510(k) Report

Devices descending from K953644

438 later devices reach Volar Distal Radius Plate through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+7K182621CrossFT Knotless Deep Thread Suture Anchor with Disposable DriverConmed Corporation20190—
+7K180951Responsive Arthroscopy Suture Anchor SystemResponsive Arthroscopy, LLC20194—
+7K180554ANTHEM Fracture SystemGlobus Medical, Inc.201810—
+7K180972ARIX Clavicle SystemJeil Medical Corporation20181—
+7K171808TDM Plate and Screw SystemTdm Co., Ltd.20186—
+7K173746Activmotion RangeNewclip Technics20181—
+7K173278ToggleLoc SystemBiomet, Inc.20183—
+7K173166ANTHEM Fracture SystemGlobus Medical, Inc.201711—
+7K171725CuffLink Implant SystemConmed Corporation20170—
+7K171592CrossFT™ Knotless Biocomposite Suture Anchor with Disposable DriverConmed Corporation20171—
+7K170518In2Bones Fracture and Correction SystemIn2bones USA, LLC2017151
+7K160264Additive Orthopaedics Hammertoe Correction SystemAdditive Orthopaedics, LLC20164—
+7K160500Elite SPK, Compasso, Elite SPK KitNcs Lab Srl20160—
+7K151004PULLUP® Adjustable Juxtacortical Fixation DeviceSbm Sciences For Bio Materials20152—
+7K150768JuggerKnot Soft AnchorsBiomet Manufacturing Corp201540—
+7K151732Arthrex Fracture PlatesArthrex, Inc.201521—
+7K151068SureLock W Suture AnchorCayenne Medical, Inc.20156—
+7K151037GraftMax Button, ALB with Cradle, GraftMax Button, BTB with CradleConmed Corporation20155—
+7K143172ACL SMART SystemSmith & Nephew, Inc.20150—
+7K141263Toggleloc and Juggerloc Implants/Instruments/KitsBiomet Manufacturing Corp201402
+7K141735Arthrex Ankle Fusion Plating SystemArthrex, Inc.2014381
+7K141219Juggerloc Bone to Bone Implants/ Bone Instruments/ Bone Implant and Instrument KitsBiomet Manufacturing Corp20141—
+7K141478Arthrex Fracture Plates and ScrewsArthrex, Inc.2014231
+7K133579Multifilament Stainless Steel Sutures with CrimpsPontis Orthopaedics, LLC20140—
+7K133275Mini TightropeArthrex, Inc.201411—
+7K133224Y-Knot RC All-Suture Anchor, 2.8MM - Double Loaded and Triple Loaded W/ #2 Hifi SuturesConmed Corporation201412—
+7K130814Rigidloop Fixation Device (15MM, 60MM, XL, 20MM, 25MM, 30MM, 35MM, 40MM, 45MM, 50MM, 55MMDepuy Mitek, A Johnson & Johnson Company20133—
+7K131620Jones-FX Fracture SystemInstratek, Inc.20131—
+7K113760Variax Superior and Anterior, Lateral and Midshaft Clavicle Plates Variax Aiming Blocks…Howmedica Osteonics Corp., Dba Stryker Orthopaedics201240—
+7K111032CMC Cable FixInstratek, Inc.20112—
+7K111000Parcus 2.0MM / 2.5MM / 3.5MM Miti Titanium Suture AnchorParcus Medical, LLC20114—
+7K101616The Grapplr and Grapplr ExtenderTag Medical Corp.20111—
+7K091094Parcus V-Lox Peek CF Suture Anchor, Models: 10253, 10254, 10263, 10264Parcus Medical, LLC20097—
+7K090923Parcus Graft Fixation SystemParcus Medical, LLC200921—
+8K253065Aevumed SUPERCYNCH™ Button SystemAevumed, Inc.20260—
+8K261511Xpert AnkleNewclip Technics20260—
+8K260761APTUS Clavicle System 2.8Medartis AG20260—
+8K254182AsterOsteonic Co., Ltd.20260—
+8K252997HyperFlex® Bunion Correction SystemHyperflex Medical20250—
+8K243905Stitch Cerclage – Suture TapesGM Dos Reis Industria e Comercio Ltda.20250—
+8K251310OTS 25-L (100-5)Ots Medical, Ltd.20250—
+8K251296The Acumed Wrist Fixation SystemAcumed, LLC202501
+8K251530CONMED Argo Knotless® AnchorConmed Corporation20250—
+8K250251Eleganz Fusion Screw System (Fusion Screw System)Dev420250—
+8K250844PULLUP®; PULLUP® CLIP; BT LOOP®; PULLUP® TEX CLIP; RIGIDLOOP™ T; RIGIDLOOP™ Clip…Science & Bio Materials (S.B.M.) Sas20250—
+8K243469SignexOsteonic Co., Ltd.20250—
+8K243344Arthrex FiberTape and TigerTape Cerclage Sutures; Arthrex Radiopaque FiberTape Cerclage…Arthrex, Inc.20250—
+8K243742Arthrex DynaNite Nitinol StaplesArthrex, Inc.20250—
+8K243726Osprey Suture AnchorResponsive Arthroscopy, Inc.20250—
+8K241234OTS 25-L (100-5)Ots Medical, Ltd.20251—
+8K241128TDM Plate and Screw SystemTdm Co., Ltd.20240—
+8K242995OIC Small / Mini Fragment Plate SystemThe Orthopaedic Implant Company20240—
+8K241539Activmotion SNewclip Technics20240—
+8K234059Forma Medical Optimal Plating SystemForma Medical, Inc.20240—
+8K241235Arthrex TightRope IIArthrex, Inc.20243—
+8K240594Grappler Suture Anchor R3FLEX IOL SystemParagon 28, Inc.20241—
+8K240090Argo Knotless GENESYS AnchorConmed Corporation20242—
+8K231887ARIX Ankle Distal Tibia SystemJeil Medical Corporation20231—
+8K233429OTS 25 (100-1)Ots Medical, Ltd.20232—
+8K233258Shadow Knotless All-Suture AnchorsResponsive Arthroscopy, LLC20230—
+8K230976Arthrex Radiopaque FiberTape Cerclage suturesArthrex, Inc.20231—
+8K231236IBS-B MIS Beveled Screw SystemIn2bones USA, LLC20231—
+8K230123Apollo Knotless Suture AnchorMaruho Medical20230—
+8K223853Medartis APTUS® Ulna PlatesMedartis AG20235—
+8K220966SinefixBAAT Medical Products B.V.20231—
+8K222763Responsive Arthroscopy Mustang and Mustang Knotless Suture AnchorsResponsive Arthroscopy, LLC20221—
+8K220199AFFINITY Proximal Tibia SystemTechfit Digital Surgery, Inc.20220—
+8K213591ANTHEM® Fracture SystemGlobus Medical, Inc.20225—
+8K212381VersaTap, VersaLat, DueLock, VersaTi, MiniTiOrtho-Design (Pty), Ltd.20211—
+8K212433Anthem Fracture SystemGlobus Medical, Inc.20217—
+8K202663Suture WingOsteonic Co., Ltd.20211—
+8K203259FairFix Adjustable Button SystemMedacta International S.A.20213—
+8K203740JuggerKnot Soft AnchorRiverpoint Medical20215—
+8K203294Arthrex Pilon Fusion SystemArthrex, Inc.20212—
+8K203485SnugFit All-Suture AnchorMedacta International S.A.20212—
+8K202291Button LoopYunyi (Beijing) Medical Device Co., Ltd.20210—
+8K192709Fixone All Suture AnchorAju Pharm Co., Ltd.20203—
+8K202307Activ FuseNewclip Technics20200—
+8K202193PULLUP BTB Adjustable Fixation System for Ligament Reconstruction, PULLUP CLIP…S.B.M. Sas (Science & Bio Materials)20201—
+8K202153Responsive Arthroscopy Suture Anchor SystemResponsive Arthroscopy, LLC20201—
+8K201132Arthrex Compression ScrewsArthrex, Inc.202011—
+8K201149CoLink Plating SystemIn2bones USA, LLC20200—
+8K193461MectaLock All-Suture AnchorsMedacta International S.A.20203—
+8K193543CoLink Plating System, Fracture and Correction System, CoLink Mini Plating System…In2bones USA, LLC20200—
+8K192750AcTiFlip Naked, AcTiFlip Cinch, AcTiFlip WHIP, GFS Ultimate HipParcus Medical, LLC20203—
+8K190391TDM Plate and Screw SystemsTdm Co., Ltd.20191—
+8K191972ARIX Wrist SystemJeil Medical Corporation20190—
+8K190921Arthrex Low Profile ScrewsArthrex, Inc.20190—
+8K190953Arthrex Minimally Invasive Ankle Fusion PlateArthrex, Inc.20191—
+8K190385CoLink Plating System, Fracture and Correction System, RTS Implant System, NeoSpan…In2bones USA, LLC20190—
+8K191535CoLink® Mini Plating SystemIn2bones USA, LLC20196—
+8K190926Hammertoe Truss System (HTS)4Web, Inc.20193—
+8K190728Arthrex SwiveLock AnchorsArthrex, Inc.20192—
+8K190446Responsive Arthroscopy Wedge Push-In Suture AnchorsResponsive Arthroscopy, LLC20191—
+8K182361Arthrex Compression FT ScrewsArthrex, Inc.20184—
+8K180768Arthrex SwiveLock AnchorsArthrex, Inc.201828—
+8K182148SILVERBACK Gorilla Plating SystemParagon 28, Inc.20183—
+8K180763CuffLink Implant System BiocompositeConmed Corporation20180—
+8K180377Fracture and Correction SystemIn2bones USA, LLC20187—
+8K181067AlignX Ankle Fusion SystemExtremity Medical, LLC20184—