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
+2K111086Orthopediatrics Fracture and Osteotomy Bone Plate SystemOrthoPediatrics Corp.201171
+2K103705Low Profile ScrewsArthrex, Inc.2011219—
+2K093629Solitaire and Solitaire Peek Anterior Spinal SystemBiomet Spine20101431
+2K091798Merete Compression ScrewsMerete Medical GmbH200926—
+2K083070Toggleloc SystemBiomet Sports Medicine2008946
+2K082095Ultraslide Acromioclavicular and Syndesmotic Repair DeviceSmith & Nephew Endoscopy, Inc.200859—
+2K071639Qwix Positioning ScrewNewdeal Sas2007521
+2K061925Mini Tightrope Repair Kit, Model AR-8911DSArthrex, Inc.200633—
+2K052776Tightrope Acromioclavicular (AC) Device, Titanium, Stainless Steel , Models AR-2257…Arthrex, Inc.2005217—
+3K254280F.A.S.T ScrewSteps Ortho20260—
+3K262344Large Compression ScrewsTriMed, Inc.20260—
+3K261406Versalock Proximal Tibial Plating SystemGM Dos Reis Industria e Comercio Ltda.20261—
+3K261632Thunderbolt SystemResponsive Arthroscopy, Inc.20260—
+3K261241TriMed Compression ScrewsTriMed, Inc.20260—
+3K261145Avanti Distal Elbow ORIF SystemAvanti Orthopaedics, LLC20260—
+3K254077OSSIOfiber® Threaded Trimmable Fixation NailOSSIO, Ltd.20260—
+3K260323OrthoPediatrics® Locking Cannulated Blade Plate SystemOrthoPediatrics Corp.20260—
+3K254110DynaNail Mini; DynaNail Hybrid; DynaNail Helix; DynaClip; DynaClip Forte; DynaClip…MedShape, Inc.20261—
+3K252196Arthrex FibuLock Nail SystemArthrex, Inc.20260—
+3K251643Synchfix EVTWright Medical Technology, Inc. (Stryker Corporation)20250—
+3K252600Pediatric Plating Platform I Small-MiniOrthoPediatrics Corp.20250—
+3K251161ANTHEM® Fracture SystemGlobus Medical, Inc.20250—
+3K250867Dunamis Screw and Suture Locking SystemDunamis Medical, LLC20250—
+3K250251Eleganz Fusion Screw System (Fusion Screw System)Dev420250—
+3K243963Pediatric Plating Platform HipOrthoPediatrics Corp.20250—
+3K241599Signature Osteosynthesis Plate SystemSignature Orthopaedic Pty, Ltd.20250—
+3K243195Arthrex SS VAL and VAL KreuLock™ Compression Screw SystemArthrex, Inc.20251—
+3K233567OsteoCoil™ Nitinol Compression System (Multiple Component PNs)Flower Orthopedics Corporation Dba Conventus Flower Ortho20241—
+3K242311EXPERT - Flexible Joint Fixation SystemGM Dos Reis Industria e Comercio Ltda.20240—
+3K242554Arthrex VAL and VAL KreuLock™ Compression Screw SystemArthrex, Inc.20241—
+3K242691OsteoCentric Technologies Cannulated Fasteners and NutsOsteoCentric Technologies20240—
+3K241592Arthrex VAL and VAL KreuLock™ Compression Screw SystemArthrex, Inc.20241—
+3K240035TACTIX Vector Syndesmosis SystemVilex, LLC20241—
+3K241277OSSIOfiber® Threaded Trimmable Fixation NailOSSIO, Ltd.20241—
+3K240947TENSOR® Suture Button SystemGlobus Medical, Inc.20240—
+3K233198OSSIOfiber® Threaded Trimmable Fixation NailsOSSIO, Ltd.20242—
+3K231860TDM Screw SystemTdm Co., Ltd.20240—
+3K234040TriMed Threaded Intramedullary Nail SystemTriMed, Inc.202402
+3K232780CC-Clip® Implant SystemCc-Instruments, Inc.20230—
+3K231649Intraosseous Fusion Device SystemAuxano Medical, LLC20230—
+3K230226Integrity-SI® Fusion SystemOsteoCentric Technologies20230—
+3K230946Accelerate Compression Screw System-Small Product Code ACC-S; Accelerate Compression…Trax Surgical20230—
+3K231236IBS-B MIS Beveled Screw SystemIn2bones USA, LLC20231—
+3K231841PathLoc SI Joint Fusion SystemL&K BIOMED Co., Ltd.20231—
+3K230749TriMed Threaded Intramedullary Nail SystemTriMed, Inc.20231—
+3K230118Bony Trauma Extremity System (BTES) Screw Range, NX NailField Orthopaedics Pty, Ltd.20230—
+3K223847CREED™ Cannulated ScrewsGlw, Inc.20230—
+3K222799Haymaker® Screw SystemOrthocircle Spine D.B.A. OC Medical Devices20230—
+3K221193OSSIOfiber Compression Screw, OSSIOfiber Compression Screw, 6.5mmOSSIO, Ltd.20224—
+3K221489Artemis Proximal Femoral Nail SystemGlw, Inc.20220—
+3K221502Parcus Synd-EZ SSParcus Medical, LLC20220—
+3K220319Asnis III Cannulated Screw System, Asnis PRO Cannulated Screw SystemStryker GmbH20221—
+3K220947Arthrex Knotless AC Repair DevicesArthrex, Inc.20223—
+3K220650TriMed Ripcord DeviceTriMed, Inc.202211
+3K203773BRM TOOL ScrewsBrm Extremities Srl20221—
+3K211770R3ACT Stabilization SystemParagon 28, Inc.20213—
+3K213596OSSIOfiber Compression Screw, 3.5mmOSSIO, Ltd.20214—
+3K213644Arthrex Knotless Mini TightRopesArthrex, Inc.20211—
+3K213036Treace Medical Concepts (TMC) Screw Fixation SystemTreace Medical Concepts, Inc.20217—
+3K210016Integra DigiFuse Cannulated Intramedullary Fusion System,Integra Total Foot…Integra LifeSciences Corporation20210—
+3K211261Axis Charcot Fixation SystemExtremity Medical, LLC20210—
+3K210268LTJ Screws and WasherAzurmeds, Inc.20210—
+3K203373Advanced Research Medical Trident SI Screw SystemAdvanced Research Medical, LLC20210—
+3K203239Arthrex Low Profile ScrewsArthrex, Inc.20200—
+3K203011Monster Screw SystemParagon 28, Inc.20206—
+3K202496ANTHEM Fracture SystemGlobus Medical, Inc.20208—
+3K202259Parcus GFS II and GFS Mini, GFS Naked, GFS Ultimate, GFS BTB, ATLAS, Synd-EZ Ti…Parcus Medical, LLC20202—
+3K202817GEO Bone Screw SystemGramercy Extremity Orthopedics, LLC20201—
+3K201132Arthrex Compression ScrewsArthrex, Inc.202011—
+3K201235Arthrex MaxForce MTP Compression Plates and ScrewsArthrex, Inc.20200—
+3K201430InFrame™ Cannulated Fixation SystemExsomed Corp.20201—
+3K200398AxSOS 3 AF System and AxSOS 3 Ti SystemStryker GmbH20209—
+3K200701Skeletal Dynamics Midshaft Humerus Plating SystemSkeletal Dynamics, Inc.20200—
+3K200361Akros Scruture Anchor LisFranc Repair KitAkros Medical20200—
+3K192964Parcus Synd-EZ SSParcus Medical, LLC20191—
+3K192181PRECICE Plating SystemNuvasive Specialized Orthopedics, Inc.201921
+3K190166TriMed Nitinol Staple SystemTriMed, Inc.20190—
+3K183363Treace Medical Concepts (TMC) Snap-Off Screw SystemTreace Medical Concepts, Inc.20191—
+3K183232Double ENDOBUTTON Fixation DeviceSmith and Nephew, Inc.20196—
+3K181086Cortical Fixation SystemsCousin Biotech Sas20190—
+3K180554ANTHEM Fracture SystemGlobus Medical, Inc.201810—
+3K181600PathLoc-SI Joint Fusion SystemL&K BIOMED Co., Ltd.201811—
+3K180808Omni Foot Plating SystemExtremity Medical, LLC20183—
+3K180243Infinity-Lock Button SystemXiros, Ltd.20180—
+3K173746Activmotion RangeNewclip Technics20181—
+3K173826THP Hip Fracture Plating SystemBiomet, Inc.20180—
+3K172383Arthrosurface Bone ScrewsArthrosurface, Inc.20171—
+3K173166ANTHEM Fracture SystemGlobus Medical, Inc.201711—
+3K172213MECRON Cannulated Screw SystemMerete GmbH20170—
+3K172596Large Screws RangeNewclip Technics20174—
+3K170704The Locking Pediatric Osteotomy Plate (LolliPOP) SystemPega Medical, Inc.20170—
+3K170313ARIX Ankle Distal Tibia SystemJeil Medical Corporation20172—
+3K170518In2Bones Fracture and Correction SystemIn2bones USA, LLC2017151
+3K171018Axis Charcot Fixation System, 4.5 to 8.5mm Screw SystemExtremity Medical, LLC201724—
+3K162996INVISIKNOT Ankle Syndesmosis Repair KitSmith & Nephew, Inc.20172—
+3K170440KISSloc Suture SystemArthrosurface, Inc.20171—
+3K170012Foot and Hand MotionNewclip Technics20170—
+3K160174I.B.S. 2.0 Osteosynthesis screwIn2bones Sas201617—
+3K162307OrthoPediatrics Locking Proximal Femur System Cortical ScrewsOrthoPediatrics Corp.20161—
+3K153395OS2-C Compression StapleIn2bones Sas20167—