510(k) Report

Devices descending from K050636

544 later devices reach Synthes 3.0MM Headless Compression Screws through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K223761OIC Intramedullary Screw SystemOrthopaedic Implant Company20230—
+1K191771SECURE ScrewA.M. Surgical, Inc.20190—
+1K190830TDM Screw SystemsTdm Co., Ltd.20191—
+1K183603INnate Cannulated Screw SystemExsomed Corporation20195—
+1K171628HBS2 Headless Bone ScrewStuckenbrock Medizintechnik GmbH20180—
+1K171558ExsoMed ITN Cannulated Screw SystemExsomed Holdings Company, LLC20177—
+1K162874Cannulated Screws NeoorthoNeoortho Produtos Ortopedicos S/A20170—
+1K161894SurgTech Trauma SystemSurgtech, Inc.20173—
+1K161616DePuy Synthes 4.0 mm and 4.5 mm Cortex Screws, DePuy Synthes 2.4 mm Cannulated Screws…Synthes USA Products, LLC201733—
+1K161259KLS Martin Cannulated Headless ScrewsKLS Martin L.P.20162—
+1K160427dynaMX (TM) Nitinol Compression ScrewMx Orthopedics, Corp.20162—
+1K143596Miniars ScrewsOvermed Srl.20160—
+1K124027Monster Screw SystemApogee Orthosolutions201341—
+1K121277Z-Snap Off Screw, Z-Double Thread Compression Screw, Z-Guide Wire, Z-StapleZ-Medical GmbH & Co. KG201224—
+1K112737Tiger Headless Cannulated ScrewsTrilliant Surgical, Ltd.2011124
+1K110658Aptus Cannulated Compression ScrewsMedartis AG201112—
+1K090675Smith & Nephew, Inc. VLP Foot Plating, Screw System and AccessoriesSmith & Nephew, Inc.2009487—
+1K081011Arex Scru 2 Headless Compression Screws, Models: P2P10, P2P15, P2P20, P2P25, P2P30…Arex USA20081—
+1K081934Extremity Medical Compression ScrewExtremity Medical, LLC200868—
+2K260277Mikron Trauma Bone Plate& Screw SystemMikron Makina San. ve Tic. Ltd. Sti.20260—
+2K252699CoAptix S SystemUniversity of Utah, Department of Orthopaedics20260—
+2K260291Vortex5 Tailor's Bunion Correction SystemNvision Biomedical Technologies, Inc.20260—
+2K253488iFuse INTRA Ti™ Implant SystemSI-BONE, Inc.20260—
+2K252312Eleganz IM Threaded Nail System (IM Threaded Nail System)Dev420250—
+2K242988Genostis Osteosynthesis SystemGenostis AF20250—
+2K243943TriMed® Compression ScrewsTriMed, Inc.20252—
+2K242939ARTFX Trauma Bone Plate and Screw SystemArtfx Medical20242—
+2K241504iFuse TORQ TNT™ Implant SystemSI-BONE, Inc.20240—
+2K241018KLS Martin Orthopedic Implants - MR ConditionalKLS-Martin L.P.20241—
+2K231860TDM Screw SystemTdm Co., Ltd.20240—
+2K233396Cannulated Screw SystemSmith & Nephew, Inc.20230—
+2K231272OSSIOfiber® Pin Product Family, OSSIOfiber® Compression Screw, OSSIOfiber® Trimmable…OSSIO, Ltd.20233—
+2K232251APTUS Cannulated Compression Screws Line Extension, APTUS K-Wire System Line ExtensionMedartis AG20231—
+2K232387Treace Medical Concepts (TMC) Compression Implant SystemTreace Medical Concepts20234—
+2K230867Bone Bolt SystemUniversity of Utah, Department of Orthopaedics20230—
+2K230744Acumed Acutrak 3 Headless Compression Screw SystemAcumed, LLC20231—
+2K221090Metal Cannulated ScrewDouble Medical Technology, Inc.20230—
+2K222799Haymaker® Screw SystemOrthocircle Spine D.B.A. OC Medical Devices20230—
+2K221333Acumed Acutrak System- MR Conditional, Acumed Acturak 2 System- MR ConditionalAcumed, LLC202204
+2K221342REDEMPTION Beaming SystemVilex, LLC20220—
+2K222967Avanti Orthopaedics 2.2mm and 2.7mm Cannulated Screws, Avanti Orthopaedics 3.2mm and…Avanti Orthopaedics, Inc.20221—
+2K222645Treace Medical Concepts (TMC) Implant Fixation SystemTreace Medical Concepts20226—
+2K213126Smith & Nephew, Inc. Plates and Screws Systems: EVOS, Peri-Loc, D-Rad, TC-100, VLP…Smith & Nephew, Inc.202221
+2K221362Omni Foot and Ankle Plating SystemExremity Medical, LLC20220—
+2K212755SIGNUS SACRONAIL® Transsacral Stabilization SystemSignus Medizintechnik GmbH20220—
+2K211435PAO Cortical ScrewMedacta International S.A.20210—
+2K210837Smith & Nephew Plates and ScrewsSmith & Nephew, Inc.202171
+2K210157SOLE Medial Column Fusion PlateOrthofix Srl20210—
+2K202589APTUS Cannulated Compression Screws, APTUS headed Cannulated Compression Screws, APTUS…Medartis AG202061
+2K200987LTJ Screws and WasherAzurmeds, Inc.20201—
+2K193660OSSIOfiber™ Compression ScrewsOSSIO, Ltd.20206—
+2K201556Intraosseous Fixation SystemExtremity Medical, LLC20200—
+2K201430InFrame™ Cannulated Fixation SystemExsomed Corp.20201—
+2K200259Headless Compression Screw SystemOsteocentric Extremities, LLC20200—
+2K200043Field Orthopaedics Bony Trauma Extremity System (BTES) Plate Range and Plate Screws…Field Orthopaedics Pty, Ltd.20201—
+2K192096Omnia Medical Trauma ScrewsOmnia Medical, LLC20200—
+2K192745DePuy Synthes Trauma ScrewsSynthes (Usa) Products, LLC / Depuy Orthopaedics, Inc.20195—
+2K191817ActivOrtho Continuous Compression Screw SystemActivortho, Inc.20190—
+2K190586Monster® Screw SystemParagon 28, Inc.201921—
+2K181610ActivOrtho Nitinol Compression Screw SystemActivortho, Inc.20191—
+2K181898Two-Step Implant SystemTrilliant Surgical20180—
+2K180554ANTHEM Fracture SystemGlobus Medical, Inc.201810—
+2K173693Orbitum Bone Staple Implant, X and VIOrthovestments, LLC20180—
+2K172205ExoToe StapleExotoe, LLC20180—
+2K172617Treace Medical Concepts (TMC) Compression Screw SystemTreace Medical Concepts, Inc.201711—
+2K162153Integra® CAPTURE™ Screw System & Integra® Ti6® Internal Fixation SystemAscension Orthopedics20171—
+2K160553DePuy Synthes 4.0 mm and 5.0 mm Locking Screws – MR Conditional, DePuy Synthes Wrist…Synthes (Usa) Products, LLC / Depuy Orthopaedics, Inc.20170—
+2K162674BioPro Foot Plating SystemsBiopro, Inc.201719—
+2K160191Align Anterior Ankle Fusion PlateExtremity Medical, LLC20165—
+2K153338Tiger Cannulated Screw SystemTrilliant Surgical, Ltd.201674
+2K151160Arcus Staple SystemNextremity Solutions, Inc.20151—
+2K151407RECON systemNormed Medizin-Technik GmbH20154—
+2K151418Monster Screw SystemParagon 28201527—
+2K143039CrossRoads Screw SystemOrthodiscovery Group, LLC (D.B.A. Crossroads Extrem201579—
+2K140792Salvation 3DI Plating SystemWrightmedicaltechnologyinc201421
+2K140408Salvation Osteopenic ScrewWrightmedicaltechnologyinc20141—
+2K140814Evos Mini-Fragment Plating SystemSmith & Nephew, Inc.2014322
+2K133930Flower Rear Foot Plating Set, Flower Calcaneus Planting Set, Flower Rearfoot Plating SetFlower Orthopedics Corporation201406
+2K132886Smith & Nephew Variable-Angle Locking Mini-Fragment Plating SystemSmith & Nephew, Inc.2014462
+2K133460Aptus Cannulated Compression ScrewsMedartis AG20138—
+2K131061Restore Bunion Correction SystemNextremity Solutions201315—
+2K130627Swing-Off ScrewAdvanced Interventional Technology, LLC20130—
+2K131722I.T.S. Extremity Fixation SystemsI.T.S. GmbH2013242
+2K130479Ilizarov Drill Tip WiresSmith & Nephew, Inc.20136—
+2K123055Smith & Nephew, Inc Screw and Plate System InstrumentationSmith & Nephew, Inc.201333—
+2K122334Checkmate Small Bone Fusion SystemArthrosurface, Inc.20125—
+2K111994Smith & Nephew Cannulated Screws and WashersSmith & Nephew, Inc.2011161—
+2K110670VLP Foot Talus Plates, VLP Percutaneous Calcaneus Plates and Misc VLP Bone Screws…Smith & Nephew, Inc.201169—
+2K101700IO Fix Hand, IO Fix Foot, Extremity Medical Screw SystemExtremity Medical, LLC2010562
+2K093047Smith & Nephew Circular Fixation SystemSmith & Nephew, Inc.2010511
+2K100776Synthes 2.4 MM/2.7 MM Variable Angle LCP Forefoot/Midfoot SystemSynthes (Usa)2010228—
+2K082934Extremity Medical Midfoot Screw SystemExtremity Medical, LLC200963—
+3K260995DynaNail Helix® Fixation SystemMedShape, Inc.20260—
+3K261830FRAXION 3.5 Plate System (Various - See Catalog);FRAXION 4.5 Plate System (Various - See…Ortler Global Tibbi Gerecler Anonim Sirketi20260—
+3K262344Large Compression ScrewsTriMed, Inc.20260—
+3K260958I.T.S. Clavicle Plates with Angular Stability; I.T.S. Volar Radius Plate with Angular…I.T.S. GmbH20260—
+3K261241TriMed Compression ScrewsTriMed, Inc.20260—
+3K261145Avanti Distal Elbow ORIF SystemAvanti Orthopaedics, LLC20260—
+3K254077OSSIOfiber® Threaded Trimmable Fixation NailOSSIO, Ltd.20260—
+3K260934TITAN Nail; APTUS K-Wire SystemMedartis AG20260—