510(k) Report

Devices descending from K963192

581 later devices reach Synthes Sterile 3.5 MM and 4.0 MM Cannulated Screws through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+3K243963Pediatric Plating Platform HipOrthoPediatrics Corp.20250—
+3K241666EVOS Pelvic and Acetabular SystemSmith & Nephew20250—
+3K243195Arthrex SS VAL and VAL KreuLock™ Compression Screw SystemArthrex, Inc.20251—
+3K242939ARTFX Trauma Bone Plate and Screw SystemArtfx Medical20242—
+3K233567OsteoCoil™ Nitinol Compression System (Multiple Component PNs)Flower Orthopedics Corporation Dba Conventus Flower Ortho20241—
+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—
+3K241277OSSIOfiber® Threaded Trimmable Fixation NailOSSIO, Ltd.20241—
+3K233008Cannulated Headless Bone ScrewsAap Implantate AG20240—
+3K233198OSSIOfiber® Threaded Trimmable Fixation NailsOSSIO, Ltd.20242—
+3K231860TDM Screw SystemTdm Co., Ltd.20240—
+3K234040TriMed Threaded Intramedullary Nail SystemTriMed, Inc.202402
+3K231649Intraosseous Fusion Device SystemAuxano Medical, LLC20230—
+3K230226Integrity-SI® Fusion SystemOsteoCentric Technologies20230—
+3K230946Accelerate Compression Screw System-Small Product Code ACC-S; Accelerate Compression…Trax Surgical20230—
+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—
+3K221193OSSIOfiber Compression Screw, OSSIOfiber Compression Screw, 6.5mmOSSIO, Ltd.20224—
+3K210935I.T.S. Pelvic Reconstruction System (PRS RX & PRS Phoenix)I.T.S. GmbH202231
+3K220319Asnis III Cannulated Screw System, Asnis PRO Cannulated Screw SystemStryker GmbH20221—
+3K220181StealthFix Intraosseous Fixation SystemNextremity Solutions, Inc.20221—
+3K203773BRM TOOL ScrewsBrm Extremities Srl20221—
+3K213596OSSIOfiber Compression Screw, 3.5mmOSSIO, Ltd.20214—
+3K203373Advanced Research Medical Trident SI Screw SystemAdvanced Research Medical, LLC20210—
+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—
+3K192181PRECICE Plating SystemNuvasive Specialized Orthopedics, Inc.201921
+3K183232Double ENDOBUTTON Fixation DeviceSmith and Nephew, Inc.20196—
+3K181600PathLoc-SI Joint Fusion SystemL&K BIOMED Co., Ltd.201811—
+3K181113CoLink™ Afx Plating SystemIn2bones USA, LLC201814—
+3K180808Omni Foot Plating SystemExtremity Medical, LLC20183—
+3K172383Arthrosurface Bone ScrewsArthrosurface, Inc.20171—
+3K170704The Locking Pediatric Osteotomy Plate (LolliPOP) SystemPega Medical, Inc.20170—
+3K170313ARIX Ankle Distal Tibia SystemJeil Medical Corporation20172—
+3K171448Hammertoe Correction SystemLife Spine, Inc.20170—
+3K1626852-Piece Hammertoe Correction SystemLife Spine, Inc.20170—
+3K162307OrthoPediatrics Locking Proximal Femur System Cortical ScrewsOrthoPediatrics Corp.20161—
+3K160058Biomet Variable Pitch Compression Screw SystemBiomet, Inc.20160—
+3K153333Epic Extremity Cannulated Screw SystemEpic Extremity, LLC20161—
+3K150889Suture Wires and Wire LoopsZimmer, Inc.20152—
+3K150626Rush Medullary PinsZimmer, Inc.20150—
+3K143702Arthrex Blunt Tip Screws with Fiber TapeArthrex, Inc.20154—
+3K143614Arthrex Low Profile ScrewsArthrex, Inc.201519—
+3K141478Arthrex Fracture Plates and ScrewsArthrex, Inc.2014231
+3K133662Smith & Nephew Cannulated Captured ScrewSmith & Nephew, Inc.20148—
+3K140397Paralock Plating System / Tuffnek ScrewParagon 28201431—
+3K132911I.B.S Snap-Off Screw / Solafix Snap-Off ScrewIn2bones Sas20140—
+3K132217Arthrex Compression FT ScrewsArthrex, Inc.201318—
+3K131186Synthes 2.7MM and 3.5MM Variable Angle LCP Midfoot/Hindfoot SystemSynthes (USA) Products, LLC20138—
+3K131061Restore Bunion Correction SystemNextremity Solutions201315—
+3K131722I.T.S. Extremity Fixation SystemsI.T.S. GmbH2013242
+3K131474Arthrex Distal Radius Plate SystemArthrex, Inc.201320—
+3K123241Arthrex Fracture PlatesArthrex, Inc.201371—
+3K123890Acumed Cannulated Screw SystemAcumed, LLC2013362
+3K122538Acumed Pelvic Bone Plate SystemAcumed, LLC201241
+3K111678Ortho Solutions Extremity Fixation Implants for OsteosysnthesisOrtho Solutions Limited2012581
+3K112437Arthrex Fracture SystemArthrex, Inc.201191—
+3K111253Arthrex Distal Extremity Plate SystemArthrex, Inc.2011135—
+3K100359Darco Headed Cannulated ScrewWrightmedicaltechnologyinc2010145—
+3K081813Universal Compression Fracture Repair SystemU.S. Implant Solutions, LLC20094—
+3K082874Biodrive Cannulated Screw SystemBiomet Trauma2009168—
+4K262618Arthrex Spine Compression FT ScrewArthrex, Inc.20260—
+4K261830FRAXION 3.5 Plate System (Various - See Catalog);FRAXION 4.5 Plate System (Various - See…Ortler Global Tibbi Gerecler Anonim Sirketi20260—
+4K260106OsteoCoil™ GT Active Compression SystemFlower Orthopedics Corporation DBA Conventus Flower Orthoped20260—
+4K261406Versalock Proximal Tibial Plating SystemGM Dos Reis Industria e Comercio Ltda.20261—
+4K260809Arthrex Sterile VAL and VAL KreuLock™ Compression Screw SystemArthrex, Inc.20260—
+4K261154CoLink® & CoLag® Non-Sterile ScrewsIn2Bones USA, LLC20260—
+4K254215Arthrex Beaming SystemArthrex, Inc.20261—
+4K260390Super Upper Limbs Versalock Plating SystemGM Dos Reis Industria e Comercio Ltda.20261—
+4K260361Treace Medical Concepts (TMC) Screw Fixation SystemTreace Medical Concepts, Inc.20260—
+4K253713Arthrex Variable Angle (VA) Proximal Tibia Plating SystemArthrex, Inc.20260—
+4K252807Arthrex Anatomic Lapidus Plates and I-Beam Lapidus PlatesArthrex, Inc.20260—
+4K250867Dunamis Screw and Suture Locking SystemDunamis Medical, LLC20250—
+4K243368Montblanc Plate SystemMedifield Medical Co., Ltd.20250—
+4K243740Versalock Upper Limb Plating SystemGM Dos Reis Industria e Comercio Ltda.20251—
+4K242998GMReis Ankle Plating SystemGM Dos Reis Industria e Comercio Ltda.20241—
+4K242415TMC Compression Implant SystemTreace Medical Concepts20243—
+4K230546SignexOsteonic Co., Ltd.20242—
+4K233665DePuy Synthes VOLT Mini Fragment Plating System, DePuy Synthes VOLT Small Fragment…DePuy Synthes20244—
+4K233912ARIX Cannulated Screw SystemJeil Medical Corporation20240—
+4K240212COGNiTiON™ Staple SystemOrtho Solutions UK, Ltd.20240—
+4K240201PathLoc SI Joint Fusion SystemL&K BIOMED Co., Ltd.20240—
+4K232324StealthFix Intraosseous Fixation SystemMedartis, Inc.20230—
+4K223150APS Metal Plate & Screw SystemA Plus Biotechnology Co., Ltd.20230—
+4K222665Medline UNITE® Ankle Fusion Plating SystemMedline Industries, Inc.20230—
+4K221333Acumed Acutrak System- MR Conditional, Acumed Acturak 2 System- MR ConditionalAcumed, LLC202204
+4K222820BRM TOOL Screws, BIOPLAN Subtalar ImplantBrm Extremities20220—
+4K222267Arthrex 2.4 mm Volar Distal Radius Plate SystemArthrex, Inc.20221—
+4K222244Arthrex 3.5 mm Locking Compression PlatesArthrex, Inc.20221—
+4K213126Smith & Nephew, Inc. Plates and Screws Systems: EVOS, Peri-Loc, D-Rad, TC-100, VLP…Smith & Nephew, Inc.202221
+4K220839Arthrex Compression FT PinsArthrex, Inc.20220—
+4K221485Arthrex FiberTape and TigerTape Cerclage SuturesArthrex, Inc.20225—
+4K213837Arthrx Fracture PlatesArthrex, Inc.20220—
+4K220892ExsoMed INnate NanoTM Lag Screw SystemExsomed Corp.20220—
+4K213069CoLink NeoFuse Plating SystemIn2bones USA, LLC20211—
+4K212487CoLink Vallux Plating SystemIn2bones USA, LLC20214—