510(k) Report

Devices descending from K974876

419 later devices reach Bionx Distal Radius Screw through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+6K141478Arthrex Fracture Plates and ScrewsArthrex, Inc.2014231
+6K133579Multifilament Stainless Steel Sutures with CrimpsPontis Orthopaedics, LLC20140—
+6K133275Mini TightropeArthrex, Inc.201411—
+6K133224Y-Knot RC All-Suture Anchor, 2.8MM - Double Loaded and Triple Loaded W/ #2 Hifi SuturesConmed Corporation201412—
+6K130814Rigidloop Fixation Device (15MM, 60MM, XL, 20MM, 25MM, 30MM, 35MM, 40MM, 45MM, 50MM, 55MMDepuy Mitek, A Johnson & Johnson Company20133—
+6K131620Jones-FX Fracture SystemInstratek, Inc.20131—
+6K113760Variax Superior and Anterior, Lateral and Midshaft Clavicle Plates Variax Aiming Blocks…Howmedica Osteonics Corp., Dba Stryker Orthopaedics201240—
+6K111032CMC Cable FixInstratek, Inc.20112—
+6K111000Parcus 2.0MM / 2.5MM / 3.5MM Miti Titanium Suture AnchorParcus Medical, LLC20114—
+6K101616The Grapplr and Grapplr ExtenderTag Medical Corp.20111—
+6K091094Parcus V-Lox Peek CF Suture Anchor, Models: 10253, 10254, 10263, 10264Parcus Medical, LLC20097—
+6K090923Parcus Graft Fixation SystemParcus Medical, LLC200921—
+7K253065Aevumed SUPERCYNCH™ Button SystemAevumed, Inc.20260—
+7K261511Xpert AnkleNewclip Technics20260—
+7K260761APTUS Clavicle System 2.8Medartis AG20260—
+7K254182AsterOsteonic Co., Ltd.20260—
+7K252997HyperFlex® Bunion Correction SystemHyperflex Medical20250—
+7K243905Stitch Cerclage – Suture TapesGM Dos Reis Industria e Comercio Ltda.20250—
+7K251310OTS 25-L (100-5)Ots Medical, Ltd.20250—
+7K251296The Acumed Wrist Fixation SystemAcumed, LLC202501
+7K251530CONMED Argo Knotless® AnchorConmed Corporation20250—
+7K250251Eleganz Fusion Screw System (Fusion Screw System)Dev420250—
+7K250844PULLUP®; PULLUP® CLIP; BT LOOP®; PULLUP® TEX CLIP; RIGIDLOOP™ T; RIGIDLOOP™ Clip…Science & Bio Materials (S.B.M.) Sas20250—
+7K243469SignexOsteonic Co., Ltd.20250—
+7K243344Arthrex FiberTape and TigerTape Cerclage Sutures; Arthrex Radiopaque FiberTape Cerclage…Arthrex, Inc.20250—
+7K243742Arthrex DynaNite Nitinol StaplesArthrex, Inc.20250—
+7K243726Osprey Suture AnchorResponsive Arthroscopy, Inc.20250—
+7K241234OTS 25-L (100-5)Ots Medical, Ltd.20251—
+7K242939ARTFX Trauma Bone Plate and Screw SystemArtfx Medical20242—
+7K241128TDM Plate and Screw SystemTdm Co., Ltd.20240—
+7K242995OIC Small / Mini Fragment Plate SystemThe Orthopaedic Implant Company20240—
+7K241539Activmotion SNewclip Technics20240—
+7K234059Forma Medical Optimal Plating SystemForma Medical, Inc.20240—
+7K241235Arthrex TightRope IIArthrex, Inc.20243—
+7K240594Grappler Suture Anchor R3FLEX IOL SystemParagon 28, Inc.20241—
+7K240090Argo Knotless GENESYS AnchorConmed Corporation20242—
+7K231887ARIX Ankle Distal Tibia SystemJeil Medical Corporation20231—
+7K233429OTS 25 (100-1)Ots Medical, Ltd.20232—
+7K233258Shadow Knotless All-Suture AnchorsResponsive Arthroscopy, LLC20230—
+7K230976Arthrex Radiopaque FiberTape Cerclage suturesArthrex, Inc.20231—
+7K231236IBS-B MIS Beveled Screw SystemIn2bones USA, LLC20231—
+7K230123Apollo Knotless Suture AnchorMaruho Medical20230—
+7K223853Medartis APTUS® Ulna PlatesMedartis AG20235—
+7K220966SinefixBAAT Medical Products B.V.20231—
+7K222763Responsive Arthroscopy Mustang and Mustang Knotless Suture AnchorsResponsive Arthroscopy, LLC20221—
+7K220199AFFINITY Proximal Tibia SystemTechfit Digital Surgery, Inc.20220—
+7K213591ANTHEM® Fracture SystemGlobus Medical, Inc.20225—
+7K212381VersaTap, VersaLat, DueLock, VersaTi, MiniTiOrtho-Design (Pty), Ltd.20211—
+7K212433Anthem Fracture SystemGlobus Medical, Inc.20217—
+7K202663Suture WingOsteonic Co., Ltd.20211—
+7K203259FairFix Adjustable Button SystemMedacta International S.A.20213—
+7K203740JuggerKnot Soft AnchorRiverpoint Medical20215—
+7K203294Arthrex Pilon Fusion SystemArthrex, Inc.20212—
+7K203485SnugFit All-Suture AnchorMedacta International S.A.20212—
+7K202291Button LoopYunyi (Beijing) Medical Device Co., Ltd.20210—
+7K192709Fixone All Suture AnchorAju Pharm Co., Ltd.20203—
+7K202307Activ FuseNewclip Technics20200—
+7K202193PULLUP BTB Adjustable Fixation System for Ligament Reconstruction, PULLUP CLIP…S.B.M. Sas (Science & Bio Materials)20201—
+7K202153Responsive Arthroscopy Suture Anchor SystemResponsive Arthroscopy, LLC20201—
+7K201132Arthrex Compression ScrewsArthrex, Inc.202011—
+7K201149CoLink Plating SystemIn2bones USA, LLC20200—
+7K193461MectaLock All-Suture AnchorsMedacta International S.A.20203—
+7K193543CoLink Plating System, Fracture and Correction System, CoLink Mini Plating System…In2bones USA, LLC20200—
+7K192750AcTiFlip Naked, AcTiFlip Cinch, AcTiFlip WHIP, GFS Ultimate HipParcus Medical, LLC20203—
+7K190391TDM Plate and Screw SystemsTdm Co., Ltd.20191—
+7K191972ARIX Wrist SystemJeil Medical Corporation20190—
+7K190921Arthrex Low Profile ScrewsArthrex, Inc.20190—
+7K190953Arthrex Minimally Invasive Ankle Fusion PlateArthrex, Inc.20191—
+7K190385CoLink Plating System, Fracture and Correction System, RTS Implant System, NeoSpan…In2bones USA, LLC20190—
+7K191535CoLink® Mini Plating SystemIn2bones USA, LLC20196—
+7K190926Hammertoe Truss System (HTS)4Web, Inc.20193—
+7K190728Arthrex SwiveLock AnchorsArthrex, Inc.20192—
+7K190446Responsive Arthroscopy Wedge Push-In Suture AnchorsResponsive Arthroscopy, LLC20191—
+7K182361Arthrex Compression FT ScrewsArthrex, Inc.20184—
+7K180768Arthrex SwiveLock AnchorsArthrex, Inc.201828—
+7K182148SILVERBACK Gorilla Plating SystemParagon 28, Inc.20183—
+7K180763CuffLink Implant System BiocompositeConmed Corporation20180—
+7K180377Fracture and Correction SystemIn2bones USA, LLC20187—
+7K181067AlignX Ankle Fusion SystemExtremity Medical, LLC20184—
+7K173121Ankle Fusion Plating SystemIn2bones Sas20172—
+7K172186BioWick X Implant with DriverCayenne Medical, Inc.20174—
+7K171465Stryker Self-Punching ICONIXStryker20171—
+7K162198GFS UltimateParcus Medical, LLC20168—
+7K153558Ventix Suture AnchorBiomet Manufacturing Corp20160—
+7K142653G-Lok and G-Lok XL ExtenderT.A.G. Medical Products Corporation, Ltd.20140—
+7K140259Variax Clavicle Hook PlateStryker Trauma AG201413—
+7K140328CMC Mini TightropeArthrex, Inc.20146—
+7K133757GFS II Standard, GFS II Large, GFS MimiParcus Medical, LLC201416—
+7K132502Variax 2 SystemStryker Trauma AG201321—
+7K130116Superior Lateral Variax Clavicle PlateStryker Trauma AG201316—
+7K102326Parcus 3.5MM Peek CF Push-in Suture AnchorParcus Medical, LLC20105—
+7K102162Parcus Peek CF Push-in Suture AnchorParcus Medical, LLC20100—
+8K254280F.A.S.T ScrewSteps Ortho20260—
+8K261830FRAXION 3.5 Plate System (Various - See Catalog);FRAXION 4.5 Plate System (Various - See…Ortler Global Tibbi Gerecler Anonim Sirketi20260—
+8K260277Mikron Trauma Bone Plate& Screw SystemMikron Makina San. ve Tic. Ltd. Sti.20260—
+8K260809Arthrex Sterile VAL and VAL KreuLock™ Compression Screw SystemArthrex, Inc.20260—
+8K261154CoLink® & CoLag® Non-Sterile ScrewsIn2Bones USA, LLC20260—
+8K254215Arthrex Beaming SystemArthrex, Inc.20261—
+8K252246Leforte MMF SystemJeil Medical Corporation20260—
+8K253886Grappler Suture Anchor PCFD Tether SystemParagon 28, Inc.20260—