510(k) Report

Devices descending from K043185

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

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+3K260809Arthrex Sterile VAL and VAL KreuLock™ Compression Screw SystemArthrex, Inc.20260—
+3K254215Arthrex Beaming SystemArthrex, Inc.20261—
+3K260323OrthoPediatrics® Locking Cannulated Blade Plate SystemOrthoPediatrics Corp.20260—
+3K252699CoAptix S SystemUniversity of Utah, Department of Orthopaedics20260—
+3K260390Super Upper Limbs Versalock Plating SystemGM Dos Reis Industria e Comercio Ltda.20261—
+3K253906Xpert HandNewclip Technics20260—
+3K254093DePuy Synthes VOLT™ Medial Distal Femur 3.5 Plating SystemSynthes GmbH20260—
+3K260069DePuy Synthes VOLT™ Proximal Tibia 3.5 Plating SystemSynthes GmbH20260—
+3K260361Treace Medical Concepts (TMC) Screw Fixation SystemTreace Medical Concepts, Inc.20260—
+3K253488iFuse INTRA Ti™ Implant SystemSI-BONE, Inc.20260—
+3K253713Arthrex Variable Angle (VA) Proximal Tibia Plating SystemArthrex, Inc.20260—
+3K252807Arthrex Anatomic Lapidus Plates and I-Beam Lapidus PlatesArthrex, Inc.20260—
+3K252191BRUSIO Trauma Toolbox System; TAMINA 3.5mm Proximal Humerus SystemBonebridge AG20250—
+3K252600Pediatric Plating Platform I Small-MiniOrthoPediatrics Corp.20250—
+3K252758Cannulated Screw and Kirschner (K wire) SystemOrthonovis, Inc.20250—
+3K251913OsteoCentric® UnifiMI® TCS Plating SystemOsteoCentric Technologies20250—
+3K250867Dunamis Screw and Suture Locking SystemDunamis Medical, LLC20250—
+3K251361Tyber Medical Distal Radius Plating SystemTyber Medical, LLC20250—
+3K243368Montblanc Plate SystemMedifield Medical Co., Ltd.20250—
+3K250920Arthrex Spine Compression FT ScrewArthrex, Inc.20251—
+3K243963Pediatric Plating Platform HipOrthoPediatrics Corp.20250—
+3K243943TriMed® Compression ScrewsTriMed, Inc.20252—
+3K241666EVOS Pelvic and Acetabular SystemSmith & Nephew20250—
+3K241599Signature Osteosynthesis Plate SystemSignature Orthopaedic Pty, Ltd.20250—
+3K243740Versalock Upper Limb Plating SystemGM Dos Reis Industria e Comercio Ltda.20251—
+3K242939ARTFX Trauma Bone Plate and Screw SystemArtfx Medical20242—
+3K242998GMReis Ankle Plating SystemGM Dos Reis Industria e Comercio Ltda.20241—
+3K242596Versalock Mini and Micro Plating SystemGM Dos Reis Industria e Comercio Ltda.20242—
+3K242399Bonebridge Osteosynthesis Plating SystemBonebridge AG20241—
+3K242415TMC Compression Implant SystemTreace Medical Concepts20243—
+3K241504iFuse TORQ TNT™ Implant SystemSI-BONE, Inc.20240—
+3K230546SignexOsteonic Co., Ltd.20242—
+3K240212COGNiTiON™ Staple SystemOrtho Solutions UK, Ltd.20240—
+3K230507Zimed Distal Medial Tibial Plate and Screw SystemZimed Medikal20240—
+3K233396Cannulated Screw SystemSmith & Nephew, Inc.20230—
+3K233017TM Plating SystemTyber Medical, LLC20231—
+3K231272OSSIOfiber® Pin Product Family, OSSIOfiber® Compression Screw, OSSIOfiber® Trimmable…OSSIO, Ltd.20233—
+3K223150APS Metal Plate & Screw SystemA Plus Biotechnology Co., Ltd.20230—
+3K222665Medline UNITE® Ankle Fusion Plating SystemMedline Industries, Inc.20230—
+3K222967Avanti Orthopaedics 2.2mm and 2.7mm Cannulated Screws, Avanti Orthopaedics 3.2mm and…Avanti Orthopaedics, Inc.20221—
+3K222267Arthrex 2.4 mm Volar Distal Radius Plate SystemArthrex, Inc.20221—
+3K222244Arthrex 3.5 mm Locking Compression PlatesArthrex, Inc.20221—
+3K220839Arthrex Compression FT PinsArthrex, Inc.20220—
+3K221485Arthrex FiberTape and TigerTape Cerclage SuturesArthrex, Inc.20225—
+3K213614Cannulated ScrewsMaxxion Medical, LLC20220—
+3K220319Asnis III Cannulated Screw System, Asnis PRO Cannulated Screw SystemStryker GmbH20221—
+3K213837Arthrx Fracture PlatesArthrex, Inc.20220—
+3K212348ALPHALOK™ Plating SystemVilex, LLC20223—
+3K212755SIGNUS SACRONAIL® Transsacral Stabilization SystemSignus Medizintechnik GmbH20220—
+3K211783TriMed Threaded Intramedullary Nail SystemTriMed, Inc.20212—
+3K200575Truemed Hand, Foot and Ankle Plates SystemTruemed Group, LLC20210—
+3K210994Arthrex Beveled FT ScrewsArthrex, Inc.20210—
+3K210754Cannulated Fasteners and NutsOsteoCentric Technologies20213—
+3K203405EVOS Large Fragment Plating SystemSmith & Nephew, Inc.20213—
+3K203239Arthrex Low Profile ScrewsArthrex, Inc.20200—
+3K201918EVOS Large Fragment Plating SystemSmith & Nephew, Inc.202044
+3K202912ARIX Ankle Distal Tibia SystemJeil Medical Corporation20201—
+3K201677Arthrex Mesh PlatesArthrex, Inc.20202—
+3K193660OSSIOfiber™ Compression ScrewsOSSIO, Ltd.20206—
+3K200226RetroFixRetrofix Screws, LLC20200—
+3K200701Skeletal Dynamics Midshaft Humerus Plating SystemSkeletal Dynamics, Inc.20200—
+3K200043Field Orthopaedics Bony Trauma Extremity System (BTES) Plate Range and Plate Screws…Field Orthopaedics Pty, Ltd.20201—
+3K192619Pitkar Locked Plating SystemS.H.Pitkar Orthotools Pvt., Ltd.20200—
+3K192096Omnia Medical Trauma ScrewsOmnia Medical, LLC20200—
+3K182718Mini and Micro Fragments Reconstruction System – GMReisGm Dos Reis Industria E Comerico Ltda.20194—
+3K190391TDM Plate and Screw SystemsTdm Co., Ltd.20191—
+3K192181PRECICE Plating SystemNuvasive Specialized Orthopedics, Inc.201921
+3K190830TDM Screw SystemsTdm Co., Ltd.20191—
+3K190992OrthoPediatrics PediFoot Deformity Corrections SystemOrthoPediatrics Corp.20190—
+3K182361Arthrex Compression FT ScrewsArthrex, Inc.20184—
+3K182148SILVERBACK Gorilla Plating SystemParagon 28, Inc.20183—
+3K171808TDM Plate and Screw SystemTdm Co., Ltd.20186—
+3K173293EVOS Small Fragment Upper Extremity PlatesSmith & Nephew, Inc.201812—
+3K172973Life Spine Foot and Ankle Plating SystemLife Spine, Inc.20170—
+3K172886Breakaway Screw SystemParagon 2820174—
+3K173121Ankle Fusion Plating SystemIn2bones Sas20172—
+3K172260Omni Foot Plating SystemExtremity Medical, LLC20174—
+3K170704The Locking Pediatric Osteotomy Plate (LolliPOP) SystemPega Medical, Inc.20170—
+3K162171S4 Screw System™Subchondral Solutions20173—
+3K170547Arthrex Mesh Plate SystemArthrex, Inc.201715—
+3K172262EVOS Small Fragment Plating SystemSmith & Nephew, Inc.20179—
+3K170038FuzeFix Screw SystemFusion Orthopedics, LLC20171—
+3K170518In2Bones Fracture and Correction SystemIn2bones USA, LLC2017151
+3K163593Additive Orthopaedics Bunion SystemAdditive Orthopaedics, LLC20170—
+3K170693Phantom Small Bone Intramedullary Nail SystemParagon 28, Inc.20179—
+3K162674BioPro Foot Plating SystemsBiopro, Inc.201719—
+3K170382Arthrex Compression ScrewsArthrex, Inc.20173—
+3K170887EVOS Small Fragment Plating SystemSmith & Nephew, Inc.201713—
+3K170214Additive Orthopaedics Locking Lattice PlateAdditive Orthopaedics, LLC20178—
+3K163361ANTHEM™ Fracture SystemGlobus Medical, Inc.201714—
+3K170040BePOD Cannulated Arthrodesis ScrewsFournitures Hospitalieres Industrie20170—
+3K163425NMUC Brand Small And Large Fragment Osteosynthesis Plating System, NMUC Brand of DHS/DCS…Narang Medical USA Corporation20170—
+3K163489OrthoSolutions 'System26' Bone ScrewsOrtho Solutions UK Limited201731
+3K162307OrthoPediatrics Locking Proximal Femur System Cortical ScrewsOrthoPediatrics Corp.20161—
+3K160633G3(TM) Active Plate (R) Small Fragment SystemGenesis Fracture Care, Inc.20160—
+3K152548AXI+LINE Proximal Bunion Correction SystemNextremity Solutions, Inc.20150—
+3K151732Arthrex Fracture PlatesArthrex, Inc.201521—
+3K151407RECON systemNormed Medizin-Technik GmbH20154—
+3K150675Dorsal Spanning PlateSkeletal Dynamics, LLC20151—
+3K150456Arthrex Plates, Screws, and StaplesArthrex, Inc.20156—