510(k) Report

Devices descending from K981372

710 later devices reach Synthes 3.0 MM PC-Fix System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K991407Synthes Locking Calcaneal PlatesSynthes (Usa)1999709—
+2K254054VOLT™ Ankle Trauma 2.7/3.5 Plating System; VOLT™ Calcaneus 2.7 Plating SystemSynthes GmbH20260—
+2K182818LOQTEQ VA Calcaneus Plate 3.5Aap Implantate AG20190—
+2K190750DePuy Synthes Plates and Screws PortfolioDePuy Synthes20190—
+2K160553DePuy Synthes 4.0 mm and 5.0 mm Locking Screws – MR Conditional, DePuy Synthes Wrist…Synthes (Usa) Products, LLC / Depuy Orthopaedics, Inc.20170—
+2K161894SurgTech Trauma SystemSurgtech, Inc.20173—
+2K150471CalcaNail Orthopedic Arthrodesis NailFournitures Hospitalieres Industrie20150—
+2K150463CalcaNail Orthopedic NailFournitures Hospitalieres Industrie20150—
+2K133930Flower Rear Foot Plating Set, Flower Calcaneus Planting Set, Flower Rearfoot Plating SetFlower Orthopedics Corporation201406
+2K131186Synthes 2.7MM and 3.5MM Variable Angle LCP Midfoot/Hindfoot SystemSynthes (USA) Products, LLC20138—
+2K110908Aptus Foot 3.5 SystemMedartis AG201125—
+2K090582Calcaneal Fracture Plate SystemTornier, Inc.200912—
+2K071105Osteomed Calcaneal Plate and Screw Fixation SystemOsteomed LP20079—
+2K051642FR.O.H. Calcaneus Repair SystemI.T.S. Implantat-Technologie-Systeme GmbH2005281
+2K041786Calcamea PlateNew Deal, S.A.200413—
+2K033669Smith & Nephew Locking Bone Plate System (Locking Bone Plates and Screws)Smith & Nephew, Inc.20036901
+2K022515Biomet Calcaneal PlateBiomet Orthopedics, Inc.20020—
+3K260958I.T.S. Clavicle Plates with Angular Stability; I.T.S. Volar Radius Plate with Angular…I.T.S. GmbH20260—
+3K243469SignexOsteonic Co., Ltd.20250—
+3K242939ARTFX Trauma Bone Plate and Screw SystemArtfx Medical20242—
+3K232105APTUS Foot System 2.8-3.5Medartis AG20240—
+3K233665DePuy Synthes VOLT Mini Fragment Plating System, DePuy Synthes VOLT Small Fragment…DePuy Synthes20244—
+3K223150APS Metal Plate & Screw SystemA Plus Biotechnology Co., Ltd.20230—
+3K230971APTUS® 3.5 TriLock Straight PlatesMedartis AG20232—
+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
+3K203405EVOS Large Fragment Plating SystemSmith & Nephew, Inc.20213—
+3K201918EVOS Large Fragment Plating SystemSmith & Nephew, Inc.202044
+3K190992OrthoPediatrics PediFoot Deformity Corrections SystemOrthoPediatrics Corp.20190—
+3K173293EVOS Small Fragment Upper Extremity PlatesSmith & Nephew, Inc.201812—
+3K170704The Locking Pediatric Osteotomy Plate (LolliPOP) SystemPega Medical, Inc.20170—
+3K162674BioPro Foot Plating SystemsBiopro, Inc.201719—
+3K162078EVOS Small Fragment Plating SystemSmith & Nephew, Inc.2016261
+3K160633G3(TM) Active Plate (R) Small Fragment SystemGenesis Fracture Care, Inc.20160—
+3K143365Eminent Foot Plate SystemEminent Spine20151—
+3K142938G3 Active Plate Large Fragment SystemGenesis Fracture Care, Inc.20143—
+3K140357Oic Variable Angle Small Fragment Locking Plate SystemOrthopaedic Implant Company20142—
+3K132898A.L.P.S. Calcaneal Plating SystemBiomet Manufacturing Corp201311—
+3K131445Osteomed Extremilock Foot Plating SystemOsteomed LP20138—
+3K110670VLP Foot Talus Plates, VLP Percutaneous Calcaneus Plates and Misc VLP Bone Screws…Smith & Nephew, Inc.201169—
+3K100325Peri-Loc Locking Hole Inserts and Cable AccessoriesSmith & Nephew, Inc.201038—
+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—
+3K071563Peri-Loc Periarticular Locked Plating SystemSmith & Nephew, Inc.2007495—
+3K063487Merete BLP Small Fragment Locking Bone PlateMerete Medical GmbH2007257—
+3K063166I.T.S. Pelvic Reconstruction SystemI.T.S. Implantat-Technologie-Systeme GmbH200692
+3K062216Peri-Loc Periarticular Locked Plating SystemSmith & Nephew, Inc.20065011
+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
+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—
+4K261830FRAXION 3.5 Plate System (Various - See Catalog);FRAXION 4.5 Plate System (Various - See…Ortler Global Tibbi Gerecler Anonim Sirketi20260—
+4K260277Mikron Trauma Bone Plate& Screw SystemMikron Makina San. ve Tic. Ltd. Sti.20260—
+4K261351SALGINA 2.5mm Distal Radius SystemBonebridge AG20260—
+4K260054I.T.S. PRS Phoenix III.T.S. GmbH20260—
+4K254093DePuy Synthes VOLT™ Medial Distal Femur 3.5 Plating SystemSynthes GmbH20260—
+4K260069DePuy Synthes VOLT™ Proximal Tibia 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—
+4K251709MedCAD® AccuStride™ SystemMedcad20250—
+4K251892MAXXOS P.A.C.E. Foot & Ankle Plating SystemMaxxos Medical GmbH20250—
+4K252019CurvaFix Low Profile SystemCurvafix, Inc.20250—
+4K251361Tyber Medical Distal Radius Plating SystemTyber Medical, LLC20250—
+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—
+4K242399Bonebridge Osteosynthesis Plating SystemBonebridge AG20241—
+4K242554Arthrex VAL and VAL KreuLock™ Compression Screw SystemArthrex, Inc.20241—
+4K240318SITTER 3.5mm Versatile SystemBonebridge AG20244—
+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—
+4K232251APTUS Cannulated Compression Screws Line Extension, APTUS K-Wire System Line ExtensionMedartis AG20231—
+4K231292TAMINA 3.5mm Proximal Humerus System; POYA 3.5MM Lateral Proximal Tibia System; LORRAINE…Bonebridge AG20237—
+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—
+4K210935I.T.S. Pelvic Reconstruction System (PRS RX & PRS Phoenix)I.T.S. GmbH202231
+4K221346Stryker VariAx 2 MIS CalcaneusStryker GmbH20220—
+4K221395Footmotion Plating SystemNewclip Technics20220—
+4K212601DRPx Locking Distal Radius Plate SystemOrthopaedic Implant Company20220—
+4K210157SOLE Medial Column Fusion PlateOrthofix Srl20210—
+4K201527EVOS Straight Proximal Humerus 7-15 hole Plates (137-225mm)Smith & Nephew, Inc.20208—
+4K200701Skeletal Dynamics Midshaft Humerus Plating SystemSkeletal Dynamics, Inc.20200—
+4K193222Tyber Medical Anatomical Plating SystemTyber Medical, LLC202011—
+4K191793Nebula Brand Locking Bone Plates and Screws Osteosynthesis Plating System, Nebula Brand…Nebula Surgical Private Limited20193—
+4K190391TDM Plate and Screw SystemsTdm Co., Ltd.20191—
+4K191009Arsenal Plating SystemTrilliant Surgical20192—