510(k) Report

Devices descending from K001941

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

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+3K120903Congruent Bone Plate System: Acu-Loc 2 PlateAcumed, LLC20126—
+3K113760Variax Superior and Anterior, Lateral and Midshaft Clavicle Plates Variax Aiming Blocks…Howmedica Osteonics Corp., Dba Stryker Orthopaedics201240—
+3K120015Osteomed Wrist Plating SystemOsteomed LP20122—
+3K113762Checkmate Metatarso-Phalangeal (MTP) Arthrodesis SystemArthrosurface, Inc.20121—
+3K113318Acute Innovations Modular Ribloc SystemAcute Innovations, LLC201281
+3K110895Ortho Solutions Trauma Implants for OsteosynthesisOrtho Solutions Limited20118—
+3K110086Ifs Profile Plates, Screws, and WashersInternal Fixation Systems, Inc.20115—
+3K110670VLP Foot Talus Plates, VLP Percutaneous Calcaneus Plates and Misc VLP Bone Screws…Smith & Nephew, Inc.201169—
+3K111326Osteowedge Opening Wedge Bone Locking SystemGraham Medical Technologies, LLC20111—
+3K110322Olecra Intramedullary Fixation SystemMylad Orthopedic Solutions20110—
+3K1032432.4MM VA-LCP Intercarpal Fusion SystemSynthes (Usa)2011187
+3K093868I.T.S. LRS Locking Reconstruction SystemI.T.S. Implantat-Technologie-Systeme GmbH201011
+3K100176Ascension Ankle Fusion Plate SystemAscension Orthopedics, Inc.201056—
+3K100325Peri-Loc Locking Hole Inserts and Cable AccessoriesSmith & Nephew, Inc.201038—
+3K092015Peri-Loc Periarticular Locked Plating SystemSmith & Nephew, Inc.2009411
+3K083286Orthopediatrics Pediloc Locking Plate SystemOrthoPediatrics Corp.2009605
+3K083032Peri-Loc Bone Plating and Screw SystemSmith & Nephew, Inc.2009772
+3K082516Peri-Loc Periarticular Locked Plating System Hexalobular Bone ScrewsSmith & Nephew, Inc.200887—
+3K081106Peri-Loc Periarticular Locked Plating System Volar Distal Radius Locking Plate for the…Smith & Nephew, Inc.200834—
+3K071563Peri-Loc Periarticular Locked Plating SystemSmith & Nephew, Inc.2007495—
+3K063166I.T.S. Pelvic Reconstruction SystemI.T.S. Implantat-Technologie-Systeme GmbH200692
+3K061352Peri-Loc Periarticular Locked Plating System for the Upper ExtremitySmith & Nephew, Inc.2006108—
+3K060041Trimed Bone PlatesTriMed, Inc.2006263
+3K030881Avanta Carpal Fusion Plating SystemAvanta Orthopaedics, Inc.20030—
+4K262975Arthrex Beaming SystemArthrex, Inc.20260—
+4K262618Arthrex Spine Compression FT ScrewArthrex, Inc.20260—
+4K262537Versalock Sterile Plating SystemGM Dos Reis Industria e Comercio Ltda.20260—
+4K261511Xpert AnkleNewclip Technics20260—
+4K260761APTUS Clavicle System 2.8Medartis AG20260—
+4K260054I.T.S. PRS Phoenix III.T.S. GmbH20260—
+4K260274Airlock® Ankle Plating SystemNovastep SAS20260—
+4K254093DePuy Synthes VOLT™ Medial Distal Femur 3.5 Plating SystemSynthes GmbH20260—
+4K260069DePuy Synthes VOLT™ Proximal Tibia 3.5 Plating SystemSynthes GmbH20260—
+4K254182AsterOsteonic Co., Ltd.20260—
+4K252191BRUSIO Trauma Toolbox System; TAMINA 3.5mm Proximal Humerus SystemBonebridge AG20250—
+4K252758Cannulated Screw and Kirschner (K wire) SystemOrthonovis, Inc.20250—
+4K251892MAXXOS P.A.C.E. Foot & Ankle Plating SystemMaxxos Medical GmbH20250—
+4K252019CurvaFix Low Profile SystemCurvafix, Inc.20250—
+4K252356The Acumed Wrist Fixation System - 2.4mm ScrewsAcumed, LLC20250—
+4K251161ANTHEM® Fracture SystemGlobus Medical, Inc.20250—
+4K243905Stitch Cerclage – Suture TapesGM Dos Reis Industria e Comercio Ltda.20250—
+4K251361Tyber Medical Distal Radius Plating SystemTyber Medical, LLC20250—
+4K250251Eleganz Fusion Screw System (Fusion Screw System)Dev420250—
+4K243963Pediatric Plating Platform HipOrthoPediatrics Corp.20250—
+4K243987TriMed Elbow and Forearm SystemTriMed, Inc.20251—
+4K243999TriMed Ankle Fixation SystemTriMed, Inc.20252—
+4K241666EVOS Pelvic and Acetabular SystemSmith & Nephew20250—
+4K241599Signature Osteosynthesis Plate SystemSignature Orthopaedic Pty, Ltd.20250—
+4K243658TMC Compression Implant SystemTreace Medical Concepts20242—
+4K242939ARTFX Trauma Bone Plate and Screw SystemArtfx Medical20242—
+4K241128TDM Plate and Screw SystemTdm Co., Ltd.20240—
+4K242596Versalock Mini and Micro Plating SystemGM Dos Reis Industria e Comercio Ltda.20242—
+4K242079Arthrex Elbow Fracture Plating SystemArthrex, Inc.20240—
+4K242995OIC Small / Mini Fragment Plate SystemThe Orthopaedic Implant Company20240—
+4K241387CoLink NeoFuse MIS Plating System (see attached parts list)In2bones USA20240—
+4K242055Freefix Forearm Plating SystemSkeletal Dynamics, Inc.20240—
+4K234059Forma Medical Optimal Plating SystemForma Medical, Inc.20240—
+4K240613APTUS Elbow Dorsal Olecranon PlatesMedartis AG20244—
+4K232115TDM Large Bone Plate and Screw SystemTdm Co., Ltd.20240—
+4K234040TriMed Threaded Intramedullary Nail SystemTriMed, Inc.202402
+4K233154SkyOPS™ Orthopedic Plate SystemSky Surgical, LLC20231—
+4K233396Cannulated Screw SystemSmith & Nephew, Inc.20230—
+4K233017TM Plating SystemTyber Medical, LLC20231—
+4K231887ARIX Ankle Distal Tibia SystemJeil Medical Corporation20231—
+4K232755Arthrex FiberTape and TigerTape Cerclage SuturesArthrex, Inc.20232—
+4K231649Intraosseous Fusion Device SystemAuxano Medical, LLC20230—
+4K230976Arthrex Radiopaque FiberTape Cerclage suturesArthrex, Inc.20231—
+4K231236IBS-B MIS Beveled Screw SystemIn2bones USA, LLC20231—
+4K230971APTUS® 3.5 TriLock Straight PlatesMedartis AG20232—
+4K230749TriMed Threaded Intramedullary Nail SystemTriMed, Inc.20231—
+4K223853Medartis APTUS® Ulna PlatesMedartis AG20235—
+4K221150Advanced Bone PlateDouble Medical Technology, Inc.20231—
+4K223118OIC Variable Angle Small Fragment Locking Plate SystemOrthopaedic Implant Company20231—
+4K221090Metal Cannulated ScrewDouble Medical Technology, Inc.20230—
+4K221412ARIX Rib SystemJeil Medical Corporation20221—
+4K210935I.T.S. Pelvic Reconstruction System (PRS RX & PRS Phoenix)I.T.S. GmbH202231
+4K220901S-Core Implant SystemSubchondral Solutions, Inc.20220—
+4K221362Omni Foot and Ankle Plating SystemExremity Medical, LLC20220—
+4K220199AFFINITY Proximal Tibia SystemTechfit Digital Surgery, Inc.20220—
+4K213591ANTHEM® Fracture SystemGlobus Medical, Inc.20225—
+4K212594OSSIOfiber® StapleOSSIO, Ltd.20222—
+4K212581VariAx 2 Distal Radius System, VariAx 2 Distal Ulna SystemStryker GmbH20224—
+4K203773BRM TOOL ScrewsBrm Extremities Srl20221—
+4K213069CoLink NeoFuse Plating SystemIn2bones USA, LLC20211—
+4K213214Xpert WristNewclip Technics20210—
+4K212640Stratum® Ankle Fusion Plating SystemNextremity Solutions, Inc.20210—
+4K212433Anthem Fracture SystemGlobus Medical, Inc.20217—
+4K212297Omni Foot and Ankle Plating SystemExtremity Medical, LLC20211—
+4K210159IntraLock SystemFusion Orthopedics, LLC20210—
+4K211592Avanti Orthopaedics Ulnar Shortening SystemAvanti Orthopaedics, Inc.20211—
+4K203834Arthrex Patella SuturePlatesArthrex, Inc.20211—
+4K203294Arthrex Pilon Fusion SystemArthrex, Inc.20212—
+4K203405EVOS Large Fragment Plating SystemSmith & Nephew, Inc.20213—
+4K202764Ortho Solutions Plating SystemOrtho Solutions UK, Ltd.20201—
+4K202307Activ FuseNewclip Technics20200—
+4K201918EVOS Large Fragment Plating SystemSmith & Nephew, Inc.202044
+4K201149CoLink Plating SystemIn2bones USA, LLC20200—
+4K200701Skeletal Dynamics Midshaft Humerus Plating SystemSkeletal Dynamics, Inc.20200—
+4K200762CoLink Cfx Plating SystemIn2bones USA, LLC20201—
+4K191995S4 Screw SystemSubchondral Solutions, Inc.20202—