510(k) Report

Devices descending from K071704

142 later devices reach Sleeve and Button Soft Tissue Devices through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K162429ZipE Knotless Tissue Repair and Attachment DevicesZiptek, LLC20175—
+1K110145Biomet Sports Medicine Juggerknot Soft AnchorBiomet, Inc.2011833
+1K101063Sleeve with Ziploop Fixation DevicesBiomet Sports Medicine201031
+1K083070Toggleloc SystemBiomet Sports Medicine2008946
+2K233429OTS 25 (100-1)Ots Medical, Ltd.20232—
+2K200028Coronet Soft Tissue Fixation SystemConextions Medical20202—
+2K191227Paratrooper Plantar Plate Repair SystemParagon 28, Inc.20201—
+2K182898TenoTac Soft Tissue Fixation SystemParagon 28, Inc.20191—
+2K181086Cortical Fixation SystemsCousin Biotech Sas20190—
+2K162996INVISIKNOT Ankle Syndesmosis Repair KitSmith & Nephew, Inc.20172—
+2K153186Adjustable Fixation DeviceArthrocare Corp.20161—
+2K150768JuggerKnot Soft AnchorsBiomet Manufacturing Corp201540—
+2K143092Tensyn PlugDallen Medical, Inc.20151—
+2K141263Toggleloc and Juggerloc Implants/Instruments/KitsBiomet Manufacturing Corp201402
+2K141219Juggerloc Bone to Bone Implants/ Bone Instruments/ Bone Implant and Instrument KitsBiomet Manufacturing Corp20141—
+2K140324Rigidloop Adjustable Cortical Implant: Standard, Long and XLDepuy Mitek, A Johnson and Johnson Company20140—
+2K133606N8TIVE Acl Anatomic Reconstruction System, N8TIVE Acl Femoral Implant, N8TIVE Acl Tibial…ArthroCare Corporation20142—
+2K133858Tensyn BandDallen Medical, Inc.20143—
+2K132733Orthohelix Syndesmosis Fixation DevicesOrthohelix Surgical Designs, Inc.20143—
+2K131850Tensyn BandDallen Medical, Inc.20135—
+2K130033Toggleloc Xtender; Toggleloc XL; Implant Kit Toggleloc; Implant Kit Toggleloc BTB…Biomet Manufacturing Corp2013353
+2K130458Knotless Fibertak Suture AnchorArthrex, Inc.20132—
+2K123485Juggerknotless Soft Anchors, Juggerknotless M Soft Anchors, Juggerknotless Soft Anchors…Biomet Sports Medicine201302
+2K122059All-Suture Anchor Twist Drill for All-Suture Anchors Inline Drill Guide for All-Suture…Smith & Nephew, Inc.201316
+2K122805Parcus Draw Tight 1.8MM Single-Loaded Suture AnchorParcus Medical, LLC20131—
+2K123341Arthrex Pec Repair Button, Arthrex Large Pec Button, Arthrex Biceps Button, Arthrex…Arthrex, Inc.201252—
+2K111779Y-Knot All-Suture Anchor Model HF13Conmed Linvatec201129—
+2K110473Nanotack Suture Anchor 1.4MMPivot Medical20112—
+3K261363Y-Knotless™ Flex AnchorsCONMED Corporation20260—
+3K252081SportLinc Syndesmosis DeviceLincotek Medical20260—
+3K252596Tigon Medical Knotless and Dual Javelin All-Suture AnchorsTigon Medical20251—
+3K251134RipCordTriMed, Inc.20250—
+3K241234OTS 25-L (100-5)Ots Medical, Ltd.20251—
+3K242091Bolo Button SystemFusion Orthopedics20240—
+3K233531OIC FLEX-FIX™ SystemOrthopaedic Implant Company20240—
+3K231857Arthrex TightRope IIArthrex, Inc.20234—
+3K220966SinefixBAAT Medical Products B.V.20231—
+3K222971ULTRABUTTON QUAD Adjustable Fixation Device; ULTRABUTTON BB Adjustable Fixation Device…Smith & Nephew, Inc.20230—
+3K213109Auxilock Draw Tight Suture-Based AnchorAuxein Medical Private Limited20220—
+3K220650TriMed Ripcord DeviceTriMed, Inc.202211
+3K211770R3ACT Stabilization SystemParagon 28, Inc.20213—
+3K211322Paratrooper Plantar Plate Repair SystemParagon 28, Inc.20210—
+3K211049Tigon Medical Button SystemTigon Medical20210—
+3K203121Responsive Arthroscopy Thunderbolt SystemResponsive Arthroscopy, LLC20211—
+3K203740JuggerKnot Soft AnchorRiverpoint Medical20215—
+3K203385TenoTac Soft Tissue Fixation SystemParagon 28, Inc.20210—
+3K203485SnugFit All-Suture AnchorMedacta International S.A.20212—
+3K202444Knotless TensionTight Button Implant SystemArthrex, Inc.20201—
+3K193461MectaLock All-Suture AnchorsMedacta International S.A.20203—
+3K191426FiberTak ButtonArthrex, Inc.20190—
+3K190288Arthrex Tenodesis ButtonArthrex, Inc.20194—
+3K190774RIGIDLOOP Titanium Button , RIGIDLOOP Cortical Fixation System XL ImplantMedos International SARL20191—
+3K190728Arthrex SwiveLock AnchorsArthrex, Inc.20192—
+3K190333Paradigm All-Suture Anchor 1.8mm, White/Black #2Conmed Corporation20190—
+3K182446TruShot with Y-Knot All-Suture AnchorConmed Corporation20180—
+3K180768Arthrex SwiveLock AnchorsArthrex, Inc.201828—
+3K173278ToggleLoc SystemBiomet, Inc.20183—
+3K172620SyndesMetrics Syndesmosis Repair SystemMortise Medical, LLC20170—
+3K170440KISSloc Suture SystemArthrosurface, Inc.20171—
+3K163034SUTUREFIX Curved Suture AnchorSmith and Nephew, Inc.20160—
+3K153558Ventix Suture AnchorBiomet Manufacturing Corp20160—
+3K153211M-Fix Acromioclavicular DeviceCoracoid Solutions, Inc.20160—
+3K151004PULLUP® Adjustable Juxtacortical Fixation DeviceSbm Sciences For Bio Materials20152—
+3K150359Tensyn PlugDallen Medical, Inc.20150—
+3K141264Tensyn Band, Tensyn Fracture PlatesDallen Medical, Inc.20142—
+3K132867Surelock All-Suture Anchor with Inserter, 1.4MM, Surelock All-Suture Anchor with…Cayenne Medical, Inc.20137—
+3K131035Y-Knot Flex All-Suture Anchor, W/ Two #2 (5 Metric) HI-FI Sutures, 1.8MMLinvatec Corporation D/B/A Conmed Linvatec201317—
+3K130351Nanotack Suture Anchor 1.4MM with Flex InserterPivot Medical, Inc.20130—
+3K123651Cinchlock Knotless Suture AnchorPivot Medical20130—
+3K120356NCS Fish-Fit MD System Fish-Fit MD Compass MDNcs Lab Srl20121—
+4K253065Aevumed SUPERCYNCH™ Button SystemAevumed, Inc.20260—
+4K261632Thunderbolt SystemResponsive Arthroscopy, Inc.20260—
+4K260921Tigon Medical Static Javelin All-Suture Anchors & Javelin All-Suture Anchor LineTigon Medical20260—
+4K254176SinefixBAAT Medical Products B.V.20260—
+4K253763Y-Knotless™ Flex AnchorsConmed Corporation20261—
+4K251310OTS 25-L (100-5)Ots Medical, Ltd.20250—
+4K251933SnugFit ASA ExtensionMedacta International S.A.20250—
+4K250844PULLUP®; PULLUP® CLIP; BT LOOP®; PULLUP® TEX CLIP; RIGIDLOOP™ T; RIGIDLOOP™ Clip…Science & Bio Materials (S.B.M.) Sas20250—
+4K242494OsseoFit Interfacing Anchor; OsseoFit Bone Tunnel ConstructRiverpoint Medical, LLC20240—
+4K240035TACTIX Vector Syndesmosis SystemVilex, LLC20241—
+4K240947TENSOR® Suture Button SystemGlobus Medical, Inc.20240—
+4K241235Arthrex TightRope IIArthrex, Inc.20243—
+4K232941Megaloop Button SystemSuzhou Endophix Co., Ltd.20240—
+4K232973Arthrex Knee FiberTak® Button Suture AnchorArthrex, Inc.20234—
+4K232411JuggerKnot Soft Anchor OCRiverpoint Medical, LLC20232—
+4K231128JuggerKnot Soft AnchorRiverpoint Medical, LLC20230—
+4K230544SnugFit All-Suture Anchor extensionMedacta International S.A.20231—
+4K223589Grappler Suture Anchor R3FLEX IOL SystemParagon 28, Inc.20232—
+4K220260Hercules Syndesmosis Implant SystemIn2bones USA, LLC20220—
+4K212381VersaTap, VersaLat, DueLock, VersaTi, MiniTiOrtho-Design (Pty), Ltd.20211—
+4K202193PULLUP BTB Adjustable Fixation System for Ligament Reconstruction, PULLUP CLIP…S.B.M. Sas (Science & Bio Materials)20201—
+4K193606Y-Knot OneStep AnchorConmed Corporation20200—
+4K192750AcTiFlip Naked, AcTiFlip Cinch, AcTiFlip WHIP, GFS Ultimate HipParcus Medical, LLC20203—
+4K192441Arthrex SwiveLock AnchorsArthrex, Inc.20192—
+4K191226Arthrex SwiveLock Suture AnchorArthrex, Inc.201921—
+4K160500Elite SPK, Compasso, Elite SPK KitNcs Lab Srl20160—
+4K151068SureLock W Suture AnchorCayenne Medical, Inc.20156—
+4K133224Y-Knot RC All-Suture Anchor, 2.8MM - Double Loaded and Triple Loaded W/ #2 Hifi SuturesConmed Corporation201412—
+5K260405FiberTape ButtonArthrex, Inc.20260—
+5K250867Dunamis Screw and Suture Locking SystemDunamis Medical, LLC20250—