510(k) Report

Devices descending from K973015

393 later devices reach Multitak SS Suture System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K101063Sleeve with Ziploop Fixation DevicesBiomet Sports Medicine201031
+1K080088Biomet Sports Medicine Anchor Devices and Ziploop ConstructsBiomet Manufacturing, Inc.200868
+1K071704Sleeve and Button Soft Tissue DevicesBiomet Sports Medicine, Inc.2007142—
+1K993115Multitak SSBonutti Research, Inc.19994—
+1K990156Multitak SS ButtonsBonutti Research1999336—
+2K193402ALLthread PEEK Suture AnchorBiomet, Inc.20200—
+2K192942ALLthread Titanium Suture AnchorBiomet, Inc.20200—
+2K162429ZipE Knotless Tissue Repair and Attachment DevicesZiptek, LLC20175—
+2K123485Juggerknotless Soft Anchors, Juggerknotless M Soft Anchors, Juggerknotless Soft Anchors…Biomet Sports Medicine201302
+2K110473Nanotack Suture Anchor 1.4MMPivot Medical20112—
+2K110145Biomet Sports Medicine Juggerknot Soft AnchorBiomet, Inc.2011833
+2K083070Toggleloc SystemBiomet Sports Medicine2008946
+2K033717Transet Fracture Fixation SystemBonutti Research, Inc.2004309—
+2K031666Arthrex Fiberwire Button Repair Kit, Model AR-8920DS/AR-8921DSArthrex, Inc.20031611
+2K011985Smith & Nephew Phoenix 5.0 Allograft Anchor KitSmith & Nephew, Inc.20013—
+3K233429OTS 25 (100-1)Ots Medical, Ltd.20232—
+3K200028Coronet Soft Tissue Fixation SystemConextions Medical20202—
+3K191227Paratrooper Plantar Plate Repair SystemParagon 28, Inc.20201—
+3K182898TenoTac Soft Tissue Fixation SystemParagon 28, Inc.20191—
+3K181086Cortical Fixation SystemsCousin Biotech Sas20190—
+3K162996INVISIKNOT Ankle Syndesmosis Repair KitSmith & Nephew, Inc.20172—
+3K153186Adjustable Fixation DeviceArthrocare Corp.20161—
+3K150768JuggerKnot Soft AnchorsBiomet Manufacturing Corp201540—
+3K143092Tensyn PlugDallen Medical, Inc.20151—
+3K141263Toggleloc and Juggerloc Implants/Instruments/KitsBiomet Manufacturing Corp201402
+3K141219Juggerloc Bone to Bone Implants/ Bone Instruments/ Bone Implant and Instrument KitsBiomet Manufacturing Corp20141—
+3K140324Rigidloop Adjustable Cortical Implant: Standard, Long and XLDepuy Mitek, A Johnson and Johnson Company20140—
+3K133606N8TIVE Acl Anatomic Reconstruction System, N8TIVE Acl Femoral Implant, N8TIVE Acl Tibial…ArthroCare Corporation20142—
+3K133858Tensyn BandDallen Medical, Inc.20143—
+3K132733Orthohelix Syndesmosis Fixation DevicesOrthohelix Surgical Designs, Inc.20143—
+3K131850Tensyn BandDallen Medical, Inc.20135—
+3K130033Toggleloc Xtender; Toggleloc XL; Implant Kit Toggleloc; Implant Kit Toggleloc BTB…Biomet Manufacturing Corp2013353
+3K130458Knotless Fibertak Suture AnchorArthrex, Inc.20132—
+3K122059All-Suture Anchor Twist Drill for All-Suture Anchors Inline Drill Guide for All-Suture…Smith & Nephew, Inc.201316
+3K130351Nanotack Suture Anchor 1.4MM with Flex InserterPivot Medical, Inc.20130—
+3K123651Cinchlock Knotless Suture AnchorPivot Medical20130—
+3K122805Parcus Draw Tight 1.8MM Single-Loaded Suture AnchorParcus Medical, LLC20131—
+3K123341Arthrex Pec Repair Button, Arthrex Large Pec Button, Arthrex Biceps Button, Arthrex…Arthrex, Inc.201252—
+3K111779Y-Knot All-Suture Anchor Model HF13Conmed Linvatec201129—
+3K100652Acl TightropeArthrex, Inc.201065—
+3K090107Mini TightropeArthrex, Inc.200921—
+3K081348Tenodesis Cross Screw, Interference Screw, Suture BeadTriMed, Inc.20081—
+3K062747Arthrex Retrobutton, 15MM, 60MM, Retrobutton, Long, 15MM, 60MMArthrex, Inc.2006143—
+3K061498Allofix Anchor, 5.0 MM AnchorMusculoskeletal Transplant Foundation200601
+3K052901Arthrex TensionlokArthrex, Inc.20050—
+3K043248Tightrope Syndesmosis Repair Kit, Titanium, Model AR-8920DS; Stainless Steel. Model…Arthrex, Inc.2005306—
+3K042038MTF Allograft AnchorMusculoskeletal Transplant Foundation20041—
+4K261363Y-Knotless™ Flex AnchorsCONMED Corporation20260—
+4K252081SportLinc Syndesmosis DeviceLincotek Medical20260—
+4K253727Syndesmosis TightRope PROArthrex, Inc.20250—
+4K252596Tigon Medical Knotless and Dual Javelin All-Suture AnchorsTigon Medical20251—
+4K251134RipCordTriMed, Inc.20250—
+4K241234OTS 25-L (100-5)Ots Medical, Ltd.20251—
+4K242091Bolo Button SystemFusion Orthopedics20240—
+4K241995HyperFlex™ Bunion Correction SystemFootbridge Medical20241—
+4K242311EXPERT - Flexible Joint Fixation SystemGM Dos Reis Industria e Comercio Ltda.20240—
+4K232941Megaloop Button SystemSuzhou Endophix Co., Ltd.20240—
+4K233531OIC FLEX-FIX™ SystemOrthopaedic Implant Company20240—
+4K231857Arthrex TightRope IIArthrex, Inc.20234—
+4K220966SinefixBAAT Medical Products B.V.20231—
+4K222971ULTRABUTTON QUAD Adjustable Fixation Device; ULTRABUTTON BB Adjustable Fixation Device…Smith & Nephew, Inc.20230—
+4K213109Auxilock Draw Tight Suture-Based AnchorAuxein Medical Private Limited20220—
+4K220650TriMed Ripcord DeviceTriMed, Inc.202211
+4K220260Hercules Syndesmosis Implant SystemIn2bones USA, LLC20220—
+4K212990Acumed Ankle Syndesmosis Repair SystemAcumed, LLC20220—
+4K211770R3ACT Stabilization SystemParagon 28, Inc.20213—
+4K213644Arthrex Knotless Mini TightRopesArthrex, Inc.20211—
+4K211322Paratrooper Plantar Plate Repair SystemParagon 28, Inc.20210—
+4K211049Tigon Medical Button SystemTigon Medical20210—
+4K203121Responsive Arthroscopy Thunderbolt SystemResponsive Arthroscopy, LLC20211—
+4K203740JuggerKnot Soft AnchorRiverpoint Medical20215—
+4K203385TenoTac Soft Tissue Fixation SystemParagon 28, Inc.20210—
+4K203485SnugFit All-Suture AnchorMedacta International S.A.20212—
+4K202444Knotless TensionTight Button Implant SystemArthrex, Inc.20201—
+4K200332EXPERT - Joint Fixation SystemGM Dos Reis Industria e Comercio Ltda.20201—
+4K201522Arthrex Syndesmosis TightRope XP Buttress Plate Implant SystemArthrex, Inc.20207—
+4K193461MectaLock All-Suture AnchorsMedacta International S.A.20203—
+4K191426FiberTak ButtonArthrex, Inc.20190—
+4K191783Parcus Synd-EZ TiParcus Medical, LLC20195—
+4K190288Arthrex Tenodesis ButtonArthrex, Inc.20194—
+4K191319Dunamis Fixation Button SystemDunamis, LLC20191—
+4K190774RIGIDLOOP Titanium Button , RIGIDLOOP Cortical Fixation System XL ImplantMedos International SARL20191—
+4K190728Arthrex SwiveLock AnchorsArthrex, Inc.20192—
+4K190333Paradigm All-Suture Anchor 1.8mm, White/Black #2Conmed Corporation20190—
+4K182446TruShot with Y-Knot All-Suture AnchorConmed Corporation20180—
+4K180768Arthrex SwiveLock AnchorsArthrex, Inc.201828—
+4K173910Impress SFS SystemCable Fix Medical, LLC20180—
+4K171703PUMA SystemPanther Orthopedics, Inc.20180—
+4K173278ToggleLoc SystemBiomet, Inc.20183—
+4K173550Akros FibuLink™ Syndesmosis Repair KitAkros Medical20174—
+4K172620SyndesMetrics Syndesmosis Repair SystemMortise Medical, LLC20170—
+4K170388ANCHORMAN Tibial Ligament Fixation DeviceSummit Medical, Ltd.20170—
+4K170249GRAVITY™ Syndesmosis LPWrightmedicaltechnologyinc20172—
+4K170440KISSloc Suture SystemArthrosurface, Inc.20171—
+4K162805Akros Fibulink Syndesmosis Repair KitAkros Medical20175—
+4K163034SUTUREFIX Curved Suture AnchorSmith and Nephew, Inc.20160—
+4K153558Ventix Suture AnchorBiomet Manufacturing Corp20160—
+4K153211M-Fix Acromioclavicular DeviceCoracoid Solutions, Inc.20160—
+4K151004PULLUP® Adjustable Juxtacortical Fixation DeviceSbm Sciences For Bio Materials20152—
+4K150359Tensyn PlugDallen Medical, Inc.20150—