510(k) Report

Devices descending from K043248

306 later devices reach Tightrope Syndesmosis Repair Kit, Titanium, Model AR-8920DS; Stainless Steel.… through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+3K200028Coronet Soft Tissue Fixation SystemConextions Medical20202—
+3K193165MectaFix CL Fixation Button with Continuous LoopMedacta International S.A.20200—
+3K192984APTUS Clavicle SystemMedartis AG20206—
+3K191426FiberTak ButtonArthrex, Inc.20190—
+3K190143LARS AC Band DeviceCorin USA20191—
+3K190288Arthrex Tenodesis ButtonArthrex, Inc.20194—
+3K190774RIGIDLOOP Titanium Button , RIGIDLOOP Cortical Fixation System XL ImplantMedos International SARL20191—
+3K191204Infinity Fixation SystemConmed Corporation20190—
+3K183094CyclaPlex Correction SystemCycla Orthopedics, Ltd.20190—
+3K180554ANTHEM Fracture SystemGlobus Medical, Inc.201810—
+3K180972ARIX Clavicle SystemJeil Medical Corporation20181—
+3K171808TDM Plate and Screw SystemTdm Co., Ltd.20186—
+3K173746Activmotion RangeNewclip Technics20181—
+3K173278ToggleLoc SystemBiomet, Inc.20183—
+3K173166ANTHEM Fracture SystemGlobus Medical, Inc.201711—
+3K170518In2Bones Fracture and Correction SystemIn2bones USA, LLC2017151
+3K160264Additive Orthopaedics Hammertoe Correction SystemAdditive Orthopaedics, LLC20164—
+3K151004PULLUP® Adjustable Juxtacortical Fixation DeviceSbm Sciences For Bio Materials20152—
+3K150768JuggerKnot Soft AnchorsBiomet Manufacturing Corp201540—
+3K151732Arthrex Fracture PlatesArthrex, Inc.201521—
+3K151037GraftMax Button, ALB with Cradle, GraftMax Button, BTB with CradleConmed Corporation20155—
+3K143172ACL SMART SystemSmith & Nephew, Inc.20150—
+3K141263Toggleloc and Juggerloc Implants/Instruments/KitsBiomet Manufacturing Corp201402
+3K141735Arthrex Ankle Fusion Plating SystemArthrex, Inc.2014381
+3K141219Juggerloc Bone to Bone Implants/ Bone Instruments/ Bone Implant and Instrument KitsBiomet Manufacturing Corp20141—
+3K141478Arthrex Fracture Plates and ScrewsArthrex, Inc.2014231
+3K133579Multifilament Stainless Steel Sutures with CrimpsPontis Orthopaedics, LLC20140—
+3K133275Mini TightropeArthrex, Inc.201411—
+3K130814Rigidloop Fixation Device (15MM, 60MM, XL, 20MM, 25MM, 30MM, 35MM, 40MM, 45MM, 50MM, 55MMDepuy Mitek, A Johnson & Johnson Company20133—
+3K131620Jones-FX Fracture SystemInstratek, Inc.20131—
+3K113760Variax Superior and Anterior, Lateral and Midshaft Clavicle Plates Variax Aiming Blocks…Howmedica Osteonics Corp., Dba Stryker Orthopaedics201240—
+3K111032CMC Cable FixInstratek, Inc.20112—
+3K101616The Grapplr and Grapplr ExtenderTag Medical Corp.20111—
+3K090923Parcus Graft Fixation SystemParcus Medical, LLC200921—
+4K253065Aevumed SUPERCYNCH™ Button SystemAevumed, Inc.20260—
+4K261511Xpert AnkleNewclip Technics20260—
+4K260761APTUS Clavicle System 2.8Medartis AG20260—
+4K254182AsterOsteonic Co., Ltd.20260—
+4K252997HyperFlex® Bunion Correction SystemHyperflex Medical20250—
+4K243905Stitch Cerclage – Suture TapesGM Dos Reis Industria e Comercio Ltda.20250—
+4K250251Eleganz Fusion Screw System (Fusion Screw System)Dev420250—
+4K250844PULLUP®; PULLUP® CLIP; BT LOOP®; PULLUP® TEX CLIP; RIGIDLOOP™ T; RIGIDLOOP™ Clip…Science & Bio Materials (S.B.M.) Sas20250—
+4K243469SignexOsteonic Co., Ltd.20250—
+4K243344Arthrex FiberTape and TigerTape Cerclage Sutures; Arthrex Radiopaque FiberTape Cerclage…Arthrex, Inc.20250—
+4K243742Arthrex DynaNite Nitinol StaplesArthrex, Inc.20250—
+4K242939ARTFX Trauma Bone Plate and Screw SystemArtfx Medical20242—
+4K241128TDM Plate and Screw SystemTdm Co., Ltd.20240—
+4K242995OIC Small / Mini Fragment Plate SystemThe Orthopaedic Implant Company20240—
+4K241539Activmotion SNewclip Technics20240—
+4K234059Forma Medical Optimal Plating SystemForma Medical, Inc.20240—
+4K241235Arthrex TightRope IIArthrex, Inc.20243—
+4K240594Grappler Suture Anchor R3FLEX IOL SystemParagon 28, Inc.20241—
+4K231887ARIX Ankle Distal Tibia SystemJeil Medical Corporation20231—
+4K230976Arthrex Radiopaque FiberTape Cerclage suturesArthrex, Inc.20231—
+4K231236IBS-B MIS Beveled Screw SystemIn2bones USA, LLC20231—
+4K223853Medartis APTUS® Ulna PlatesMedartis AG20235—
+4K220966SinefixBAAT Medical Products B.V.20231—
+4K220199AFFINITY Proximal Tibia SystemTechfit Digital Surgery, Inc.20220—
+4K213591ANTHEM® Fracture SystemGlobus Medical, Inc.20225—
+4K212433Anthem Fracture SystemGlobus Medical, Inc.20217—
+4K203259FairFix Adjustable Button SystemMedacta International S.A.20213—
+4K203740JuggerKnot Soft AnchorRiverpoint Medical20215—
+4K203294Arthrex Pilon Fusion SystemArthrex, Inc.20212—
+4K203485SnugFit All-Suture AnchorMedacta International S.A.20212—
+4K202291Button LoopYunyi (Beijing) Medical Device Co., Ltd.20210—
+4K202307Activ FuseNewclip Technics20200—
+4K202193PULLUP BTB Adjustable Fixation System for Ligament Reconstruction, PULLUP CLIP…S.B.M. Sas (Science & Bio Materials)20201—
+4K201132Arthrex Compression ScrewsArthrex, Inc.202011—
+4K201149CoLink Plating SystemIn2bones USA, LLC20200—
+4K193461MectaLock All-Suture AnchorsMedacta International S.A.20203—
+4K193543CoLink Plating System, Fracture and Correction System, CoLink Mini Plating System…In2bones USA, LLC20200—
+4K192750AcTiFlip Naked, AcTiFlip Cinch, AcTiFlip WHIP, GFS Ultimate HipParcus Medical, LLC20203—
+4K190391TDM Plate and Screw SystemsTdm Co., Ltd.20191—
+4K191972ARIX Wrist SystemJeil Medical Corporation20190—
+4K190921Arthrex Low Profile ScrewsArthrex, Inc.20190—
+4K190953Arthrex Minimally Invasive Ankle Fusion PlateArthrex, Inc.20191—
+4K190385CoLink Plating System, Fracture and Correction System, RTS Implant System, NeoSpan…In2bones USA, LLC20190—
+4K191535CoLink® Mini Plating SystemIn2bones USA, LLC20196—
+4K190926Hammertoe Truss System (HTS)4Web, Inc.20193—
+4K190728Arthrex SwiveLock AnchorsArthrex, Inc.20192—
+4K182361Arthrex Compression FT ScrewsArthrex, Inc.20184—
+4K180768Arthrex SwiveLock AnchorsArthrex, Inc.201828—
+4K182148SILVERBACK Gorilla Plating SystemParagon 28, Inc.20183—
+4K180377Fracture and Correction SystemIn2bones USA, LLC20187—
+4K181067AlignX Ankle Fusion SystemExtremity Medical, LLC20184—
+4K173121Ankle Fusion Plating SystemIn2bones Sas20172—
+4K162198GFS UltimateParcus Medical, LLC20168—
+4K153558Ventix Suture AnchorBiomet Manufacturing Corp20160—
+4K142653G-Lok and G-Lok XL ExtenderT.A.G. Medical Products Corporation, Ltd.20140—
+4K140259Variax Clavicle Hook PlateStryker Trauma AG201413—
+4K140328CMC Mini TightropeArthrex, Inc.20146—
+4K133757GFS II Standard, GFS II Large, GFS MimiParcus Medical, LLC201416—
+4K132502Variax 2 SystemStryker Trauma AG201321—
+4K130116Superior Lateral Variax Clavicle PlateStryker Trauma AG201316—
+5K254280F.A.S.T ScrewSteps Ortho20260—
+5K261830FRAXION 3.5 Plate System (Various - See Catalog);FRAXION 4.5 Plate System (Various - See…Ortler Global Tibbi Gerecler Anonim Sirketi20260—
+5K260277Mikron Trauma Bone Plate& Screw SystemMikron Makina San. ve Tic. Ltd. Sti.20260—
+5K260809Arthrex Sterile VAL and VAL KreuLock™ Compression Screw SystemArthrex, Inc.20260—
+5K261154CoLink® & CoLag® Non-Sterile ScrewsIn2Bones USA, LLC20260—
+5K254215Arthrex Beaming SystemArthrex, Inc.20261—