510(k) Report

Devices descending from K001941

800 later devices reach Synthes Modular Foot System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+5K242348Locking Screw,CoCrMoDouble Medical Technology, Inc.20240—
+5K241815Protean Fragment Plating SystemSkeletal Dynamics, Inc.20240—
+5K240487EVOS Patella PlatesSmith & Nephew20240—
+5K233816REDEMPTION Charcot Plating SystemVilex, LLC20240—
+5K241932OSSIOfiber® Compression StapleOSSIO, Ltd.20240—
+5K241539Activmotion SNewclip Technics20240—
+5K233919VariAx 2 Distal Radius SystemStryker GmbH20242—
+5K234062APTUS Hand Scaphoid PlatesMedartis AG20243—
+5K231684Quick - Radius Disposable SetGM Dos Reis Industria e Comercio Ltda.20240—
+5K232652Anatomical Plating System (various)Tyber Medical, LLC2023320
+5K232515Valkyrie Thoracic Fixation SystemJm Longyear Manufacturing, LLC D/B/A Able Medical Devices20230—
+5K232693Tyber Medical Distal Radius Plating SystemTyber Medical, LLC20231—
+5K233302OSSIOfiber® Compression StapleOSSIO, Ltd.20231—
+5K231231MR Safety and Compatibility Testing and Labeling for Paragon 28 Orthopedic Fixation…Paragon 28, Inc.20231—
+5K231292TAMINA 3.5mm Proximal Humerus System; POYA 3.5MM Lateral Proximal Tibia System; LORRAINE…Bonebridge AG20237—
+5K230257Arthrex Intramedullary NailsArthrex, Inc.20231—
+5K222465Tyber Medical Anatomical Plating SystemTyber Medical, LLC20239—
+5K222799Haymaker® Screw SystemOrthocircle Spine D.B.A. OC Medical Devices20230—
+5K222820BRM TOOL Screws, BIOPLAN Subtalar ImplantBrm Extremities20220—
+5K213123EVOS Wrist Spanning PlateSmith & Nephew, Inc.20220—
+5K221360Medline UNITE® Medial Malleolus Peg Plate SystemMedline Industries, LP20220—
+5K213864Bonebridge Osteosynthesis Plating SystemBonebridge AG20228—
+5K220937Arthrex Mini Fragment SystemArthrex, Inc.20222—
+5K220181StealthFix Intraosseous Fixation SystemNextremity Solutions, Inc.20221—
+5K213572JuniOrtho Plating System™Orthofix Srl20220—
+5K212487CoLink Vallux Plating SystemIn2bones USA, LLC20214—
+5K213036Treace Medical Concepts (TMC) Screw Fixation SystemTreace Medical Concepts, Inc.20217—
+5K203817Tyber Medical Anatomical Plating SystemTyber Medical, LLC202110—
+5K211051DePuy Synthes 2.7mm Straight and 2.7mm Adaption Plates (Modular Mini Fragment LCP System)DePuy Synthes20211—
+5K210157SOLE Medial Column Fusion PlateOrthofix Srl20210—
+5K210658Volition Plating SystemOrtho Solutions UK, Ltd.20210—
+5K203479ExtremiLOCK Lateral Ankle Fusion PlatesOsteomed20210—
+5K202657Javelin Tailor's Bunion Fixation SystemNvision Biomedical Technologies, Inc.20201—
+5K202817GEO Bone Screw SystemGramercy Extremity Orthopedics, LLC20201—
+5K201917Piccolo Composite Proximal Tibia Plate SystemCarboFix Orthopedics, Ltd.20200—
+5K201527EVOS Straight Proximal Humerus 7-15 hole Plates (137-225mm)Smith & Nephew, Inc.20208—
+5K201430InFrame™ Cannulated Fixation SystemExsomed Corp.20201—
+5K200398AxSOS 3 AF System and AxSOS 3 Ti SystemStryker GmbH20209—
+5K200246JPS JuniOrtho Plating SystemOrthofix Srl20201—
+5K193614FINE Osteotomy around the kneeBodycad Laboratories, Inc.20204—
+5K192163TTC Phantom® Intramedullary Nail SystemParagon 28, Inc.20206—
+5K192592Axis Plating SystemExtremity Medical, LLC20190—
+5K192181PRECICE Plating SystemNuvasive Specialized Orthopedics, Inc.201921
+5K191782TTC Phantom Intramedullary Nail SystemParagon 28, Inc.20196—
+5K191412VariAx 2 System, VariAx 2 Mini Fragment SystemStryker GmbH201910—
+5K190722TriMAX Implant SystemCrossroads Extemity Systems, LLC20190—
+5K183363Treace Medical Concepts (TMC) Snap-Off Screw SystemTreace Medical Concepts, Inc.20191—
+5K181296Syntec Femoral Nail SystemSyntec Scientific Corporation20192—
+5K190253EVOS Small Fragment Upper Extremity Plates Line AdditionsSmith & Nephew, Inc.20199—
+5K183317AdvantageRib SystemSig Medical Corporation20194—
+5K182810Distal Radius Plating SystemMiami Device Solutions, LLC20180—
+5K173556Injection ScrewBiedermann Medtech, Inc.20180—
+5K181113CoLink™ Afx Plating SystemIn2bones USA, LLC201814—
+5K170704The Locking Pediatric Osteotomy Plate (LolliPOP) SystemPega Medical, Inc.20170—
+5K172262EVOS Small Fragment Plating SystemSmith & Nephew, Inc.20179—
+5K162153Integra® CAPTURE™ Screw System & Integra® Ti6® Internal Fixation SystemAscension Orthopedics20171—
+5K171448Hammertoe Correction SystemLife Spine, Inc.20170—
+5K1626852-Piece Hammertoe Correction SystemLife Spine, Inc.20170—
+5K170687Flower Bone Screw SetFlower Orthopedics Corporation20170—
+5K162124Synthes 4.5mm VA-LCP Curved Condylar Plate System Line Extension, Variable Angle…DePuy Synthes20176—
+5K162898Olecranon Plating SystemMiami Device Solutions, LLC20171—
+5K162841VariAx Distal Radius Plating System, VariAx 2 SystemStryker GmbH20174—
+5K163086VLP MINI-MOD 2.0mm Column PlatesSmith & Nephew, Inc.20160—
+5K162635Distal Radius Plating SystemMiami Device Solutions, LLC20162—
+5K162307OrthoPediatrics Locking Proximal Femur System Cortical ScrewsOrthoPediatrics Corp.20161—
+5K153379AxSOS 3TiStryker GmbH201625—
+5K161041OsteoMed ExtremiLOCK Wrist Plating SystemOsteomed20160—
+5K151848Cable-Ready® Cable Grip System: Cable-Ready Pin System, Cable-Ready Needle SystemZimmer, Inc.20161—
+5K152306MotoBand¿ CP Implant SystemCrossroads Extremity Systems, LLC20157—
+5K152242G3¿ Active Plate® Large Fragment SystemGenesis Fracture Care, Inc.20151—
+5K150649G3 Active Plate Large Fragment SystemGenesis Fracture Care, Inc.20152—
+5K141527Depuy Synthes Variable Angle Locking Hand SystemSynthes USA20157—
+5K143039CrossRoads Screw SystemOrthodiscovery Group, LLC (D.B.A. Crossroads Extrem201579—
+5K143050VLP Mini-Mod Small Bone Plating System 1.5mm Plates and ScrewsSmith & Nephew, Inc.20148—
+5K140769Variax 2 SystemStryker Trauma AG201419—
+5K133102Flower Ankle Plating SetFlower Orthopedics Corporation20130—
+5K132248Flower Bone Screw SetFlower Orthopedics Corporation20131—
+5K131657Flower Small and Medium Implant SetFlower Orthopedics Corporation2013111
+5K130479Ilizarov Drill Tip WiresSmith & Nephew, Inc.20136—
+5K124027Monster Screw SystemApogee Orthosolutions201341—
+5K113405Suspension Clavicle Fracture Repair SystemSuspension Orthopaedic Solutions, LLC20120—
+5K112923Suspension Clavicle Fracture Fixation SystemSuspension Orthopaedic Solutions, LLC20110—
+5K111994Smith & Nephew Cannulated Screws and WashersSmith & Nephew, Inc.2011161—
+5K093047Smith & Nephew Circular Fixation SystemSmith & Nephew, Inc.2010511
+5K100776Synthes 2.4 MM/2.7 MM Variable Angle LCP Forefoot/Midfoot SystemSynthes (Usa)2010228—
+6K262963TMC Implant Fixation SystemTreace Medical Concepts, Inc.20260—
+6K261271Cable-Ready® Cable Grip SystemPioneer Surgical Technology, Inc.20260—
+6K262032TriMed Non-Spanning Wrist Fusion Plates (NSFL-STD);TriMed Non-Spanning Wrist Fusion…TriMed, Inc.20260—
+6K260810Anteralign LS coverplateTyber Medical, LLC20260—
+6K260228POYA 3.5mm Medial Proximal Tibia SystemBonebridge AG20260—
+6K260291Vortex5 Tailor's Bunion Correction SystemNvision Biomedical Technologies, Inc.20260—
+6K253916APTUS Shoulder Proximal Humerus System, PentaLock 3.5Medartis AG20260—
+6K253906Xpert HandNewclip Technics20260—
+6K254054VOLT™ Ankle Trauma 2.7/3.5 Plating System; VOLT™ Calcaneus 2.7 Plating SystemSynthes GmbH20260—
+6K251850Phantom® Hindfoot TTC/TC Nail SystemParagon 28, Inc.20251—
+6K250933LORRAINE 2.5/3.5mm Distal Humerus SystemBonebridge AG20251—
+6K242486Tyber Medical Anatomical Plating SystemTyber Medical, LLC20251—
+6K243890Arthrex Intramedullary NailsArthrex, Inc.20250—
+6K242814Tandry Q-Locking Plate SystemMicroware Precision Co., Ltd.20240—
+6K242399Bonebridge Osteosynthesis Plating SystemBonebridge AG20241—