510(k) Report

Devices descending from K043185

405 later devices reach Synthes 3.5MM Cortex Screws through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+3K143385Acumed Ankle Plating SystemAcumed, LLC201523—
+3K143749Arthrex Distal Radius SystemArthrex, Inc.20152—
+3K143061Activ Ankle Locking Plating SystemNewclip Technics20158—
+3K143139Arthrex Fracture SystemArthrex, Inc.20151—
+3K142057Infix Cannulated Screw SystemInfix Medical, LLC20151—
+3K142938G3 Active Plate Large Fragment SystemGenesis Fracture Care, Inc.20143—
+3K141347Emerge Medical IM Nail SystemEmerge Medical20140—
+3K141735Arthrex Ankle Fusion Plating SystemArthrex, Inc.2014381
+3K141784Ortho Solutions Ultos Plating SystemOrtho Solutions Limited2014282
+3K141121Axsos 3 TI Locking Plate SystemStryker Trauma AG201426—
+3K140357Oic Variable Angle Small Fragment Locking Plate SystemOrthopaedic Implant Company20142—
+3K140814Evos Mini-Fragment Plating SystemSmith & Nephew, Inc.2014322
+3K132886Smith & Nephew Variable-Angle Locking Mini-Fragment Plating SystemSmith & Nephew, Inc.2014462
+3K132296D-Rad Smart PackSmith & Nephew, Inc.2014114
+3K133102Flower Ankle Plating SetFlower Orthopedics Corporation20130—
+3K131722I.T.S. Extremity Fixation SystemsI.T.S. GmbH2013242
+3K131620Jones-FX Fracture SystemInstratek, Inc.20131—
+3K122334Checkmate Small Bone Fusion SystemArthrosurface, Inc.20125—
+3K110271Maestro Wrist Plating SystemBiomet Manufacturing Corp20110—
+4K262975Arthrex Beaming SystemArthrex, Inc.20260—
+4K262618Arthrex Spine Compression FT ScrewArthrex, Inc.20260—
+4K261830FRAXION 3.5 Plate System (Various - See Catalog);FRAXION 4.5 Plate System (Various - See…Ortler Global Tibbi Gerecler Anonim Sirketi20260—
+4K262537Versalock Sterile Plating SystemGM Dos Reis Industria e Comercio Ltda.20260—
+4K262344Large Compression ScrewsTriMed, Inc.20260—
+4K261511Xpert AnkleNewclip Technics20260—
+4K260958I.T.S. Clavicle Plates with Angular Stability; I.T.S. Volar Radius Plate with Angular…I.T.S. GmbH20260—
+4K261207Exalta Proximal Tibia Plating SystemTyber Medical, LLC20260—
+4K261241TriMed Compression ScrewsTriMed, Inc.20260—
+4K261145Avanti Distal Elbow ORIF SystemAvanti Orthopaedics, LLC20260—
+4K254077OSSIOfiber® Threaded Trimmable Fixation NailOSSIO, Ltd.20260—
+4K260228POYA 3.5mm Medial Proximal Tibia SystemBonebridge AG20260—
+4K254182AsterOsteonic Co., Ltd.20260—
+4K254162KLS Martin Ixos SystemKLS Martin L.P.20260—
+4K251892MAXXOS P.A.C.E. Foot & Ankle Plating SystemMaxxos Medical GmbH20250—
+4K251161ANTHEM® Fracture SystemGlobus Medical, Inc.20250—
+4K243905Stitch Cerclage – Suture TapesGM Dos Reis Industria e Comercio Ltda.20250—
+4K250251Eleganz Fusion Screw System (Fusion Screw System)Dev420250—
+4K243999TriMed Ankle Fixation SystemTriMed, Inc.20252—
+4K243658TMC Compression Implant SystemTreace Medical Concepts20242—
+4K241128TDM Plate and Screw SystemTdm Co., Ltd.20240—
+4K242995OIC Small / Mini Fragment Plate SystemThe Orthopaedic Implant Company20240—
+4K240487EVOS Patella PlatesSmith & Nephew20240—
+4K241387CoLink NeoFuse MIS Plating System (see attached parts list)In2bones USA20240—
+4K241277OSSIOfiber® Threaded Trimmable Fixation NailOSSIO, Ltd.20241—
+4K232115TDM Large Bone Plate and Screw SystemTdm Co., Ltd.20240—
+4K233912ARIX Cannulated Screw SystemJeil Medical Corporation20240—
+4K233198OSSIOfiber® Threaded Trimmable Fixation NailsOSSIO, Ltd.20242—
+4K231860TDM Screw SystemTdm Co., Ltd.20240—
+4K234040TriMed Threaded Intramedullary Nail SystemTriMed, Inc.202402
+4K231684Quick - Radius Disposable SetGM Dos Reis Industria e Comercio Ltda.20240—
+4K233154SkyOPS™ Orthopedic Plate SystemSky Surgical, 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—
+4K222381PeriPRO™ Femur System, Variable Angle Fixation System, AxSOS 3Ti, Stryker Plating SystemStryker GmbH20238—
+4K230204ALPHALOK Plating SystemVilex, LLC20230—
+4K230749TriMed Threaded Intramedullary Nail SystemTriMed, Inc.20231—
+4K230118Bony Trauma Extremity System (BTES) Screw Range, NX NailField Orthopaedics Pty, Ltd.20230—
+4K223118OIC Variable Angle Small Fragment Locking Plate SystemOrthopaedic Implant Company20231—
+4K221193OSSIOfiber Compression Screw, OSSIOfiber Compression Screw, 6.5mmOSSIO, Ltd.20224—
+4K221558ALPHALOK Plating SystemVilex, LLC20222—
+4K210935I.T.S. Pelvic Reconstruction System (PRS RX & PRS Phoenix)I.T.S. GmbH202231
+4K220901S-Core Implant SystemSubchondral Solutions, Inc.20220—
+4K221395Footmotion Plating SystemNewclip Technics20220—
+4K220937Arthrex Mini Fragment SystemArthrex, Inc.20222—
+4K220244DVR® Crosslock Wrist Spanning Plate (131849181)Pioneer Surgical Technology, Inc D.B.A Resolve Surgical Tech20220—
+4K212601DRPx Locking Distal Radius Plate SystemOrthopaedic Implant Company20220—
+4K203773BRM TOOL ScrewsBrm Extremities Srl20221—
+4K213596OSSIOfiber Compression Screw, 3.5mmOSSIO, Ltd.20214—
+4K213069CoLink NeoFuse Plating SystemIn2bones USA, LLC20211—
+4K213214Xpert WristNewclip Technics20210—
+4K212640Stratum® Ankle Fusion Plating SystemNextremity Solutions, Inc.20210—
+4K211290Cannulated Fasteners and NutsOsteoCentric Technologies20212—
+4K210159IntraLock SystemFusion Orthopedics, LLC20210—
+4K203834Arthrex Patella SuturePlatesArthrex, Inc.20211—
+4K203294Arthrex Pilon Fusion SystemArthrex, Inc.20212—
+4K202348External Remote Controller ERC 4PNuvasive Specialized Orthopedics, Inc.20200—
+4K202764Ortho Solutions Plating SystemOrtho Solutions UK, Ltd.20201—
+4K202307Activ FuseNewclip Technics20200—
+4K202496ANTHEM Fracture SystemGlobus Medical, Inc.20208—
+4K201527EVOS Straight Proximal Humerus 7-15 hole Plates (137-225mm)Smith & Nephew, Inc.20208—
+4K201149CoLink Plating SystemIn2bones USA, LLC20200—
+4K193617Precice® ScrewsNuvasive Specialized Orthopedics, Inc.20200—
+4K200762CoLink Cfx Plating SystemIn2bones USA, LLC20201—
+4K191995S4 Screw SystemSubchondral Solutions, Inc.20202—
+4K193222Tyber Medical Anatomical Plating SystemTyber Medical, LLC202011—
+4K193543CoLink Plating System, Fracture and Correction System, CoLink Mini Plating System…In2bones USA, LLC20200—
+4K190921Arthrex Low Profile ScrewsArthrex, Inc.20190—
+4K190953Arthrex Minimally Invasive Ankle Fusion PlateArthrex, Inc.20191—
+4K191412VariAx 2 System, VariAx 2 Mini Fragment SystemStryker GmbH201910—
+4K190385CoLink Plating System, Fracture and Correction System, RTS Implant System, NeoSpan…In2bones USA, LLC20190—
+4K191535CoLink® Mini Plating SystemIn2bones USA, LLC20196—
+4K182785LOQTEQ VA Foot Plates 2.5Aap Implantate AG20190—
+4K190253EVOS Small Fragment Upper Extremity Plates Line AdditionsSmith & Nephew, Inc.20199—
+4K182307Small Bone Phantom® Intramedullary Nail System; TTC Phantom® Intramedullary Nail SystemParagon 28, Inc.20198—
+4K183011Additive Orthopaedics Patient Specific 3D Locking Lattice PlatesAdditive Orthopaedics20195—
+4K180554ANTHEM Fracture SystemGlobus Medical, Inc.201810—
+4K180377Fracture and Correction SystemIn2bones USA, LLC20187—