510(k) Report

Devices descending from K991407

709 later devices reach Synthes Locking Calcaneal Plates through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K254054VOLT™ Ankle Trauma 2.7/3.5 Plating System; VOLT™ Calcaneus 2.7 Plating SystemSynthes GmbH20260—
+1K182818LOQTEQ VA Calcaneus Plate 3.5Aap Implantate AG20190—
+1K190750DePuy Synthes Plates and Screws PortfolioDePuy Synthes20190—
+1K160553DePuy Synthes 4.0 mm and 5.0 mm Locking Screws – MR Conditional, DePuy Synthes Wrist…Synthes (Usa) Products, LLC / Depuy Orthopaedics, Inc.20170—
+1K161894SurgTech Trauma SystemSurgtech, Inc.20173—
+1K150471CalcaNail Orthopedic Arthrodesis NailFournitures Hospitalieres Industrie20150—
+1K150463CalcaNail Orthopedic NailFournitures Hospitalieres Industrie20150—
+1K133930Flower Rear Foot Plating Set, Flower Calcaneus Planting Set, Flower Rearfoot Plating SetFlower Orthopedics Corporation201406
+1K131186Synthes 2.7MM and 3.5MM Variable Angle LCP Midfoot/Hindfoot SystemSynthes (USA) Products, LLC20138—
+1K110908Aptus Foot 3.5 SystemMedartis AG201125—
+1K090582Calcaneal Fracture Plate SystemTornier, Inc.200912—
+1K071105Osteomed Calcaneal Plate and Screw Fixation SystemOsteomed LP20079—
+1K051642FR.O.H. Calcaneus Repair SystemI.T.S. Implantat-Technologie-Systeme GmbH2005281
+1K041786Calcamea PlateNew Deal, S.A.200413—
+1K033669Smith & Nephew Locking Bone Plate System (Locking Bone Plates and Screws)Smith & Nephew, Inc.20036901
+1K022515Biomet Calcaneal PlateBiomet Orthopedics, Inc.20020—
+2K260958I.T.S. Clavicle Plates with Angular Stability; I.T.S. Volar Radius Plate with Angular…I.T.S. GmbH20260—
+2K243469SignexOsteonic Co., Ltd.20250—
+2K242939ARTFX Trauma Bone Plate and Screw SystemArtfx Medical20242—
+2K232105APTUS Foot System 2.8-3.5Medartis AG20240—
+2K233665DePuy Synthes VOLT Mini Fragment Plating System, DePuy Synthes VOLT Small Fragment…DePuy Synthes20244—
+2K223150APS Metal Plate & Screw SystemA Plus Biotechnology Co., Ltd.20230—
+2K230971APTUS® 3.5 TriLock Straight PlatesMedartis AG20232—
+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
+2K203405EVOS Large Fragment Plating SystemSmith & Nephew, Inc.20213—
+2K201918EVOS Large Fragment Plating SystemSmith & Nephew, Inc.202044
+2K190992OrthoPediatrics PediFoot Deformity Corrections SystemOrthoPediatrics Corp.20190—
+2K173293EVOS Small Fragment Upper Extremity PlatesSmith & Nephew, Inc.201812—
+2K170704The Locking Pediatric Osteotomy Plate (LolliPOP) SystemPega Medical, Inc.20170—
+2K162674BioPro Foot Plating SystemsBiopro, Inc.201719—
+2K162078EVOS Small Fragment Plating SystemSmith & Nephew, Inc.2016261
+2K160633G3(TM) Active Plate (R) Small Fragment SystemGenesis Fracture Care, Inc.20160—
+2K143365Eminent Foot Plate SystemEminent Spine20151—
+2K142938G3 Active Plate Large Fragment SystemGenesis Fracture Care, Inc.20143—
+2K140357Oic Variable Angle Small Fragment Locking Plate SystemOrthopaedic Implant Company20142—
+2K132898A.L.P.S. Calcaneal Plating SystemBiomet Manufacturing Corp201311—
+2K131445Osteomed Extremilock Foot Plating SystemOsteomed LP20138—
+2K110670VLP Foot Talus Plates, VLP Percutaneous Calcaneus Plates and Misc VLP Bone Screws…Smith & Nephew, Inc.201169—
+2K100325Peri-Loc Locking Hole Inserts and Cable AccessoriesSmith & Nephew, Inc.201038—
+2K092015Peri-Loc Periarticular Locked Plating SystemSmith & Nephew, Inc.2009411
+2K090675Smith & Nephew, Inc. VLP Foot Plating, Screw System and AccessoriesSmith & Nephew, Inc.2009487—
+2K083286Orthopediatrics Pediloc Locking Plate SystemOrthoPediatrics Corp.2009605
+2K083032Peri-Loc Bone Plating and Screw SystemSmith & Nephew, Inc.2009772
+2K082807Synthes (Usa) 3.5 and 4.5 MM Locking Compression Plate System with Expanded IndicationsSynthes (Usa)2008186—
+2K082516Peri-Loc Periarticular Locked Plating System Hexalobular Bone ScrewsSmith & Nephew, Inc.200887—
+2K081513Merete 3.0 and 3.5 MM Locking ScrewsMerete Medical GmbH2008256—
+2K081106Peri-Loc Periarticular Locked Plating System Volar Distal Radius Locking Plate for the…Smith & Nephew, Inc.200834—
+2K080434Intertan CHS Locking Plate System Prox Fem Plates/ScrewSmith & Nephew, Inc.200835—
+2K072818Peri-Loc Periartricular LCK Pit Sys-Prox Fem Plates/Screws.Calbe AccessSmith & Nephew, Inc.200793—
+2K071563Peri-Loc Periarticular Locked Plating SystemSmith & Nephew, Inc.2007495—
+2K063487Merete BLP Small Fragment Locking Bone PlateMerete Medical GmbH2007257—
+2K063166I.T.S. Pelvic Reconstruction SystemI.T.S. Implantat-Technologie-Systeme GmbH200692
+2K062216Peri-Loc Periarticular Locked Plating SystemSmith & Nephew, Inc.20065011
+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
+2K051735Peri-Loc Locking Bone Plates and Locking Bone Screws for the Upper ExtremitySmith & Nephew, Inc.2005584—
+2K050457Merete Metafix Small Fragment Bone Plate SystemMerete Medical GmbH2005258—
+3K261830FRAXION 3.5 Plate System (Various - See Catalog);FRAXION 4.5 Plate System (Various - See…Ortler Global Tibbi Gerecler Anonim Sirketi20260—
+3K260277Mikron Trauma Bone Plate& Screw SystemMikron Makina San. ve Tic. Ltd. Sti.20260—
+3K261351SALGINA 2.5mm Distal Radius SystemBonebridge AG20260—
+3K260054I.T.S. PRS Phoenix III.T.S. GmbH20260—
+3K254093DePuy Synthes VOLT™ Medial Distal Femur 3.5 Plating SystemSynthes GmbH20260—
+3K260069DePuy Synthes VOLT™ Proximal Tibia 3.5 Plating SystemSynthes GmbH20260—
+3K253713Arthrex Variable Angle (VA) Proximal Tibia Plating SystemArthrex, Inc.20260—
+3K252191BRUSIO Trauma Toolbox System; TAMINA 3.5mm Proximal Humerus SystemBonebridge AG20250—
+3K251709MedCAD® AccuStride™ SystemMedcad20250—
+3K251892MAXXOS P.A.C.E. Foot & Ankle Plating SystemMaxxos Medical GmbH20250—
+3K252019CurvaFix Low Profile SystemCurvafix, Inc.20250—
+3K251361Tyber Medical Distal Radius Plating SystemTyber Medical, LLC20250—
+3K250933LORRAINE 2.5/3.5mm Distal Humerus SystemBonebridge AG20251—
+3K243963Pediatric Plating Platform HipOrthoPediatrics Corp.20250—
+3K242973CanMINI Hand and Foot SystemCanwell Medical Co., Ltd.20250—
+3K241666EVOS Pelvic and Acetabular SystemSmith & Nephew20250—
+3K243308Bonebridge Osteosynthesis Plating System (SALGINA 2.5mm Distal Radius System, CASCELLA…Bonebridge AG20241—
+3K242079Arthrex Elbow Fracture Plating SystemArthrex, Inc.20240—
+3K242399Bonebridge Osteosynthesis Plating SystemBonebridge AG20241—
+3K242554Arthrex VAL and VAL KreuLock™ Compression Screw SystemArthrex, Inc.20241—
+3K240318SITTER 3.5mm Versatile SystemBonebridge AG20244—
+3K233396Cannulated Screw SystemSmith & Nephew, Inc.20230—
+3K233017TM Plating SystemTyber Medical, LLC20231—
+3K232394Internal Locking Plate and Screw Fixation SystemChangzhou Geasure Medical Apparatus and Instruments Co., Ltd.20230—
+3K232251APTUS Cannulated Compression Screws Line Extension, APTUS K-Wire System Line ExtensionMedartis AG20231—
+3K231292TAMINA 3.5mm Proximal Humerus System; POYA 3.5MM Lateral Proximal Tibia System; LORRAINE…Bonebridge AG20237—
+3K221150Advanced Bone PlateDouble Medical Technology, Inc.20231—
+3K223118OIC Variable Angle Small Fragment Locking Plate SystemOrthopaedic Implant Company20231—
+3K213108Humerus & Ulna SystemAuxein Medical Private Limited20221—
+3K222282HEMC BRAND Locking Bone Plates and Screws Osteosynthesis Plating SystemHospital Equipment Manufacturing Company20221—
+3K210935I.T.S. Pelvic Reconstruction System (PRS RX & PRS Phoenix)I.T.S. GmbH202231
+3K221346Stryker VariAx 2 MIS CalcaneusStryker GmbH20220—
+3K221395Footmotion Plating SystemNewclip Technics20220—
+3K212601DRPx Locking Distal Radius Plate SystemOrthopaedic Implant Company20220—
+3K210157SOLE Medial Column Fusion PlateOrthofix Srl20210—
+3K201527EVOS Straight Proximal Humerus 7-15 hole Plates (137-225mm)Smith & Nephew, Inc.20208—
+3K200701Skeletal Dynamics Midshaft Humerus Plating SystemSkeletal Dynamics, Inc.20200—
+3K193222Tyber Medical Anatomical Plating SystemTyber Medical, LLC202011—
+3K191793Nebula Brand Locking Bone Plates and Screws Osteosynthesis Plating System, Nebula Brand…Nebula Surgical Private Limited20193—
+3K190391TDM Plate and Screw SystemsTdm Co., Ltd.20191—
+3K191009Arsenal Plating SystemTrilliant Surgical20192—
+3K190253EVOS Small Fragment Upper Extremity Plates Line AdditionsSmith & Nephew, Inc.20199—