510(k) Report

Devices descending from K953644

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

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+6K223847CREED™ Cannulated ScrewsGlw, Inc.20230—
+6K221193OSSIOfiber Compression Screw, OSSIOfiber Compression Screw, 6.5mmOSSIO, Ltd.20224—
+6K221489Artemis Proximal Femoral Nail SystemGlw, Inc.20220—
+6K221502Parcus Synd-EZ SSParcus Medical, LLC20220—
+6K220947Arthrex Knotless AC Repair DevicesArthrex, Inc.20223—
+6K220650TriMed Ripcord DeviceTriMed, Inc.202211
+6K211770R3ACT Stabilization SystemParagon 28, Inc.20213—
+6K213596OSSIOfiber Compression Screw, 3.5mmOSSIO, Ltd.20214—
+6K213644Arthrex Knotless Mini TightRopesArthrex, Inc.20211—
+6K203239Arthrex Low Profile ScrewsArthrex, Inc.20200—
+6K202259Parcus GFS II and GFS Mini, GFS Naked, GFS Ultimate, GFS BTB, ATLAS, Synd-EZ Ti…Parcus Medical, LLC20202—
+6K200361Akros Scruture Anchor LisFranc Repair KitAkros Medical20200—
+6K192964Parcus Synd-EZ SSParcus Medical, LLC20191—
+6K190333Paradigm All-Suture Anchor 1.8mm, White/Black #2Conmed Corporation20190—
+6K183232Double ENDOBUTTON Fixation DeviceSmith and Nephew, Inc.20196—
+6K181086Cortical Fixation SystemsCousin Biotech Sas20190—
+6K1811202.8 mm/3.3 mm PopLok Suture AnchorsConmed Corporation20180—
+6K182446TruShot with Y-Knot All-Suture AnchorConmed Corporation20180—
+6K180759SECULOK™ Suture AnchorU&I Corporation20180—
+6K180257InCore® Lapidus SystemNextremity Solutions, Inc.20183—
+6K180243Infinity-Lock Button SystemXiros, Ltd.20180—
+6K172383Arthrosurface Bone ScrewsArthrosurface, Inc.20171—
+6K162996INVISIKNOT Ankle Syndesmosis Repair KitSmith & Nephew, Inc.20172—
+6K170440KISSloc Suture SystemArthrosurface, Inc.20171—
+6K163361ANTHEM™ Fracture SystemGlobus Medical, Inc.201714—
+6K170501CrossFT Knotless Biocomposite Suture Anchor with Disposable DriverConmed Corporation20172—
+6K163258CrossFT Knotless Suture Anchor with Disposable DriverConmed Corporation20179—
+6K153211M-Fix Acromioclavicular DeviceCoracoid Solutions, Inc.20160—
+6K153186Adjustable Fixation DeviceArthrocare Corp.20161—
+6K143092Tensyn PlugDallen Medical, Inc.20151—
+6K143139Arthrex Fracture SystemArthrex, Inc.20151—
+6K141420FastforwardMedShape, Inc.20145—
+6K141264Tensyn Band, Tensyn Fracture PlatesDallen Medical, Inc.20142—
+6K140324Rigidloop Adjustable Cortical Implant: Standard, Long and XLDepuy Mitek, A Johnson and Johnson Company20140—
+6K133835Arthrosurface Kissloc Knotless Suture SystemArthrosurface, Inc.20142—
+6K133606N8TIVE Acl Anatomic Reconstruction System, N8TIVE Acl Femoral Implant, N8TIVE Acl Tibial…ArthroCare Corporation20142—
+6K132867Surelock All-Suture Anchor with Inserter, 1.4MM, Surelock All-Suture Anchor with…Cayenne Medical, Inc.20137—
+6K130033Toggleloc Xtender; Toggleloc XL; Implant Kit Toggleloc; Implant Kit Toggleloc BTB…Biomet Manufacturing Corp2013353
+6K131035Y-Knot Flex All-Suture Anchor, W/ Two #2 (5 Metric) HI-FI Sutures, 1.8MMLinvatec Corporation D/B/A Conmed Linvatec201317—
+6K123241Arthrex Fracture PlatesArthrex, Inc.201371—
+6K123341Arthrex Pec Repair Button, Arthrex Large Pec Button, Arthrex Biceps Button, Arthrex…Arthrex, Inc.201252—
+6K120356NCS Fish-Fit MD System Fish-Fit MD Compass MDNcs Lab Srl20121—
+6K121890Genesys Pressft Suture AnchorLinvatec Corporation D/B/A Conmed Linvatec20120—
+6K112111Acu-Sinch Repair System and Acumed Suture AnchorAcumed, LLC201149—
+6K112965Nano Suture AnchorLinvatec Corporation D/B/A Conmed Linvatec201196
+6K091207Surgicraft Lockdown Acromioclavicular (AC) DeviceSurgicraft, Ltd.20113—
+6K091763Michelangelo Bunion System - Mabs, Model: MA6000Instratek, Inc.20094—
+6K090107Mini TightropeArthrex, Inc.200921—
+6K090075Parcus V-Lox Titanium Suture Anchor,Models: 10251, 10252, 10257, 10258Parcus Medical, LLC200913—
+6K082384Hav-Lok Bunion Correction SystemInstratek, Inc.20085—
+6K081098Endobutton Continuous Loop (CL)Smith & Nephew Inc., Endoscopy Division200831—
+6K070780Conmed Linvatec XO ButtonConmed Linvatec200738—
+6K071978Mini Tightrope FT Repair KitArthrex, Inc.200722—
+7K262537Versalock Sterile Plating SystemGM Dos Reis Industria e Comercio Ltda.20260—
+7K253115Lars AcjMovmedix S.A.S.20260—
+7K254077OSSIOfiber® Threaded Trimmable Fixation NailOSSIO, Ltd.20260—
+7K260390Super Upper Limbs Versalock Plating SystemGM Dos Reis Industria e Comercio Ltda.20261—
+7K253763Y-Knotless™ Flex AnchorsConmed Corporation20261—
+7K253713Arthrex Variable Angle (VA) Proximal Tibia Plating SystemArthrex, Inc.20260—
+7K251161ANTHEM® Fracture SystemGlobus Medical, Inc.20250—
+7K251134RipCordTriMed, Inc.20250—
+7K243368Montblanc Plate SystemMedifield Medical Co., Ltd.20250—
+7K243740Versalock Upper Limb Plating SystemGM Dos Reis Industria e Comercio Ltda.20251—
+7K242091Bolo Button SystemFusion Orthopedics20240—
+7K243408TACTIX Vector Syndesmosis SystemVilex, LLC20240—
+7K241995HyperFlex™ Bunion Correction SystemFootbridge Medical20241—
+7K242998GMReis Ankle Plating SystemGM Dos Reis Industria e Comercio Ltda.20241—
+7K230546SignexOsteonic Co., Ltd.20242—
+7K233531OIC FLEX-FIX™ SystemOrthopaedic Implant Company20240—
+7K232886INFILOOP® Fixed Loop UHMWPE Suture Titanium ButtonHealthium Medtech Limited20230—
+7K232755Arthrex FiberTape and TigerTape Cerclage SuturesArthrex, Inc.20232—
+7K231857Arthrex TightRope IIArthrex, Inc.20234—
+7K223589Grappler Suture Anchor R3FLEX IOL SystemParagon 28, Inc.20232—
+7K222971ULTRABUTTON QUAD Adjustable Fixation Device; ULTRABUTTON BB Adjustable Fixation Device…Smith & Nephew, Inc.20230—
+7K213018Auxilock GFS Mini, GFS II Large, and GFS UltimateAuxein Medical Private Limited20220—
+7K222244Arthrex 3.5 mm Locking Compression PlatesArthrex, Inc.20221—
+7K221485Arthrex FiberTape and TigerTape Cerclage SuturesArthrex, Inc.20225—
+7K220757Argo Knotless SP AnchorConmed Corporation20226—
+7K213837Arthrx Fracture PlatesArthrex, Inc.20220—
+7K212739ActiFlipParcus Medical, LLC20210—
+7K211049Tigon Medical Button SystemTigon Medical20210—
+7K210750Acumed Clavicle Hook Plating SystemAcumed, LLC20210—
+7K202444Knotless TensionTight Button Implant SystemArthrex, Inc.20201—
+7K202496ANTHEM Fracture SystemGlobus Medical, Inc.20208—
+7K201083Parcus V-lox Titanium Suture Anchors, Parcus Miti Suture AnchorsParcus Medical, LLC20203—
+7K200226RetroFixRetrofix Screws, LLC20200—
+7K200124InCore MPJ SystemNextremity Solutions, Inc.20200—
+7K200028Coronet Soft Tissue Fixation SystemConextions Medical20202—
+7K193165MectaFix CL Fixation Button with Continuous LoopMedacta International S.A.20200—
+7K192984APTUS Clavicle SystemMedartis AG20206—
+7K193606Y-Knot OneStep AnchorConmed Corporation20200—
+7K192578InCore TMT SystemNextremity Solutions, Inc.20191—
+7K191426FiberTak ButtonArthrex, Inc.20190—
+7K190143LARS AC Band DeviceCorin USA20191—
+7K190288Arthrex Tenodesis ButtonArthrex, Inc.20194—
+7K190774RIGIDLOOP Titanium Button , RIGIDLOOP Cortical Fixation System XL ImplantMedos International SARL20191—
+7K191204Infinity Fixation SystemConmed Corporation20190—
+7K190231InCore® Lapidus Sterile KitsNextremity Solutions, Inc.20190—
+7K183094CyclaPlex Correction SystemCycla Orthopedics, Ltd.20190—
+7K181076Responsive Arthroscopy Wedge Push-In Suture AnchorsResponsive Arthroscopy, LLC20192—