510(k) Report

Devices descending from K100776

228 later devices reach Synthes 2.4 MM/2.7 MM Variable Angle LCP Forefoot/Midfoot System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+2K142418I.T.S. Hand Locking Plates System - HLSI.T.S. GmbH201411
+2K141992Variax 2 SystemStryker Trauma AG201422—
+2K133102Flower Ankle Plating SetFlower Orthopedics Corporation20130—
+2K122489Emerge Medical Solid Bone ScrewsEmerge Medical20121—
+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—
+3K261191Alians Elbow SNewclip Technics20260—
+3K261351SALGINA 2.5mm Distal Radius SystemBonebridge AG20260—
+3K260054I.T.S. PRS Phoenix III.T.S. GmbH20260—
+3K260228POYA 3.5mm Medial Proximal Tibia SystemBonebridge AG20260—
+3K252699CoAptix S SystemUniversity of Utah, Department of Orthopaedics20260—
+3K260353Arthrex Humeral Plating System (Anatomic Humeral Plate) and Cerclage ButtonArthrex, Inc.20260—
+3K253488iFuse INTRA Ti™ Implant SystemSI-BONE, Inc.20260—
+3K251913OsteoCentric® UnifiMI® TCS Plating SystemOsteoCentric Technologies20250—
+3K243943TriMed® Compression ScrewsTriMed, Inc.20252—
+3K243995Arthrex Humeral Plating System and Cerclage ButtonArthrex, Inc.20251—
+3K243999TriMed Ankle Fixation SystemTriMed, Inc.20252—
+3K243610APTUS Hand System; APTUS Elbow Dorsal OlecranonMedartis AG20252—
+3K241666EVOS Pelvic and Acetabular SystemSmith & Nephew20250—
+3K241599Signature Osteosynthesis Plate SystemSignature Orthopaedic Pty, Ltd.20250—
+3K241128TDM Plate and Screw SystemTdm Co., Ltd.20240—
+3K242348Locking Screw,CoCrMoDouble Medical Technology, Inc.20240—
+3K240487EVOS Patella PlatesSmith & Nephew20240—
+3K240318SITTER 3.5mm Versatile SystemBonebridge AG20244—
+3K241504iFuse TORQ TNT™ Implant SystemSI-BONE, Inc.20240—
+3K230507Zimed Distal Medial Tibial Plate and Screw SystemZimed Medikal20240—
+3K232652Anatomical Plating System (various)Tyber Medical, LLC2023320
+3K232693Tyber Medical Distal Radius Plating SystemTyber Medical, LLC20231—
+3K231272OSSIOfiber® Pin Product Family, OSSIOfiber® Compression Screw, OSSIOfiber® Trimmable…OSSIO, Ltd.20233—
+3K231649Intraosseous Fusion Device SystemAuxano Medical, LLC20230—
+3K230867Bone Bolt SystemUniversity of Utah, Department of Orthopaedics20230—
+3K230204ALPHALOK Plating SystemVilex, LLC20230—
+3K222465Tyber Medical Anatomical Plating SystemTyber Medical, LLC20239—
+3K230118Bony Trauma Extremity System (BTES) Screw Range, NX NailField Orthopaedics Pty, Ltd.20230—
+3K221090Metal Cannulated ScrewDouble Medical Technology, Inc.20230—
+3K222799Haymaker® Screw SystemOrthocircle Spine D.B.A. OC Medical Devices20230—
+3K222967Avanti Orthopaedics 2.2mm and 2.7mm Cannulated Screws, Avanti Orthopaedics 3.2mm and…Avanti Orthopaedics, Inc.20221—
+3K221558ALPHALOK Plating SystemVilex, LLC20222—
+3K221395Footmotion Plating SystemNewclip Technics20220—
+3K220319Asnis III Cannulated Screw System, Asnis PRO Cannulated Screw SystemStryker GmbH20221—
+3K212755SIGNUS SACRONAIL® Transsacral Stabilization SystemSignus Medizintechnik GmbH20220—
+3K213591ANTHEM® Fracture SystemGlobus Medical, Inc.20225—
+3K203773BRM TOOL ScrewsBrm Extremities Srl20221—
+3K213895Distal Humerus Plating SystemSkeletal Dynamics, Inc.20220—
+3K213214Xpert WristNewclip Technics20210—
+3K213036Treace Medical Concepts (TMC) Screw Fixation SystemTreace Medical Concepts, Inc.20217—
+3K203817Tyber Medical Anatomical Plating SystemTyber Medical, LLC202110—
+3K211783TriMed Threaded Intramedullary Nail SystemTriMed, Inc.20212—
+3K210754Cannulated Fasteners and NutsOsteoCentric Technologies20213—
+3K210658Volition Plating SystemOrtho Solutions UK, Ltd.20210—
+3K193660OSSIOfiber™ Compression ScrewsOSSIO, Ltd.20206—
+3K200226RetroFixRetrofix Screws, LLC20200—
+3K200701Skeletal Dynamics Midshaft Humerus Plating SystemSkeletal Dynamics, Inc.20200—
+3K193614FINE Osteotomy around the kneeBodycad Laboratories, Inc.20204—
+3K192619Pitkar Locked Plating SystemS.H.Pitkar Orthotools Pvt., Ltd.20200—
+3K192096Omnia Medical Trauma ScrewsOmnia Medical, LLC20200—
+3K190830TDM Screw SystemsTdm Co., Ltd.20191—
+3K183363Treace Medical Concepts (TMC) Snap-Off Screw SystemTreace Medical Concepts, Inc.20191—
+3K173641Activ AnkleNewclip Technics20183—
+3K171372Alians Elbow Locking Plating SystemNewclip Technics20180—
+3K172786MDS Plating SystemMiami Device Solutions, LLC20170—
+3K170843Alians Fragment SpecificNewclip Technics20171—
+3K170771VariAx 2 Foot SystemStryker GmbH20170—
+3K163425NMUC Brand Small And Large Fragment Osteosynthesis Plating System, NMUC Brand of DHS/DCS…Narang Medical USA Corporation20170—
+3K160177Gridlock Ankle Plating SystemTrilliant Surgical, Ltd.201631
+3K151708RECON system - Compression ScrewsNormed Medizin-Technik GmbH20160—
+3K151886Acumed Ankle and Small Fragment Base Set UpdateAcumed, LLC201515—
+3K152312RECON system-V-TEK-IVP Plates and ScrewsNormed Medizin-Technik GmbH201524
+3K151769Anchorage 2 CP SystemStryker GmbH20150—
+3K141347Emerge Medical IM Nail SystemEmerge Medical20140—
+4K262344Large Compression ScrewsTriMed, Inc.20260—
+4K261511Xpert AnkleNewclip Technics20260—
+4K260810Anteralign LS coverplateTyber Medical, LLC20260—
+4K260761APTUS Clavicle System 2.8Medartis AG20260—
+4K261241TriMed Compression ScrewsTriMed, Inc.20260—
+4K254077OSSIOfiber® Threaded Trimmable Fixation NailOSSIO, Ltd.20260—
+4K253916APTUS Shoulder Proximal Humerus System, PentaLock 3.5Medartis AG20260—
+4K251945TriMed Total Wrist Fusion System (Total Wrist Fusion Plate)TriMed, Inc.20251—
+4K242486Tyber Medical Anatomical Plating SystemTyber Medical, LLC20251—
+4K242671Treace Medical Concepts (TMC) Screw Fixation SystemTreace Medical Concepts, Inc.20241—
+4K233816REDEMPTION Charcot Plating SystemVilex, LLC20240—
+4K241277OSSIOfiber® Threaded Trimmable Fixation NailOSSIO, Ltd.20241—
+4K241218Tyber Medical Anatomical Plating SystemTyber Medical, LLC20242—
+4K233912ARIX Cannulated Screw SystemJeil Medical Corporation20240—
+4K233198OSSIOfiber® Threaded Trimmable Fixation NailsOSSIO, Ltd.20242—
+4K240173Treace Medical Systems (TMC) Plating SystemTreace Medical Concepts, Inc.202441
+4K231860TDM Screw SystemTdm Co., Ltd.20240—
+4K234040TriMed Threaded Intramedullary Nail SystemTriMed, Inc.202402
+4K233423Tyber Medical Anatomical Plating System – Line extension to the Mini-Frag SystemTyber Medical, LLC20232—
+4K233017TM Plating SystemTyber Medical, LLC20231—
+4K230946Accelerate Compression Screw System-Small Product Code ACC-S; Accelerate Compression…Trax Surgical20230—
+4K230749TriMed Threaded Intramedullary Nail SystemTriMed, Inc.20231—
+4K221193OSSIOfiber Compression Screw, OSSIOfiber Compression Screw, 6.5mmOSSIO, Ltd.20224—
+4K222820BRM TOOL Screws, BIOPLAN Subtalar ImplantBrm Extremities20220—
+4K212378Arsenal Ankle Plating SystemTrilliant Surgical20220—
+4K213596OSSIOfiber Compression Screw, 3.5mmOSSIO, Ltd.20214—
+4K211290Cannulated Fasteners and NutsOsteoCentric Technologies20212—
+4K211646FINE OsteotomyBodycad Laboratories, Inc.20213—
+4K202657Javelin Tailor's Bunion Fixation SystemNvision Biomedical Technologies, Inc.20201—
+4K191009Arsenal Plating SystemTrilliant Surgical20192—