510(k) Report

Devices descending from K032705

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

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K050932Distal Volar Radius Anatomical Plate SystemHand Innovations, Inc.20056061
+1K042437Dorsal Intramedullary PlateDeo Volente Orthopaedics, LLC20047—
+2K191972ARIX Wrist SystemJeil Medical Corporation20190—
+2K133939Modified Distal Radius Plating SystemBiomet2014112
+2K111663Trauma Internal Fixation SystemsDePuy Orthopaedics, Inc.2012117
+2K090374Sterile DVR Anatomic Plates Various Configurations) Model (S) 131212001,2, 5-10 2.5MM…DePuy Orthopaedics, Inc.200918—
+2K071809Ensplintrx Bone Fixation SystemSonoma Orthopedic Products, Inc.20086—
+2K060864Multidirectional Threaded PegHand Innovations, LLC200618—
+2K051735Peri-Loc Locking Bone Plates and Locking Bone Screws for the Upper ExtremitySmith & Nephew, Inc.2005584—
+3K243761A.L.P.S. Small Fragment Plating SystemBiomet Orthopedics20250—
+3K213126Smith & Nephew, Inc. Plates and Screws Systems: EVOS, Peri-Loc, D-Rad, TC-100, VLP…Smith & Nephew, Inc.202221
+3K210837Smith & Nephew Plates and ScrewsSmith & Nephew, Inc.202171
+3K161665VLP Wrist Fracture SystemSmith & Nephew, Inc.201610—
+3K141493Proximal Humerus Plating SystemMiami Device Solutions201571
+3K140357Oic Variable Angle Small Fragment Locking Plate SystemOrthopaedic Implant Company20142—
+3K132296D-Rad Smart PackSmith & Nephew, Inc.2014114
+3K131636Polarus ConnectAcumed, LLC20130—
+3K123055Smith & Nephew, Inc Screw and Plate System InstrumentationSmith & Nephew, Inc.201333—
+3K102689Conventus Orthopaedics Fracture Fixation SystemConventus Orthopaedics20134—
+3K122737Geminus Fossa Specific Plate SystemSkeletal Dynamics, LLC20123—
+3K120015Osteomed Wrist Plating SystemOsteomed LP20122—
+3K102597Piccolo Composite Plate SystemN.M.B. Medical Applications, Ltd.201115—
+3K100325Peri-Loc Locking Hole Inserts and Cable AccessoriesSmith & Nephew, Inc.201038—
+3K090304Waveon WRX Bone Fixation SystemSonoma Orthopedic Products, Inc.20090—
+3K092015Peri-Loc Periarticular Locked Plating SystemSmith & Nephew, Inc.2009411
+3K083286Orthopediatrics Pediloc Locking Plate SystemOrthoPediatrics Corp.2009605
+3K083032Peri-Loc Bone Plating and Screw SystemSmith & Nephew, Inc.2009772
+3K082516Peri-Loc Periarticular Locked Plating System Hexalobular Bone ScrewsSmith & Nephew, Inc.200887—
+3K081106Peri-Loc Periarticular Locked Plating System Volar Distal Radius Locking Plate for the…Smith & Nephew, Inc.200834—
+3K071563Peri-Loc Periarticular Locked Plating SystemSmith & Nephew, Inc.2007495—
+3K061352Peri-Loc Periarticular Locked Plating System for the Upper ExtremitySmith & Nephew, Inc.2006108—
+3K060156Straight Plate with Angular Stability & Screw SystemI.T.S. Implantat-Technologie-Systeme GmbH2006272
+3K060041Trimed Bone PlatesTriMed, Inc.2006263
+4K260958I.T.S. Clavicle Plates with Angular Stability; I.T.S. Volar Radius Plate with Angular…I.T.S. GmbH20260—
+4K253713Arthrex Variable Angle (VA) Proximal Tibia Plating SystemArthrex, Inc.20260—
+4K252019CurvaFix Low Profile SystemCurvafix, Inc.20250—
+4K243963Pediatric Plating Platform HipOrthoPediatrics Corp.20250—
+4K242973CanMINI Hand and Foot SystemCanwell Medical Co., Ltd.20250—
+4K243987TriMed Elbow and Forearm SystemTriMed, Inc.20251—
+4K243999TriMed Ankle Fixation SystemTriMed, Inc.20252—
+4K242079Arthrex Elbow Fracture Plating SystemArthrex, Inc.20240—
+4K242554Arthrex VAL and VAL KreuLock™ Compression Screw SystemArthrex, Inc.20241—
+4K233396Cannulated Screw SystemSmith & Nephew, Inc.20230—
+4K233017TM Plating SystemTyber Medical, LLC20231—
+4K223118OIC Variable Angle Small Fragment Locking Plate SystemOrthopaedic Implant Company20231—
+4K212581VariAx 2 Distal Radius System, VariAx 2 Distal Ulna SystemStryker GmbH20224—
+4K213214Xpert WristNewclip Technics20210—
+4K203405EVOS Large Fragment Plating SystemSmith & Nephew, Inc.20213—
+4K201918EVOS Large Fragment Plating SystemSmith & Nephew, Inc.202044
+4K201917Piccolo Composite Proximal Tibia Plate SystemCarboFix Orthopedics, Ltd.20200—
+4K200538Skeletal Dynamics Forearm Plating SystemSkeletal Dynamics, Inc.20201—
+4K181843MLP Special Locking Bone Plate SystemMaxxion Medical, LLC / Baumer SA20190—
+4K182015Piccolo Composite® Plate SystemCarboFix Orthopedics, Ltd.20181—
+4K181533EVOS Wrist Fracture Plating SystemSmith & Nephew, Inc.20189—
+4K173293EVOS Small Fragment Upper Extremity PlatesSmith & Nephew, Inc.201812—
+4K172786MDS Plating SystemMiami Device Solutions, LLC20170—
+4K173121Ankle Fusion Plating SystemIn2bones Sas20172—
+4K173166ANTHEM Fracture SystemGlobus Medical, Inc.201711—
+4K170843Alians Fragment SpecificNewclip Technics20171—
+4K170457EVOS Small Fragment Lower Extremity PlatesSmith & Nephew, Inc.2017131
+4K170401Piccolo Composite® Plate SystemCarboFix Orthopedics, Ltd.20173—
+4K170887EVOS Small Fragment Plating SystemSmith & Nephew, Inc.201713—
+4K163361ANTHEM™ Fracture SystemGlobus Medical, Inc.201714—
+4K161894SurgTech Trauma SystemSurgtech, Inc.20173—
+4K162078EVOS Small Fragment Plating SystemSmith & Nephew, Inc.2016261
+4K161292Distal Radius Plating SystemMiami Device Solutions, LLC20164—
+4K161058Cannulated ScrewMiami Device Solutions, LLC20161—
+4K161048Conventus Orthopaedics Ulna Fixation SystemConventus Orthopaedics, Inc.20160—
+4K160995NEOVIEW Plating SystemIn2bones Sas201624
+4K160633G3(TM) Active Plate (R) Small Fragment SystemGenesis Fracture Care, Inc.20160—
+4K160002Piccolo Composite (R) Distal Volar Radius Plate SystemCarboFix Orthopedics, Ltd.20164—
+4K151735TriMed Humeral Supracondylar Fixation SystemTriMed, Inc.20160—
+4K152145OsteoMed ExtremiLOCK Wrist Plating SystemOsteomed20151—
+4K151886Acumed Ankle and Small Fragment Base Set UpdateAcumed, LLC201515—
+4K150693PHIN-FX Cannulated Lag Screw SystemAscent Medical, LLC20159—
+4K151379Conventus PRS SystemConventus Orthopaedics, Inc.20151—
+4K143496Piccolo Composite Plate SystemCarboFix Orthopedics, Ltd.20154—
+4K141737Conventus PHS SystemConventus Orthopaedics, Inc.20150—
+4K142938G3 Active Plate Large Fragment SystemGenesis Fracture Care, Inc.20143—
+4K140431Pediloc Fragment SystemOrthoPediatrics Corp.20141—
+4K141430Variax Distal Radius Plating SystemStryker Leibinger GmbH & Co KG201412—
+4K141121Axsos 3 TI Locking Plate SystemStryker Trauma AG201426—
+4K140814Evos Mini-Fragment Plating SystemSmith & Nephew, Inc.2014322
+4K131552Conventus DRSConventus Orthopaedics20142—
+4K132886Smith & Nephew Variable-Angle Locking Mini-Fragment Plating SystemSmith & Nephew, Inc.2014462
+4K130810Zimmer Motionloc Screw for Periarticular Locking Plate SystemZimmer, Inc.20131—
+4K130008Distal Ulna Locking Plate (Dul), Ulna Osteotomy Locking Plate (Uol), 3.0 Cancellous…I.T.S. GmbH201311
+4K130061Piccolo Composite Plate SystemCarboFix Orthopedics, Ltd.201310—
+4K122310Geminus Fossa Specific Plate SystemSkeletal Dynamics, LLC20130—
+4K120409Piccolo Composite Plate SystemCarboFix Orthopedics, Ltd.201211—
+4K120689Synthes 3.5 MM VA-LCP Proximal Tibia Plate SystemSynthes (USA) Products, LLC201228—
+4K110895Ortho Solutions Trauma Implants for OsteosynthesisOrtho Solutions Limited20118—
+4K110959Orthopediatrics Blade Plate SystemOrthoPediatrics Corp.201123
+4K111086Orthopediatrics Fracture and Osteotomy Bone Plate SystemOrthoPediatrics Corp.201171
+4K101930Memometal Navis Bone Plating SystemMemometal Technologies20110—
+4K102095Suspension Clavicle Fracture Fixation SystemSuspension Orthopaedic Solutions, LLC20102—
+4K100944Clavicle Locking Plate SystemNewclip Technics20109—
+4K093868I.T.S. LRS Locking Reconstruction SystemI.T.S. Implantat-Technologie-Systeme GmbH201011
+4K100240Orthopediatrics Pediloc Tibia Plate SystemOrthoPediatrics Corp.201013—
+4K093983Smple Plate and ScrewsBiomet Trauma (Aka Ebi, Lp)20100—