510(k) Report

Devices descending from K963172

722 later devices reach Synthes Sterile 4.5 MM Cannulated Screws through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K170038FuzeFix Screw SystemFusion Orthopedics, LLC20171—
+1K170021SMV Scientific Cannulated ScrewsSmv Scientific20178—
+1K163303OsteoMed ExtremiFix Mid and Large Screw SystemOsteomed, LLC20173—
+1K161616DePuy Synthes 4.0 mm and 4.5 mm Cortex Screws, DePuy Synthes 2.4 mm Cannulated Screws…Synthes USA Products, LLC201733—
+1K153338Tiger Cannulated Screw SystemTrilliant Surgical, Ltd.201674
+1K150693PHIN-FX Cannulated Lag Screw SystemAscent Medical, LLC20159—
+1K142057Infix Cannulated Screw SystemInfix Medical, LLC20151—
+1K140891Biomet Cannulated Screw SystemBiomet, Inc.2014165
+1K133668Aft Greater Tuberosity Fracture Plate, Left, Aft Greater Tuberosity Fracture Plate…Shoulder Options, Inc.201416—
+1K124027Monster Screw SystemApogee Orthosolutions201341—
+1K121672Aft Proximal Humerus Fracture PlateShoulder Options, Inc.201220—
+1K112240Dyna Locking Cannulated ScrewU&I Corp.201214—
+1K110895Ortho Solutions Trauma Implants for OsteosynthesisOrtho Solutions Limited20118—
+1K102343Emerge Medical Cannulated Screw Fixation SystemEmerge Medical2010220—
+1K093676Omnitech Large, Trimed Compression ScrewTriMed, Inc.201013—
+1K081813Universal Compression Fracture Repair SystemU.S. Implant Solutions, LLC20094—
+1K082874Biodrive Cannulated Screw SystemBiomet Trauma2009168—
+1K082949Orthopediatrics Bone ScrewsOrthoPediatrics Corp.200811—
+1K050346Stabilization ScrewNew Deal, S.A.2005554
+1K043248Tightrope Syndesmosis Repair Kit, Titanium, Model AR-8920DS; Stainless Steel. Model…Arthrex, Inc.2005306—
+2K260995DynaNail Helix® Fixation SystemMedShape, Inc.20260—
+2K260277Mikron Trauma Bone Plate& Screw SystemMikron Makina San. ve Tic. Ltd. Sti.20260—
+2K252699CoAptix S SystemUniversity of Utah, Department of Orthopaedics20260—
+2K252081SportLinc Syndesmosis DeviceLincotek Medical20260—
+2K253488iFuse INTRA Ti™ Implant SystemSI-BONE, Inc.20260—
+2K253727Syndesmosis TightRope PROArthrex, Inc.20250—
+2K242988Genostis Osteosynthesis SystemGenostis AF20250—
+2K243943TriMed® Compression ScrewsTriMed, Inc.20252—
+2K241504iFuse TORQ TNT™ Implant SystemSI-BONE, Inc.20240—
+2K232941Megaloop Button SystemSuzhou Endophix Co., Ltd.20240—
+2K231272OSSIOfiber® Pin Product Family, OSSIOfiber® Compression Screw, OSSIOfiber® Trimmable…OSSIO, Ltd.20233—
+2K223933Exactech Equinoxe PHx Fracture System; Exactech EPIC ScrewsExactech, Inc.20230—
+2K230867Bone Bolt SystemUniversity of Utah, Department of Orthopaedics20230—
+2K230744Acumed Acutrak 3 Headless Compression Screw SystemAcumed, LLC20231—
+2K221090Metal Cannulated ScrewDouble Medical Technology, Inc.20230—
+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—
+2K222409CAPTIVATE® Compression ScrewsGlobus Medical, Inc.20221—
+2K212979CalcShift™ Displacement Calcaneal Osteotomy SystemNextremity Solutions, Inc.20220—
+2K220260Hercules Syndesmosis Implant SystemIn2bones USA, LLC20220—
+2K212755SIGNUS SACRONAIL® Transsacral Stabilization SystemSignus Medizintechnik GmbH20220—
+2K212378Arsenal Ankle Plating SystemTrilliant Surgical20220—
+2K213199Asnis® III Cannulated Screw System and Asnis® PRO Cannulated Screw SystemStryker GmbH20222—
+2K212990Acumed Ankle Syndesmosis Repair SystemAcumed, LLC20220—
+2K203595DynaFuse Fixation SystemMedShape, Inc.20225—
+2K213301InCore Subtalar SystemNextremity Solutions, Inc.20210—
+2K211435PAO Cortical ScrewMedacta International S.A.20210—
+2K211783TriMed Threaded Intramedullary Nail SystemTriMed, Inc.20212—
+2K211290Cannulated Fasteners and NutsOsteoCentric Technologies20212—
+2K210159IntraLock SystemFusion Orthopedics, LLC20210—
+2K203121Responsive Arthroscopy Thunderbolt SystemResponsive Arthroscopy, LLC20211—
+2K210754Cannulated Fasteners and NutsOsteoCentric Technologies20213—
+2K200291CREED™ Cannulated ScrewsGlw Medical, Inc.20202—
+2K193214WasherLoc and No-Profile Screw and Washer Systems, Biomet Cannulated Screw System…Biomet, Inc.20203—
+2K200332EXPERT - Joint Fixation SystemGM Dos Reis Industria e Comercio Ltda.20201—
+2K200987LTJ Screws and WasherAzurmeds, Inc.20201—
+2K201522Arthrex Syndesmosis TightRope XP Buttress Plate Implant SystemArthrex, Inc.20207—
+2K193660OSSIOfiber™ Compression ScrewsOSSIO, Ltd.20206—
+2K201556Intraosseous Fixation SystemExtremity Medical, LLC20200—
+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—
+2K191783Parcus Synd-EZ TiParcus Medical, LLC20195—
+2K190830TDM Screw SystemsTdm Co., Ltd.20191—
+2K191319Dunamis Fixation Button SystemDunamis, LLC20191—
+2K190586Monster® Screw SystemParagon 28, Inc.201921—
+2K173910Impress SFS SystemCable Fix Medical, LLC20180—
+2K171320ARMAR / ARTIS Small Fragment and Calcaneal Plates & MBOSS / FIXION Screws, ARMAR/ ARTIS…Meril Healthcare Pvt., Ltd.20182—
+2K171703PUMA SystemPanther Orthopedics, Inc.20180—
+2K173550Akros FibuLink™ Syndesmosis Repair KitAkros Medical20174—
+2K172620SyndesMetrics Syndesmosis Repair SystemMortise Medical, LLC20170—
+2K172617Treace Medical Concepts (TMC) Compression Screw SystemTreace Medical Concepts, Inc.201711—
+2K170249GRAVITY™ Syndesmosis LPWrightmedicaltechnologyinc20172—
+2K160553DePuy Synthes 4.0 mm and 5.0 mm Locking Screws – MR Conditional, DePuy Synthes Wrist…Synthes (Usa) Products, LLC / Depuy Orthopaedics, Inc.20170—
+2K162874Cannulated Screws NeoorthoNeoortho Produtos Ortopedicos S/A20170—
+2K170594I.B.S. osteosynthesis screwsIn2bones Sas20171—
+2K163361ANTHEM™ Fracture SystemGlobus Medical, Inc.201714—
+2K163489OrthoSolutions 'System26' Bone ScrewsOrtho Solutions UK Limited201731
+2K161904GEO Bone Screw SystemGramercy Extremity Orthopeidics, LLC20174—
+2K162805Akros Fibulink Syndesmosis Repair KitAkros Medical20175—
+2K153656PathLoc-SI Joint Fusion SystemL&K BIOMED Co., Ltd.201613—
+2K160617Large Screws RangeNewclip Technics20166—
+2K151418Monster Screw SystemParagon 28201527—
+2K150889Suture Wires and Wire LoopsZimmer, Inc.20152—
+2K150359Tensyn PlugDallen Medical, Inc.20150—
+2K150626Rush Medullary PinsZimmer, Inc.20150—
+2K1431883.Omm Biomet Cannulated Screw SystemBiomet Manufacturing Corp201481
+2K140431Pediloc Fragment SystemOrthoPediatrics Corp.20141—
+2K131920Stabilization ScrewIn2bones Sas2014183
+2K140018TSP Hip Fracture Plating SystemBiomet, Inc.201412
+2K133858Tensyn BandDallen Medical, Inc.20143—
+2K132733Orthohelix Syndesmosis Fixation DevicesOrthohelix Surgical Designs, Inc.20143—
+2K131850Tensyn BandDallen Medical, Inc.20135—
+2K130954Ars Screw; Slant ScrewAdvanced Interventional Technology, LLC20130—
+2K112794Eos Small Bone Fixation SystemTriMed, Inc.201294
+2K111971Synde-Lock Syndesmosis Repair KitTarsus Medical, Inc.20120—
+2K112437Arthrex Fracture SystemArthrex, Inc.201191—
+2K110959Orthopediatrics Blade Plate SystemOrthoPediatrics Corp.201123