510(k) Report

Devices descending from K934183

396 later devices reach Bonutti Anchor through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K973015Multitak SS Suture SystemBonutti Research1997393—
+1K971144Multitak SS Suture SystemBonutti Research19970—
+1K964324Multitak SS Suture SystemBonutti Research19970—
+2K101063Sleeve with Ziploop Fixation DevicesBiomet Sports Medicine201031
+2K080088Biomet Sports Medicine Anchor Devices and Ziploop ConstructsBiomet Manufacturing, Inc.200868
+2K071704Sleeve and Button Soft Tissue DevicesBiomet Sports Medicine, Inc.2007142—
+2K993115Multitak SSBonutti Research, Inc.19994—
+2K990156Multitak SS ButtonsBonutti Research1999336—
+3K193402ALLthread PEEK Suture AnchorBiomet, Inc.20200—
+3K192942ALLthread Titanium Suture AnchorBiomet, Inc.20200—
+3K162429ZipE Knotless Tissue Repair and Attachment DevicesZiptek, LLC20175—
+3K123485Juggerknotless Soft Anchors, Juggerknotless M Soft Anchors, Juggerknotless Soft Anchors…Biomet Sports Medicine201302
+3K110473Nanotack Suture Anchor 1.4MMPivot Medical20112—
+3K110145Biomet Sports Medicine Juggerknot Soft AnchorBiomet, Inc.2011833
+3K083070Toggleloc SystemBiomet Sports Medicine2008946
+3K033717Transet Fracture Fixation SystemBonutti Research, Inc.2004309—
+3K031666Arthrex Fiberwire Button Repair Kit, Model AR-8920DS/AR-8921DSArthrex, Inc.20031611
+3K011985Smith & Nephew Phoenix 5.0 Allograft Anchor KitSmith & Nephew, Inc.20013—
+4K233429OTS 25 (100-1)Ots Medical, Ltd.20232—
+4K200028Coronet Soft Tissue Fixation SystemConextions Medical20202—
+4K191227Paratrooper Plantar Plate Repair SystemParagon 28, Inc.20201—
+4K182898TenoTac Soft Tissue Fixation SystemParagon 28, Inc.20191—
+4K181086Cortical Fixation SystemsCousin Biotech Sas20190—
+4K162996INVISIKNOT Ankle Syndesmosis Repair KitSmith & Nephew, Inc.20172—
+4K153186Adjustable Fixation DeviceArthrocare Corp.20161—
+4K150768JuggerKnot Soft AnchorsBiomet Manufacturing Corp201540—
+4K143092Tensyn PlugDallen Medical, Inc.20151—
+4K141263Toggleloc and Juggerloc Implants/Instruments/KitsBiomet Manufacturing Corp201402
+4K141219Juggerloc Bone to Bone Implants/ Bone Instruments/ Bone Implant and Instrument KitsBiomet Manufacturing Corp20141—
+4K140324Rigidloop Adjustable Cortical Implant: Standard, Long and XLDepuy Mitek, A Johnson and Johnson Company20140—
+4K133606N8TIVE Acl Anatomic Reconstruction System, N8TIVE Acl Femoral Implant, N8TIVE Acl Tibial…ArthroCare Corporation20142—
+4K133858Tensyn BandDallen Medical, Inc.20143—
+4K132733Orthohelix Syndesmosis Fixation DevicesOrthohelix Surgical Designs, Inc.20143—
+4K131850Tensyn BandDallen Medical, Inc.20135—
+4K130033Toggleloc Xtender; Toggleloc XL; Implant Kit Toggleloc; Implant Kit Toggleloc BTB…Biomet Manufacturing Corp2013353
+4K130458Knotless Fibertak Suture AnchorArthrex, Inc.20132—
+4K122059All-Suture Anchor Twist Drill for All-Suture Anchors Inline Drill Guide for All-Suture…Smith & Nephew, Inc.201316
+4K130351Nanotack Suture Anchor 1.4MM with Flex InserterPivot Medical, Inc.20130—
+4K123651Cinchlock Knotless Suture AnchorPivot Medical20130—
+4K122805Parcus Draw Tight 1.8MM Single-Loaded Suture AnchorParcus Medical, LLC20131—
+4K123341Arthrex Pec Repair Button, Arthrex Large Pec Button, Arthrex Biceps Button, Arthrex…Arthrex, Inc.201252—
+4K111779Y-Knot All-Suture Anchor Model HF13Conmed Linvatec201129—
+4K100652Acl TightropeArthrex, Inc.201065—
+4K090107Mini TightropeArthrex, Inc.200921—
+4K081348Tenodesis Cross Screw, Interference Screw, Suture BeadTriMed, Inc.20081—
+4K062747Arthrex Retrobutton, 15MM, 60MM, Retrobutton, Long, 15MM, 60MMArthrex, Inc.2006143—
+4K061498Allofix Anchor, 5.0 MM AnchorMusculoskeletal Transplant Foundation200601
+4K052901Arthrex TensionlokArthrex, Inc.20050—
+4K043248Tightrope Syndesmosis Repair Kit, Titanium, Model AR-8920DS; Stainless Steel. Model…Arthrex, Inc.2005306—
+4K042038MTF Allograft AnchorMusculoskeletal Transplant Foundation20041—
+5K261363Y-Knotless™ Flex AnchorsCONMED Corporation20260—
+5K252081SportLinc Syndesmosis DeviceLincotek Medical20260—
+5K253727Syndesmosis TightRope PROArthrex, Inc.20250—
+5K252596Tigon Medical Knotless and Dual Javelin All-Suture AnchorsTigon Medical20251—
+5K251134RipCordTriMed, Inc.20250—
+5K241234OTS 25-L (100-5)Ots Medical, Ltd.20251—
+5K242091Bolo Button SystemFusion Orthopedics20240—
+5K241995HyperFlex™ Bunion Correction SystemFootbridge Medical20241—
+5K242311EXPERT - Flexible Joint Fixation SystemGM Dos Reis Industria e Comercio Ltda.20240—
+5K232941Megaloop Button SystemSuzhou Endophix Co., Ltd.20240—
+5K233531OIC FLEX-FIX™ SystemOrthopaedic Implant Company20240—
+5K231857Arthrex TightRope IIArthrex, Inc.20234—
+5K220966SinefixBAAT Medical Products B.V.20231—
+5K222971ULTRABUTTON QUAD Adjustable Fixation Device; ULTRABUTTON BB Adjustable Fixation Device…Smith & Nephew, Inc.20230—
+5K213109Auxilock Draw Tight Suture-Based AnchorAuxein Medical Private Limited20220—
+5K220650TriMed Ripcord DeviceTriMed, Inc.202211
+5K220260Hercules Syndesmosis Implant SystemIn2bones USA, LLC20220—
+5K212990Acumed Ankle Syndesmosis Repair SystemAcumed, LLC20220—
+5K211770R3ACT Stabilization SystemParagon 28, Inc.20213—
+5K213644Arthrex Knotless Mini TightRopesArthrex, Inc.20211—
+5K211322Paratrooper Plantar Plate Repair SystemParagon 28, Inc.20210—
+5K211049Tigon Medical Button SystemTigon Medical20210—
+5K203121Responsive Arthroscopy Thunderbolt SystemResponsive Arthroscopy, LLC20211—
+5K203740JuggerKnot Soft AnchorRiverpoint Medical20215—
+5K203385TenoTac Soft Tissue Fixation SystemParagon 28, Inc.20210—
+5K203485SnugFit All-Suture AnchorMedacta International S.A.20212—
+5K202444Knotless TensionTight Button Implant SystemArthrex, Inc.20201—
+5K200332EXPERT - Joint Fixation SystemGM Dos Reis Industria e Comercio Ltda.20201—
+5K201522Arthrex Syndesmosis TightRope XP Buttress Plate Implant SystemArthrex, Inc.20207—
+5K193461MectaLock All-Suture AnchorsMedacta International S.A.20203—
+5K191426FiberTak ButtonArthrex, Inc.20190—
+5K191783Parcus Synd-EZ TiParcus Medical, LLC20195—
+5K190288Arthrex Tenodesis ButtonArthrex, Inc.20194—
+5K191319Dunamis Fixation Button SystemDunamis, LLC20191—
+5K190774RIGIDLOOP Titanium Button , RIGIDLOOP Cortical Fixation System XL ImplantMedos International SARL20191—
+5K190728Arthrex SwiveLock AnchorsArthrex, Inc.20192—
+5K190333Paradigm All-Suture Anchor 1.8mm, White/Black #2Conmed Corporation20190—
+5K182446TruShot with Y-Knot All-Suture AnchorConmed Corporation20180—
+5K180768Arthrex SwiveLock AnchorsArthrex, Inc.201828—
+5K173910Impress SFS SystemCable Fix Medical, LLC20180—
+5K171703PUMA SystemPanther Orthopedics, Inc.20180—
+5K173278ToggleLoc SystemBiomet, Inc.20183—
+5K173550Akros FibuLink™ Syndesmosis Repair KitAkros Medical20174—
+5K172620SyndesMetrics Syndesmosis Repair SystemMortise Medical, LLC20170—
+5K170388ANCHORMAN Tibial Ligament Fixation DeviceSummit Medical, Ltd.20170—
+5K170249GRAVITY™ Syndesmosis LPWrightmedicaltechnologyinc20172—
+5K170440KISSloc Suture SystemArthrosurface, Inc.20171—
+5K162805Akros Fibulink Syndesmosis Repair KitAkros Medical20175—
+5K163034SUTUREFIX Curved Suture AnchorSmith and Nephew, Inc.20160—
+5K153558Ventix Suture AnchorBiomet Manufacturing Corp20160—