, LLC201241
+4K113405Suspension Clavicle Fracture Repair SystemSuspension Orthopaedic Solutions, LLC20120—
+4K112923Suspension Clavicle Fracture Fixation SystemSuspension Orthopaedic Solutions, LLC20110—
+4K112509Trimed Clavicle Fixation SystemTriMed, Inc.20111—
+4K111994Smith & Nephew Cannulated Screws and WashersSmith & Nephew, Inc.2011161—
+4K110670VLP Foot Talus Plates, VLP Percutaneous Calcaneus Plates and Misc VLP Bone Screws…Smith & Nephew, Inc.201169—
+4K093047Smith & Nephew Circular Fixation SystemSmith & Nephew, Inc.2010511
+4K100776Synthes 2.4 MM/2.7 MM Variable Angle LCP Forefoot/Midfoot SystemSynthes (Usa)2010228—
+5K261830FRAXION 3.5 Plate System (Various - See Catalog);FRAXION 4.5 Plate System (Various - See…Ortler Global Tibbi Gerecler Anonim Sirketi20260—
+5K260277Mikron Trauma Bone Plate& Screw SystemMikron Makina San. ve Tic. Ltd. Sti.20260—
+5K262032TriMed Non-Spanning Wrist Fusion Plates (NSFL-STD);TriMed Non-Spanning Wrist Fusion…TriMed, Inc.20260—
+5K261154CoLink® & CoLag® Non-Sterile ScrewsIn2Bones USA, LLC20260—
+5K261145Avanti Distal Elbow ORIF SystemAvanti Orthopaedics, LLC20260—
+5K260228POYA 3.5mm Medial Proximal Tibia SystemBonebridge AG20260—
+5K253906Xpert HandNewclip Technics20260—
+5K254054VOLT™ Ankle Trauma 2.7/3.5 Plating System; VOLT™ Calcaneus 2.7 Plating SystemSynthes GmbH20260—
+5K251892MAXXOS P.A.C.E. Foot & Ankle Plating SystemMaxxos Medical GmbH20250—
+5K250933LORRAINE 2.5/3.5mm Distal Humerus SystemBonebridge AG20251—
+5K241128TDM Plate and Screw SystemTdm Co., Ltd.20240—
+5K242348Locking Screw,CoCrMoDouble Medical Technology, Inc.20240—
+5K242814Tandry Q-Locking Plate SystemMicroware Precision Co., Ltd.20240—
+5K242399Bonebridge Osteosynthesis Plating SystemBonebridge AG20241—
+5K242343BPS Wrist Fracture SystemOrthonovis, Inc.20241—
+5K233816REDEMPTION Charcot Plating SystemVilex, LLC20240—
+5K240318SITTER 3.5mm Versatile SystemBonebridge AG20244—
+5K241539Activmotion SNewclip Technics20240—
+5K234059Forma Medical Optimal Plating SystemForma Medical, Inc.20240—
+5K233665DePuy Synthes VOLT Mini Fragment Plating System, DePuy Synthes VOLT Small Fragment…DePuy Synthes20244—
+5K230591TriLEAP Plating SystemCrossroads Extremity Systems20231—