510(k) Report

Devices descending from K982222

716 later devices reach Synthes (Usa) Distal Femur Plate (DFP) System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K031875Inter-OS Limb LengthenerInter-Os Technologies20034—
+1K022139Hip Tool ImplantOrthopedic Sciences, Inc.20027—
+1K000066Synthes (Usa) Locking Condylar Plate (LCP) SystemSynthes (Usa)2000713—
+2K192745DePuy Synthes Trauma ScrewsSynthes (Usa) Products, LLC / Depuy Orthopaedics, Inc.20195—
+2K192181PRECICE Plating SystemNuvasive Specialized Orthopedics, Inc.201921
+2K190750DePuy Synthes Plates and Screws PortfolioDePuy Synthes20190—
+2K140119Emerge Medical Periarticular and Locking Large Fragment SystemEmerge Medical20141—
+2K111891Synthes Brainlab Trauma Compatible InstrumentsSynthes (USA) Products, LLC20110—
+2K1103544.5MM VA-LCP Curved Condylar Plate SystemSynthes USA2011622
+2K063709TS-Bone Hip ToolOrthopedic Sciences, Inc.20071—
+2K052538S-Bone Hip ToolOrthopedic Sciences, Inc.20050—
+2K051162Generos SB Small Bone Distraction ImplantOrthonetx, Inc.20050—
+2K051032Titanium-Hip ToolOrthopedic Sciences, Inc.20050—
+2K051181Custom-Hip ToolOrthopedic Sciences, Inc.20050—
+2K042598Periarticular Locking Plates and Screws, 2357 and 2359 SeriesZimmer, Inc.2004311
+2K042237Ebi Periarticular Plating SystemEbi, L.P.2004310
+2K040850Tsy Shoulder Plate ImplantOrthopedic Sciences, Inc.20041—
+2K033669Smith & Nephew Locking Bone Plate System (Locking Bone Plates and Screws)Smith & Nephew, Inc.20036901
+3K213126Smith & Nephew, Inc. Plates and Screws Systems: EVOS, Peri-Loc, D-Rad, TC-100, VLP…Smith & Nephew, Inc.202221
+3K220319Asnis III Cannulated Screw System, Asnis PRO Cannulated Screw SystemStryker GmbH20221—
+3K211783TriMed Threaded Intramedullary Nail SystemTriMed, Inc.20212—
+3K210837Smith & Nephew Plates and ScrewsSmith & Nephew, Inc.202171
+3K203405EVOS Large Fragment Plating SystemSmith & Nephew, Inc.20213—
+3K202348External Remote Controller ERC 4PNuvasive Specialized Orthopedics, Inc.20200—
+3K201918EVOS Large Fragment Plating SystemSmith & Nephew, Inc.202044
+3K193617Precice® ScrewsNuvasive Specialized Orthopedics, Inc.20200—
+3K173293EVOS Small Fragment Upper Extremity PlatesSmith & Nephew, Inc.201812—
+3K170704The Locking Pediatric Osteotomy Plate (LolliPOP) SystemPega Medical, Inc.20170—
+3K162124Synthes 4.5mm VA-LCP Curved Condylar Plate System Line Extension, Variable Angle…DePuy Synthes20176—
+3K162078EVOS Small Fragment Plating SystemSmith & Nephew, Inc.2016261
+3K161058Cannulated ScrewMiami Device Solutions, LLC20161—
+3K160633G3(TM) Active Plate (R) Small Fragment SystemGenesis Fracture Care, Inc.20160—
+3K152242G3¿ Active Plate® Large Fragment SystemGenesis Fracture Care, Inc.20151—
+3K141527Depuy Synthes Variable Angle Locking Hand SystemSynthes USA20157—
+3K141825IDEAL Locking Plate SystemJiangsu Ideal Medical Science & Technology Co., LT20150—
+3K142938G3 Active Plate Large Fragment SystemGenesis Fracture Care, Inc.20143—
+3K141347Emerge Medical IM Nail SystemEmerge Medical20140—
+3K141734Zimmer Periarticular Locking SystemZimmer, Inc.201403
+3K140357Oic Variable Angle Small Fragment Locking Plate SystemOrthopaedic Implant Company20142—
+3K130810Zimmer Motionloc Screw for Periarticular Locking Plate SystemZimmer, Inc.20131—
+3K121601Synthes 2.7/3.5MM Variable Angle LCP Ankle Trauma System-Anterolateral Distal Tibia PlateSynthes USA20126—
+3K120854Synthes VA LCP Ankle Trauma SystemSynthes USA201244—
+3K111447Zimmer Periarticular ScrewsZimmer, Inc.201114
+3K110670VLP Foot Talus Plates, VLP Percutaneous Calcaneus Plates and Misc VLP Bone Screws…Smith & Nephew, Inc.201169—
+3K111039Zimmer Periarticular Locking Plate SystemZimmer, Inc.201134
+3K100325Peri-Loc Locking Hole Inserts and Cable AccessoriesSmith & Nephew, Inc.201038—
+3K092078Optilock Periarticular PlatingBiomet Trauma20092—
+3K092015Peri-Loc Periarticular Locked Plating SystemSmith & Nephew, Inc.2009411
+3K090675Smith & Nephew, Inc. VLP Foot Plating, Screw System and AccessoriesSmith & Nephew, Inc.2009487—
+3K083286Orthopediatrics Pediloc Locking Plate SystemOrthoPediatrics Corp.2009605
+3K083032Peri-Loc Bone Plating and Screw SystemSmith & Nephew, Inc.2009772
+3K082807Synthes (Usa) 3.5 and 4.5 MM Locking Compression Plate System with Expanded IndicationsSynthes (Usa)2008186—
+3K082516Peri-Loc Periarticular Locked Plating System Hexalobular Bone ScrewsSmith & Nephew, Inc.200887—
+3K081513Merete 3.0 and 3.5 MM Locking ScrewsMerete Medical GmbH2008256—
+3K081106Peri-Loc Periarticular Locked Plating System Volar Distal Radius Locking Plate for the…Smith & Nephew, Inc.200834—
+3K080434Intertan CHS Locking Plate System Prox Fem Plates/ScrewSmith & Nephew, Inc.200835—
+3K072818Peri-Loc Periartricular LCK Pit Sys-Prox Fem Plates/Screws.Calbe AccessSmith & Nephew, Inc.200793—
+3K072175Titanium Hip Tool Locking PlateOrthopedic Sciences, Inc.20070—
+3K071563Peri-Loc Periarticular Locked Plating SystemSmith & Nephew, Inc.2007495—
+3K063487Merete BLP Small Fragment Locking Bone PlateMerete Medical GmbH2007257—
+3K063033Modification to Titanium Shoulder Plate ImplantOrthopedic Sciences, Inc.20060—
+3K062216Peri-Loc Periarticular Locked Plating SystemSmith & Nephew, Inc.20065011
+3K061352Peri-Loc Periarticular Locked Plating System for the Upper ExtremitySmith & Nephew, Inc.2006108—
+3K051735Peri-Loc Locking Bone Plates and Locking Bone Screws for the Upper ExtremitySmith & Nephew, Inc.2005584—
+3K050457Merete Metafix Small Fragment Bone Plate SystemMerete Medical GmbH2005258—
+3K050121Zimmer Periarticular Locking Plate System, Model 2357 & 2359Zimmer, Inc.200527—
+4K261351SALGINA 2.5mm Distal Radius SystemBonebridge AG20260—
+4K253906Xpert HandNewclip Technics20260—
+4K254093DePuy Synthes VOLT™ Medial Distal Femur 3.5 Plating SystemSynthes GmbH20260—
+4K253713Arthrex Variable Angle (VA) Proximal Tibia Plating SystemArthrex, Inc.20260—
+4K252191BRUSIO Trauma Toolbox System; TAMINA 3.5mm Proximal Humerus SystemBonebridge AG20250—
+4K252019CurvaFix Low Profile SystemCurvafix, Inc.20250—
+4K250933LORRAINE 2.5/3.5mm Distal Humerus SystemBonebridge AG20251—
+4K243963Pediatric Plating Platform HipOrthoPediatrics Corp.20250—
+4K242973CanMINI Hand and Foot SystemCanwell Medical Co., Ltd.20250—
+4K241666EVOS Pelvic and Acetabular SystemSmith & Nephew20250—
+4K243308Bonebridge Osteosynthesis Plating System (SALGINA 2.5mm Distal Radius System, CASCELLA…Bonebridge AG20241—
+4K242079Arthrex Elbow Fracture Plating SystemArthrex, Inc.20240—
+4K242814Tandry Q-Locking Plate SystemMicroware Precision Co., Ltd.20240—
+4K242399Bonebridge Osteosynthesis Plating SystemBonebridge AG20241—
+4K242554Arthrex VAL and VAL KreuLock™ Compression Screw SystemArthrex, Inc.20241—
+4K240318SITTER 3.5mm Versatile SystemBonebridge AG20244—
+4K233665DePuy Synthes VOLT Mini Fragment Plating System, DePuy Synthes VOLT Small Fragment…DePuy Synthes20244—
+4K233912ARIX Cannulated Screw SystemJeil Medical Corporation20240—
+4K234040TriMed Threaded Intramedullary Nail SystemTriMed, Inc.202402
+4K233396Cannulated Screw SystemSmith & Nephew, Inc.20230—
+4K233017TM Plating SystemTyber Medical, LLC20231—
+4K232394Internal Locking Plate and Screw Fixation SystemChangzhou Geasure Medical Apparatus and Instruments Co., Ltd.20230—
+4K231333STRETTO™ Cable SystemGlobus Medical, Inc.20230—
+4K231292TAMINA 3.5mm Proximal Humerus System; POYA 3.5MM Lateral Proximal Tibia System; LORRAINE…Bonebridge AG20237—
+4K230971APTUS® 3.5 TriLock Straight PlatesMedartis AG20232—
+4K230749TriMed Threaded Intramedullary Nail SystemTriMed, Inc.20231—
+4K221150Advanced Bone PlateDouble Medical Technology, Inc.20231—
+4K223118OIC Variable Angle Small Fragment Locking Plate SystemOrthopaedic Implant Company20231—
+4K213108Humerus & Ulna SystemAuxein Medical Private Limited20221—
+4K222282HEMC BRAND Locking Bone Plates and Screws Osteosynthesis Plating SystemHospital Equipment Manufacturing Company20221—
+4K212601DRPx Locking Distal Radius Plate SystemOrthopaedic Implant Company20220—
+4K200575Truemed Hand, Foot and Ankle Plates SystemTruemed Group, LLC20210—
+4K210157SOLE Medial Column Fusion PlateOrthofix Srl20210—
+4K200062Foot and Ankle SystemLeith Medical, LLC20210—