510(k) Report

Devices descending from K003227

526 later devices reach Bio-Absorbable Corkscrew Model AR-1920B through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K060830Milagro Interference ScrewDepuy Mitek, A Johnson & Johnson Company2006103—
+1K060271Spiralok AnchorDepuy Mitek, A Johnson & Johnson Company200610016
+1K052776Tightrope Acromioclavicular (AC) Device, Titanium, Stainless Steel , Models AR-2257…Arthrex, Inc.2005217—
+1K051250Axya, Model 6500 Axyaloop Bio-Absorbable Bone AnchorAxya Medical, Inc.200511—
+1K043337Arthrex Bio-Corkscrew FT Suture AnchorArthrex, Inc.2004145—
+1K041698Axya Medical, Inc. Model 5000 Axyaloop Bio-Absorbable Bone AnchorAxya Medical, Inc.200414—
+1K030388Impact Suture Anchor. Model 433510Bionx Implants, Ltd.200377—
+1K020056Duet Suture AnchorBionx Implants, Ltd.200278—
+2K242311EXPERT - Flexible Joint Fixation SystemGM Dos Reis Industria e Comercio Ltda.20240—
+2K232941Megaloop Button SystemSuzhou Endophix Co., Ltd.20240—
+2K232780CC-Clip® Implant SystemCc-Instruments, Inc.20230—
+2K220947Arthrex Knotless AC Repair DevicesArthrex, Inc.20223—
+2K191319Dunamis Fixation Button SystemDunamis, LLC20191—
+2K180243Infinity-Lock Button SystemXiros, Ltd.20180—
+2K171299Fixone Biocomposite AnchorAju Pharm Co., Ltd.20174—
+2K161174Nanova Interference ScrewNanova Biomaterials, Inc.20160—
+2K153211M-Fix Acromioclavicular DeviceCoracoid Solutions, Inc.20160—
+2K132733Orthohelix Syndesmosis Fixation DevicesOrthohelix Surgical Designs, Inc.20143—
+2K123362Milagro Advance Interference ScrewDepuy Mitek, A Johnson & Johnson Company20135—
+2K122869Milagro Interference ScrewsDepuy Mitek, A Johnson & Johnson Company20120—
+2K120589Milagro Interference ScrewsDepuy Mitek, A Johnson & Johnson Company20121—
+2K112437Arthrex Fracture SystemArthrex, Inc.201191—
+2K112111Acu-Sinch Repair System and Acumed Suture AnchorAcumed, LLC201149—
+2K112249Healix Knotless (TM) AnchorDepuy Mitek, A Johnson & Johnson Company201113—
+2K103831Depuy Mitek Milagro Interference Screw Model 231803, 231804, 231807, 231809Depuy Mitek, A Johnson & Johnson Company201118—
+2K091207Surgicraft Lockdown Acromioclavicular (AC) DeviceSurgicraft, Ltd.20113—
+2K102410Matryx Interference Screw (5.0-6.5MM)Conmed Linvatec20102—
+2K083268Tornier, Inc., Insite Suture AnchorsTornier, Inc.20097—
+2K082095Ultraslide Acromioclavicular and Syndesmotic Repair DeviceSmith & Nephew Endoscopy, Inc.200859—
+2K081098Endobutton Continuous Loop (CL)Smith & Nephew Inc., Endoscopy Division200831—
+2K073412Gryphon BR and Healix BR AnchorsDepuy Mitek, A Johnson & Johnson Company2008441
+2K071437Megafix-C Bioabsorbable Composite Interference Screw, Model 2870719C, 2870723C…KARL STORZ Endoscopy-America, Inc.20071—
+2K070780Conmed Linvatec XO ButtonConmed Linvatec200738—
+2K071481Healix AnchorDepuy Mitek, A Johnson & Johnson Company200799—
+2K071176Modification to: Arthrex Interference ScrewArthrex, Inc.200747—
+2K070882Stryker Peek Twinloop TacStryker Endoscopy200735—
+2K061925Mini Tightrope Repair Kit, Model AR-8911DSArthrex, Inc.200633—
+2K061949Doubleplay Suture AnchorBiocomposites, Ltd.20060—
+2K061665Arthrex 4.5 MM, 5.5 MM and 6.5 MM Corkscrew FTArthrex, Inc.2006114—
+2K060970Axyaloop Nonabsorbable Bone AnchorAxya Medical, Inc.20061021
+2K053561Bio-Mini Revo Suture AnchorConmed Linvatec200675—
+2K051983Model 3000 Axyaloop Bio-Absorbable Bone AnchorAxya Medical, Inc.20051121
+2K042966Duet Suture Anchor, Models BXS4216, BXS4216H; Impact Suture Anchor, Models BXS4218…Linvatec Biomaterials, Ltd.200476—
+3K261406Versalock Proximal Tibial Plating SystemGM Dos Reis Industria e Comercio Ltda.20261—
+3K253115Lars AcjMovmedix S.A.S.20260—
+3K250867Dunamis Screw and Suture Locking SystemDunamis Medical, LLC20250—
+3K243790GRYPHON™ X Anchor; HEALIX TRANSTEND™ AnchorDepuy Mitek20250—
+3K243665Crius PEEK Suture Anchor System (Thread-Fix Anchor); Crius PEEK Suture Anchor System…ZheJiang Decans Medical Devices Co., Ltd.20250—
+3K240441MILAGRO Interference Screw; MILAGRO ADVANCE Interference ScrewDepuy Mitek20241—
+3K232886INFILOOP® Fixed Loop UHMWPE Suture Titanium ButtonHealthium Medtech Limited20230—
+3K232755Arthrex FiberTape and TigerTape Cerclage SuturesArthrex, Inc.20232—
+3K222574Simparo Anchor Line Fixation SystemSimparo, Inc.20230—
+3K203335MectaScrew ExtensionMedacta International S.A.20220—
+3K212990Acumed Ankle Syndesmosis Repair SystemAcumed, LLC20220—
+3K213644Arthrex Knotless Mini TightRopesArthrex, Inc.20211—
+3K212381VersaTap, VersaLat, DueLock, VersaTi, MiniTiOrtho-Design (Pty), Ltd.20211—
+3K210750Acumed Clavicle Hook Plating SystemAcumed, LLC20210—
+3K203239Arthrex Low Profile ScrewsArthrex, Inc.20200—
+3K200332EXPERT - Joint Fixation SystemGM Dos Reis Industria e Comercio Ltda.20201—
+3K200361Akros Scruture Anchor LisFranc Repair KitAkros Medical20200—
+3K192484Fixone Biocomposite AnchorAju Pharm Co., Ltd.20203—
+3K200028Coronet Soft Tissue Fixation SystemConextions Medical20202—
+3K193165MectaFix CL Fixation Button with Continuous LoopMedacta International S.A.20200—
+3K192984APTUS Clavicle SystemMedartis AG20206—
+3K190143LARS AC Band DeviceCorin USA20191—
+3K191204Infinity Fixation SystemConmed Corporation20190—
+3K183501Parcus Twist AP Suture AnchorsParcus Medical, LLC20192—
+3K183232Double ENDOBUTTON Fixation DeviceSmith and Nephew, Inc.20196—
+3K180972ARIX Clavicle SystemJeil Medical Corporation20181—
+3K181680ICONN Answer II Suture AnchorIconn Orthopedics, LLC20180—
+3K180464AEVUMED PHANTOM Suture AnchorsAevumed, Inc.20184—
+3K180662Arthrex FastThread Interference ScrewArthrex, Inc.20183—
+3K173788Arthrex Corkscrew FTArthrex, Inc.20185—
+3K172383Arthrosurface Bone ScrewsArthrosurface, Inc.20171—
+3K170639HEALIX ADVANCE Anchor with PERMATAPE SutureMedos International SARL20171—
+3K170440KISSloc Suture SystemArthrosurface, Inc.20171—
+3K163361ANTHEM™ Fracture SystemGlobus Medical, Inc.201714—
+3K160804INTRAFIX (TM) Advance Tibial Fastener SystemMedos International SARL20160—
+3K161001MILAGRO ADVANCE PEEK Interference ScrewMedos International SARL20162—
+3K151342Arthrex SwiveLock AnchorsArthrex, Inc.201638—
+3K152236KATOR Suture AnchorKator, LLC20154—
+3K151037GraftMax Button, ALB with Cradle, GraftMax Button, BTB with CradleConmed Corporation20155—
+3K143092Tensyn PlugDallen Medical, Inc.20151—
+3K143172ACL SMART SystemSmith & Nephew, Inc.20150—
+3K143139Arthrex Fracture SystemArthrex, Inc.20151—
+3K141420FastforwardMedShape, Inc.20145—
+3K141264Tensyn Band, Tensyn Fracture PlatesDallen Medical, Inc.20142—
+3K140324Rigidloop Adjustable Cortical Implant: Standard, Long and XLDepuy Mitek, A Johnson and Johnson Company20140—
+3K133835Arthrosurface Kissloc Knotless Suture SystemArthrosurface, Inc.20142—
+3K133579Multifilament Stainless Steel Sutures with CrimpsPontis Orthopaedics, LLC20140—
+3K132632Tornier Insite FT Suture Anchor with NeedlesTornier, Inc.20130—
+3K130814Rigidloop Fixation Device (15MM, 60MM, XL, 20MM, 25MM, 30MM, 35MM, 40MM, 45MM, 50MM, 55MMDepuy Mitek, A Johnson & Johnson Company20133—
+3K130917Healix Advance Knotless BR AnchorDepuy Mitek, A Johnson & Johnson Company201392
+3K130539Healix Advance Knotless Peek Anchor (4.75MM)(5.5MM)Depuy Mitek, A Johnson & Johnson Company20134—
+3K122635Tornier Insite FT Biocomposite Suture AnchorTornier, Inc.20130—
+3K123241Arthrex Fracture PlatesArthrex, Inc.201371—
+3K120509Stryker All Suture AnchorsStryker201227—
+3K120449Healix Advance Peek AnchorDepuy Mitek201250—
+3K113760Variax Superior and Anterior, Lateral and Midshaft Clavicle Plates Variax Aiming Blocks…Howmedica Osteonics Corp., Dba Stryker Orthopaedics201240—
+3K113274Footprint Ultra PK Suture AnchorSmith & Nephew, Inc.201216—