510(k) Report

Devices descending from K961555

584 later devices reach Acufex Tag Bioabsorbable Anchors through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+6K220966SinefixBAAT Medical Products B.V.20231—
+6K222971ULTRABUTTON QUAD Adjustable Fixation Device; ULTRABUTTON BB Adjustable Fixation Device…Smith & Nephew, Inc.20230—
+6K220650TriMed Ripcord DeviceTriMed, Inc.202211
+6K220757Argo Knotless SP AnchorConmed Corporation20226—
+6K213958Bioabsorbable AnchorEmbody, Inc.20220—
+6K213415OSSIOfiber Suture AnchorOSSIO, Ltd.20223—
+6K212594OSSIOfiber® StapleOSSIO, Ltd.20222—
+6K211770R3ACT Stabilization SystemParagon 28, Inc.20213—
+6K212912OneFix Biocomposite Anchors, OneFix Biocomposite Small Anchors, OneFix All Suture…B-One Ortho, Corp.20210—
+6K211322Paratrooper Plantar Plate Repair SystemParagon 28, Inc.20210—
+6K211049Tigon Medical Button SystemTigon Medical20210—
+6K202806Fix2Lock (Biocomposite medial, Biocomposite lateral, Biocombi Self Punching)Osteonic Co., Ltd.20212—
+6K203121Responsive Arthroscopy Thunderbolt SystemResponsive Arthroscopy, LLC20211—
+6K210498Betta Link Knotless Implant SystemT.A.G. Medical Products Corporation, Ltd.202101
+6K203740JuggerKnot Soft AnchorRiverpoint Medical20215—
+6K203385TenoTac Soft Tissue Fixation SystemParagon 28, Inc.20210—
+6K203485SnugFit All-Suture AnchorMedacta International S.A.20212—
+6K202883Sterile bone screw (PEEK ACL screw)Osteonic Co., Ltd.20200—
+6K202178VersaLoop Anchor SystemT.A.G. Medical Products Corporation, Ltd.20200—
+6K200503ATL AnchorsInternational Life Sciences202022
+6K201749Arthrex SwiveLock AnchorArthrex, Inc.202015—
+6K201786Arthrex Mini Hip PushLockArthrex, Inc.20205—
+6K193108Bonecam Suture AnchorValeris Medical, Inc.20200—
+6K193558HEALICOIL Knotless Suture AnchorsSmith & Nephew, Inc.20200—
+6K200341Arthrex FiberTak Suture AnchorArthrex, Inc.202017—
+6K192484Fixone Biocomposite AnchorAju Pharm Co., Ltd.20203—
+6K191709V-STRUT Vertebral ImplantHyprevention Sas20202—
+6K193461MectaLock All-Suture AnchorsMedacta International S.A.20203—
+6K193606Y-Knot OneStep AnchorConmed Corporation20200—
+6K191426FiberTak ButtonArthrex, Inc.20190—
+6K190288Arthrex Tenodesis ButtonArthrex, Inc.20194—
+6K190774RIGIDLOOP Titanium Button , RIGIDLOOP Cortical Fixation System XL ImplantMedos International SARL20191—
+6K190892MectaScrew PEEK Interference ScrewMedacta International S.A.20191—
+6K190728Arthrex SwiveLock AnchorsArthrex, Inc.20192—
+6K183501Parcus Twist AP Suture AnchorsParcus Medical, LLC20192—
+6K182621CrossFT Knotless Deep Thread Suture Anchor with Disposable DriverConmed Corporation20190—
+6K182736OIC Suture Anchor SystemThe Orthopaedic Implant Company20180—
+6K180768Arthrex SwiveLock AnchorsArthrex, Inc.201828—
+6K180573Responsive Arthroscopy Interference Screw SystemResponsive Arthroscopy, LLC20182—
+6K181262SpineJack Expansion KitVexim SA20184—
+6K173845Arthrex SwiveLockArthrex, Inc.20188—
+6K181083Stryker All-PEEK Knotless Anchor SystemStryker201812
+6K173074ICONIX XBraid TT with Needles, NanoTack TT Suture AnchorStryker20185—
+6K173788Arthrex Corkscrew FTArthrex, Inc.20185—
+6K173278ToggleLoc SystemBiomet, Inc.20183—
+6K170868FIXIT Threaded Anchor SystemS.B.M Sas Science For Bio Materials20172—
+6K172620SyndesMetrics Syndesmosis Repair SystemMortise Medical, LLC20170—
+6K172612FiberTak DXArthex, Inc.20170—
+6K171725CuffLink Implant SystemConmed Corporation20170—
+6K171592CrossFT™ Knotless Biocomposite Suture Anchor with Disposable DriverConmed Corporation20171—
+6K170639HEALIX ADVANCE Anchor with PERMATAPE SutureMedos International SARL20171—
+6K171141Arthrex SwiveLock AnchorsArthrex, Inc.201729—
+6K170440KISSloc Suture SystemArthrosurface, Inc.20171—
+6K163440Stealth Staple SystemFirst Ray, LLC20173—
+6K163034SUTUREFIX Curved Suture AnchorSmith and Nephew, Inc.20160—
+6K153558Ventix Suture AnchorBiomet Manufacturing Corp20160—
+6K160500Elite SPK, Compasso, Elite SPK KitNcs Lab Srl20160—
+6K153482KLS Martin Thoracic Plating SystemKLS-Martin L.P.20169—
+6K151983KLS Martin LSS Plating SystemKLS Martin L.P.201645—
+6K153211M-Fix Acromioclavicular DeviceCoracoid Solutions, Inc.20160—
+6K151004PULLUP® Adjustable Juxtacortical Fixation DeviceSbm Sciences For Bio Materials20152—
+6K143582Mopylen, Resopren, Silk, Polyester, Nylon, Resolon, Polyamide Pseudo, SteelResorba Medical GmbH20150—
+6K151220Dunamis Interference ScrewDunamis, LLC20150—
+6K151068SureLock W Suture AnchorCayenne Medical, Inc.20156—
+6K151314CinchLock Flex Knotless Suture AnchorPivot Medical201502
+6K151230Arthrex FiberTak AnchorsArthrex, Inc.201527—
+6K150359Tensyn PlugDallen Medical, Inc.20150—
+6K142948BIOSURE REGENESORB interference ScrewSmith & Nephew, Inc.201501
+6K142484Sternal Closure SystemJace Medical, LLC20141—
+6K141264Tensyn Band, Tensyn Fracture PlatesDallen Medical, Inc.20142—
+6K141141Kiva VCF Treatment SystemBenvenue Medical, Inc.20140—
+6K140879Biosure Healicoil PK Interference ScrewSmith & Nephew, Inc.20141—
+6K133304RXG Distraction SystemKLS-Martin L.P.20140—
+6K133036Apollo Suture Anchor System and Titan ScrewsAmendia, Inc.201471
+6K133671Iconix All Suture AnchorsStryker Corp.201425—
+6K133224Y-Knot RC All-Suture Anchor, 2.8MM - Double Loaded and Triple Loaded W/ #2 Hifi SuturesConmed Corporation201412—
+6K1325905.5MM Multifix S Knotless Fixation Device, 6.5MM Multifix S Knotless Fixation Device…ArthroCare Corporation20133—
+6K131974Healix Advance Knotless BR Anchor (6.5MM)Depuy Mitek, A Johnson & Johnson Company20133—
+6K123240Speedlock Hip Knotless Fixation ImplantArthroCare Corporation20130—
+6K122596Arthroscopic Surgical Instruments - Interference Screw SystemsSmith & Nephew, Inc.20120—
+6K122860KLS Martin Recon TalonKLS Martin L.P.201210—
+6K122314Quatro Link Knotless Anchor with Inserter, 2.9MM-Peek OnlyCayenne Medical, Inc.20126—
+6K120078Healix Advance BR AnchorDepuy Mitek Inc., Johnson and Johnson Company20129—
+6K113591Cols PeekFournitures Hospitalieres Industrie20110—
+6K113299Rog Suture AnchorRog Sports Medicine, Inc.20112—
+6K112991Modified Rog Suture AnchorRog Sports Medicine, Inc.20111—
+6K1107815.5 / 6.5MM Spartan Peek Surture Implant with #2 Magnumwire / with Needles, Extraction…Arthrocare Corp.20110—
+6K101484Compressyn BandDallen Medical20115—
+6K110660Arthrex Biocomposite SuturetakArthrex, Inc.201164—
+6K103712Gryphon Peek DS Anchor W/ Orthocord, Gryphon Peek Anchor W/ OrthocordDepuy Mitek, A Johnson & Johnson Company20116—
+6K1101645.5MM Spartan Peek Suture Implant W/ #2 Magnum Wire, Punch Tap, Extraction ToolArthrocare Corp.20111—
+6K102298Transtend BR Anchor W/ Orthocord, Transtend TI Anchor W/Orthocord, Transtend Peek Anchor…Depuy Mitek, A Johnson & Johnson Company201115—
+6K101835Medpor Fixation System-Cranial, Models 80080, 80079Porex Surgical, Inc.20100—
+6K100012Gryphon T BR DS Anchor W/Orthocord, Gryphon T BR Anchor W /Orthocord, Gryphon P BR DS…Depuy Mitek, A Johnson & Johnson Company201024—
+6K093943Biosure Sync Tibial Fixation Device, 6MM, 8MM,10MM,12MMSmith & Nephew Inc., Endoscopy Div.20101—
+6K093228Smith & Nephew Twinfix Ultra PK Suture AnchorSmith & Nephew, Inc.200919—
+6K091094Parcus V-Lox Peek CF Suture Anchor, Models: 10253, 10254, 10263, 10264Parcus Medical, LLC20097—
+6K091093Parcus Ppek CF Interference ScrewParcus Medical, LLC20094—
+6K090124Gryphon P BR DS Anchor W/Orthocord,Gryphon P BR Anchor W/Orthocord, Model 210813,210814Depuy Mitek, A Johnson & Johnson Company2009252
+7K261869Integrity Retractable Implant Inserter (6000127)Anika Therapeutics, Inc.20260—