510(k) Report

Devices descending from K080943

215 later devices reach Synthes 4.5 MM and 6.5 MM Headless Compression Screws through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K210146Cannulated Compression Device SystemOrthopedic Designs North America, Inc.20220—
+1K190830TDM Screw SystemsTdm Co., Ltd.20191—
+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—
+1K143165Herbert/Whipple Bone Screw System, Herbert/Whipple Bone Screw System, Herbert Cannulated…Zimmer, Inc.201572
+1K133451Fixos Screw SystemStryker Trauma AG20143—
+1K133460Aptus Cannulated Compression ScrewsMedartis AG20138—
+1K132248Flower Bone Screw SetFlower Orthopedics Corporation20131—
+1K131324Maxtorque Screw SystemOrthohelix Surgical Designs, Inc.20132—
+1K111994Smith & Nephew Cannulated Screws and WashersSmith & Nephew, Inc.2011161—
+2K260277Mikron Trauma Bone Plate& Screw SystemMikron Makina San. ve Tic. Ltd. Sti.20260—
+2K262075Lapidus Screw KitRelja Innovations, LLC20260—
+2K252699CoAptix S SystemUniversity of Utah, Department of Orthopaedics20260—
+2K253488iFuse INTRA Ti™ Implant SystemSI-BONE, Inc.20260—
+2K242988Genostis Osteosynthesis SystemGenostis AF20250—
+2K250935TriMed Fifth Metatarsal System (Fifth Metatarsal Plate); TriMed Fifth Metatarsal System…TriMed, Inc.20250—
+2K243943TriMed® Compression ScrewsTriMed, Inc.20252—
+2K242939ARTFX Trauma Bone Plate and Screw SystemArtfx Medical20242—
+2K241504iFuse TORQ TNT™ Implant SystemSI-BONE, Inc.20240—
+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—
+2K223468Nexis® compressive screwsNovastep20230—
+2K230867Bone Bolt SystemUniversity of Utah, Department of Orthopaedics20230—
+2K230053SimpliFix Hip SystemStabiliz Orthopaedics, Inc.20230—
+2K221090Metal Cannulated ScrewDouble Medical Technology, Inc.20230—
+2K222967Avanti Orthopaedics 2.2mm and 2.7mm Cannulated Screws, Avanti Orthopaedics 3.2mm and…Avanti Orthopaedics, Inc.20221—
+2K213126Smith & Nephew, Inc. Plates and Screws Systems: EVOS, Peri-Loc, D-Rad, TC-100, VLP…Smith & Nephew, Inc.202221
+2K220359Tandry Compression Screw SystemMicroware Precision Co., Ltd.20220—
+2K212755SIGNUS SACRONAIL® Transsacral Stabilization SystemSignus Medizintechnik GmbH20220—
+2K202326BESPA Charcot SystemBespa Global, LLC20210—
+2K211435PAO Cortical ScrewMedacta International S.A.20210—
+2K210837Smith & Nephew Plates and ScrewsSmith & Nephew, Inc.202171
+2K202589APTUS Cannulated Compression Screws, APTUS headed Cannulated Compression Screws, APTUS…Medartis AG202061
+2K193660OSSIOfiber™ Compression ScrewsOSSIO, Ltd.20206—
+2K200043Field Orthopaedics Bony Trauma Extremity System (BTES) Plate Range and Plate Screws…Field Orthopaedics Pty, Ltd.20201—
+2K193029Conquest FNSmith & Nephew, Inc.202010—
+2K192096Omnia Medical Trauma ScrewsOmnia Medical, LLC20200—
+2K192745DePuy Synthes Trauma ScrewsSynthes (Usa) Products, LLC / Depuy Orthopaedics, Inc.20195—
+2K182989AURORA™ Screw SystemMiRus, LLC20180—
+2K172785Conquest FNSmith & Nephew20178—
+2K172617Treace Medical Concepts (TMC) Compression Screw SystemTreace Medical Concepts, Inc.201711—
+2K160553DePuy Synthes 4.0 mm and 5.0 mm Locking Screws – MR Conditional, DePuy Synthes Wrist…Synthes (Usa) Products, LLC / Depuy Orthopaedics, Inc.20170—
+2K170687Flower Bone Screw SetFlower Orthopedics Corporation20170—
+2K162825CAPTIVATE™ Compression ScrewsGlobus Medical, Inc.201774—
+2K1609464.0 and 6.5 Cancellous Bone Screw and WasherSmv Scientific20161—
+2K152686Conquest FNSmith & Nephew201612—
+2K151708RECON system - Compression ScrewsNormed Medizin-Technik GmbH20160—
+2K151701Tenodesis screw systemNormed Medizin-Technik GmbH20160—
+2K152312RECON system-V-TEK-IVP Plates and ScrewsNormed Medizin-Technik GmbH201524
+2K151407RECON systemNormed Medizin-Technik GmbH20154—
+2K150871ForeFoot STP SystemTornier, Inc.20150—
+2K143039CrossRoads Screw SystemOrthodiscovery Group, LLC (D.B.A. Crossroads Extrem201579—
+2K142442Magna-FX and Mini Magna-FX Cannulated Screw Fixation SystemZimmer, Inc.2014153
+2K140741Salvation Beams and Bolts SystemWrightmedicaltechnologyinc201434—
+2K124027Monster Screw SystemApogee Orthosolutions201341—
+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—
+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—
+3K253713Arthrex Variable Angle (VA) Proximal Tibia Plating SystemArthrex, Inc.20260—
+3K252019CurvaFix Low Profile SystemCurvafix, Inc.20250—
+3K243963Pediatric Plating Platform HipOrthoPediatrics Corp.20250—
+3K241277OSSIOfiber® Threaded Trimmable Fixation NailOSSIO, Ltd.20241—
+3K233198OSSIOfiber® Threaded Trimmable Fixation NailsOSSIO, Ltd.20242—
+3K233017TM Plating SystemTyber Medical, LLC20231—
+3K230118Bony Trauma Extremity System (BTES) Screw Range, NX NailField Orthopaedics Pty, Ltd.20230—
+3K222799Haymaker® Screw SystemOrthocircle Spine D.B.A. OC Medical Devices20230—
+3K221193OSSIOfiber Compression Screw, OSSIOfiber Compression Screw, 6.5mmOSSIO, Ltd.20224—
+3K221342REDEMPTION Beaming SystemVilex, LLC20220—
+3K222409CAPTIVATE® Compression ScrewsGlobus Medical, Inc.20221—
+3K213614Cannulated ScrewsMaxxion Medical, LLC20220—
+3K220319Asnis III Cannulated Screw System, Asnis PRO Cannulated Screw SystemStryker GmbH20221—
+3K213596OSSIOfiber Compression Screw, 3.5mmOSSIO, Ltd.20214—
+3K213036Treace Medical Concepts (TMC) Screw Fixation SystemTreace Medical Concepts, Inc.20217—
+3K211783TriMed Threaded Intramedullary Nail SystemTriMed, Inc.20212—
+3K211261Axis Charcot Fixation SystemExtremity Medical, LLC20210—
+3K210247OsteoCentric Integrated Hip Fastener SystemOsteocentric Technologies D.B.A. Osteocentric Trauma20211—
+3K202657Javelin Tailor's Bunion Fixation SystemNvision Biomedical Technologies, Inc.20201—
+3K200987LTJ Screws and WasherAzurmeds, Inc.20201—
+3K201556Intraosseous Fixation SystemExtremity Medical, LLC20200—
+3K191342CrossRoads Screw SystemCrossroads Extemity Systems, LLC20190—
+3K183363Treace Medical Concepts (TMC) Snap-Off Screw SystemTreace Medical Concepts, Inc.20191—
+3K190586Monster® Screw SystemParagon 28, Inc.201921—
+3K182677DynaNail MiniMedShape, Inc.20195—
+3K180024SALVATION Midfoot NailWrightmedicaltechnologyinc20182—
+3K172698G-Beam Fusion Beaming SystemOrthofix Srl20180—
+3K171651Excelsius GPSGlobus Medical, Inc.2017691
+3K171018Axis Charcot Fixation System, 4.5 to 8.5mm Screw SystemExtremity Medical, LLC201724—
+3K150693PHIN-FX Cannulated Lag Screw SystemAscent Medical, LLC20159—
+3K152072CrossRoads Screw SystemCrossroads Extremity Systems, LLC20153—
+3K151418Monster Screw SystemParagon 28201527—
+3K143702Arthrex Blunt Tip Screws with Fiber TapeArthrex, Inc.20154—
+4K262067iFuse Granite Onyx™ Implant SystemSI-BONE, Inc.20260—
+4K260995DynaNail Helix® Fixation SystemMedShape, Inc.20260—
+4K261207Exalta Proximal Tibia Plating SystemTyber Medical, LLC20260—
+4K260291Vortex5 Tailor's Bunion Correction SystemNvision Biomedical Technologies, Inc.20260—