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
+1K191972ARIX Wrist SystemJeil Medical Corporation20190—
+1K133939Modified Distal Radius Plating SystemBiomet2014112
+1K111663Trauma Internal Fixation SystemsDePuy Orthopaedics, Inc.2012117
+1K090374Sterile DVR Anatomic Plates Various Configurations) Model (S) 131212001,2, 5-10 2.5MM…DePuy Orthopaedics, Inc.200918—
+1K060864Multidirectional Threaded PegHand Innovations, LLC200618—
+1K051735Peri-Loc Locking Bone Plates and Locking Bone Screws for the Upper ExtremitySmith & Nephew, Inc.2005584—
+2K243761A.L.P.S. Small Fragment Plating SystemBiomet Orthopedics20250—
+2K213126Smith & Nephew, Inc. Plates and Screws Systems: EVOS, Peri-Loc, D-Rad, TC-100, VLP…Smith & Nephew, Inc.202221
+2K210837Smith & Nephew Plates and ScrewsSmith & Nephew, Inc.202171
+2K161665VLP Wrist Fracture SystemSmith & Nephew, Inc.201610—
+2K141493Proximal Humerus Plating SystemMiami Device Solutions201571
+2K140357Oic Variable Angle Small Fragment Locking Plate SystemOrthopaedic Implant Company20142—
+2K132296D-Rad Smart PackSmith & Nephew, Inc.2014114
+2K131636Polarus ConnectAcumed, LLC20130—
+2K123055Smith & Nephew, Inc Screw and Plate System InstrumentationSmith & Nephew, Inc.201333—
+2K122737Geminus Fossa Specific Plate SystemSkeletal Dynamics, LLC20123—
+2K120015Osteomed Wrist Plating SystemOsteomed LP20122—
+2K102597Piccolo Composite Plate SystemN.M.B. Medical Applications, Ltd.201115—
+2K100325Peri-Loc Locking Hole Inserts and Cable AccessoriesSmith & Nephew, Inc.201038—
+2K092015Peri-Loc Periarticular Locked Plating SystemSmith & Nephew, Inc.2009411
+2K083286Orthopediatrics Pediloc Locking Plate SystemOrthoPediatrics Corp.2009605
+2K083032Peri-Loc Bone Plating and Screw SystemSmith & Nephew, Inc.2009772
+2K082516Peri-Loc Periarticular Locked Plating System Hexalobular Bone ScrewsSmith & Nephew, Inc.200887—
+2K081106Peri-Loc Periarticular Locked Plating System Volar Distal Radius Locking Plate for the…Smith & Nephew, Inc.200834—
+2K071563Peri-Loc Periarticular Locked Plating SystemSmith & Nephew, Inc.2007495—
+2K061352Peri-Loc Periarticular Locked Plating System for the Upper ExtremitySmith & Nephew, Inc.2006108—
+2K060156Straight Plate with Angular Stability & Screw SystemI.T.S. Implantat-Technologie-Systeme GmbH2006272
+2K060041Trimed Bone PlatesTriMed, Inc.2006263
+3K260958I.T.S. Clavicle Plates with Angular Stability; I.T.S. Volar Radius Plate with Angular…I.T.S. GmbH20260—
+3K253713Arthrex Variable Angle (VA) Proximal Tibia Plating SystemArthrex, Inc.20260—
+3K252019CurvaFix Low Profile SystemCurvafix, Inc.20250—
+3K243963Pediatric Plating Platform HipOrthoPediatrics Corp.20250—
+3K242973CanMINI Hand and Foot SystemCanwell Medical Co., Ltd.20250—
+3K243987TriMed Elbow and Forearm SystemTriMed, Inc.20251—
+3K243999TriMed Ankle Fixation SystemTriMed, Inc.20252—
+3K242079Arthrex Elbow Fracture Plating SystemArthrex, Inc.20240—
+3K242554Arthrex VAL and VAL KreuLock™ Compression Screw SystemArthrex, Inc.20241—
+3K233396Cannulated Screw SystemSmith & Nephew, Inc.20230—
+3K233017TM Plating SystemTyber Medical, LLC20231—
+3K223118OIC Variable Angle Small Fragment Locking Plate SystemOrthopaedic Implant Company20231—
+3K212581VariAx 2 Distal Radius System, VariAx 2 Distal Ulna SystemStryker GmbH20224—
+3K213214Xpert WristNewclip Technics20210—
+3K203405EVOS Large Fragment Plating SystemSmith & Nephew, Inc.20213—
+3K201918EVOS Large Fragment Plating SystemSmith & Nephew, Inc.202044
+3K201917Piccolo Composite Proximal Tibia Plate SystemCarboFix Orthopedics, Ltd.20200—
+3K200538Skeletal Dynamics Forearm Plating SystemSkeletal Dynamics, Inc.20201—
+3K181843MLP Special Locking Bone Plate SystemMaxxion Medical, LLC / Baumer SA20190—
+3K182015Piccolo Composite® Plate SystemCarboFix Orthopedics, Ltd.20181—
+3K181533EVOS Wrist Fracture Plating SystemSmith & Nephew, Inc.20189—
+3K173293EVOS Small Fragment Upper Extremity PlatesSmith & Nephew, Inc.201812—
+3K172786MDS Plating SystemMiami Device Solutions, LLC20170—
+3K173121Ankle Fusion Plating SystemIn2bones Sas20172—
+3K173166ANTHEM Fracture SystemGlobus Medical, Inc.201711—
+3K170843Alians Fragment SpecificNewclip Technics20171—
+3K170457EVOS Small Fragment Lower Extremity PlatesSmith & Nephew, Inc.2017131
+3K170401Piccolo Composite® Plate SystemCarboFix Orthopedics, Ltd.20173—
+3K170887EVOS Small Fragment Plating SystemSmith & Nephew, Inc.201713—
+3K163361ANTHEM™ Fracture SystemGlobus Medical, Inc.201714—
+3K161894SurgTech Trauma SystemSurgtech, Inc.20173—
+3K162078EVOS Small Fragment Plating SystemSmith & Nephew, Inc.2016261
+3K161292Distal Radius Plating SystemMiami Device Solutions, LLC20164—
+3K161058Cannulated ScrewMiami Device Solutions, LLC20161—
+3K160995NEOVIEW Plating SystemIn2bones Sas201624
+3K160633G3(TM) Active Plate (R) Small Fragment SystemGenesis Fracture Care, Inc.20160—
+3K160002Piccolo Composite (R) Distal Volar Radius Plate SystemCarboFix Orthopedics, Ltd.20164—
+3K151735TriMed Humeral Supracondylar Fixation SystemTriMed, Inc.20160—
+3K152145OsteoMed ExtremiLOCK Wrist Plating SystemOsteomed20151—
+3K151886Acumed Ankle and Small Fragment Base Set UpdateAcumed, LLC201515—
+3K150693PHIN-FX Cannulated Lag Screw SystemAscent Medical, LLC20159—
+3K143496Piccolo Composite Plate SystemCarboFix Orthopedics, Ltd.20154—
+3K142938G3 Active Plate Large Fragment SystemGenesis Fracture Care, Inc.20143—
+3K140431Pediloc Fragment SystemOrthoPediatrics Corp.20141—
+3K141430Variax Distal Radius Plating SystemStryker Leibinger GmbH & Co KG201412—
+3K141121Axsos 3 TI Locking Plate SystemStryker Trauma AG201426—
+3K140814Evos Mini-Fragment Plating SystemSmith & Nephew, Inc.2014322
+3K132886Smith & Nephew Variable-Angle Locking Mini-Fragment Plating SystemSmith & Nephew, Inc.2014462
+3K130810Zimmer Motionloc Screw for Periarticular Locking Plate SystemZimmer, Inc.20131—
+3K130008Distal Ulna Locking Plate (Dul), Ulna Osteotomy Locking Plate (Uol), 3.0 Cancellous…I.T.S. GmbH201311
+3K130061Piccolo Composite Plate SystemCarboFix Orthopedics, Ltd.201310—
+3K122310Geminus Fossa Specific Plate SystemSkeletal Dynamics, LLC20130—
+3K120409Piccolo Composite Plate SystemCarboFix Orthopedics, Ltd.201211—
+3K120689Synthes 3.5 MM VA-LCP Proximal Tibia Plate SystemSynthes (USA) Products, LLC201228—
+3K110895Ortho Solutions Trauma Implants for OsteosynthesisOrtho Solutions Limited20118—
+3K110959Orthopediatrics Blade Plate SystemOrthoPediatrics Corp.201123
+3K111086Orthopediatrics Fracture and Osteotomy Bone Plate SystemOrthoPediatrics Corp.201171
+3K101930Memometal Navis Bone Plating SystemMemometal Technologies20110—
+3K102095Suspension Clavicle Fracture Fixation SystemSuspension Orthopaedic Solutions, LLC20102—
+3K100944Clavicle Locking Plate SystemNewclip Technics20109—
+3K093868I.T.S. LRS Locking Reconstruction SystemI.T.S. Implantat-Technologie-Systeme GmbH201011
+3K100240Orthopediatrics Pediloc Tibia Plate SystemOrthoPediatrics Corp.201013—
+3K093983Smple Plate and ScrewsBiomet Trauma (Aka Ebi, Lp)20100—
+3K091156Trimed Sterile ProductTriMed, Inc.20090—
+3K090675Smith & Nephew, Inc. VLP Foot Plating, Screw System and AccessoriesSmith & Nephew, Inc.2009487—
+3K063166I.T.S. Pelvic Reconstruction SystemI.T.S. Implantat-Technologie-Systeme GmbH200692
+4K262649Alians ForearmNewclip Technics20260—
+4K260809Arthrex Sterile VAL and VAL KreuLock™ Compression Screw SystemArthrex, Inc.20260—
+4K261207Exalta Proximal Tibia Plating SystemTyber Medical, LLC20260—
+4K260323OrthoPediatrics® Locking Cannulated Blade Plate SystemOrthoPediatrics Corp.20260—
+4K260054I.T.S. PRS Phoenix III.T.S. GmbH20260—
+4K252600Pediatric Plating Platform I Small-MiniOrthoPediatrics Corp.20250—