510(k) Report

Devices descending from K033838

97 later devices reach Titanium Toggle Button (S) through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K083070Toggleloc SystemBiomet Sports Medicine2008946
+1K053461Ezloc Femoral Fixation DeviceArthrotek, Inc.20060—
+1K041261Femoral HookArthrotek, Inc.200412
+2K181086Cortical Fixation SystemsCousin Biotech Sas20190—
+2K162996INVISIKNOT Ankle Syndesmosis Repair KitSmith & Nephew, Inc.20172—
+2K153186Adjustable Fixation DeviceArthrocare Corp.20161—
+2K143092Tensyn PlugDallen Medical, Inc.20151—
+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
+2K123341Arthrex Pec Repair Button, Arthrex Large Pec Button, Arthrex Biceps Button, Arthrex…Arthrex, Inc.201252—
+3K252081SportLinc Syndesmosis DeviceLincotek Medical20260—
+3K251134RipCordTriMed, Inc.20250—
+3K242091Bolo Button SystemFusion Orthopedics20240—
+3K233531OIC FLEX-FIX™ SystemOrthopaedic Implant Company20240—
+3K231857Arthrex TightRope IIArthrex, Inc.20234—
+3K222971ULTRABUTTON QUAD Adjustable Fixation Device; ULTRABUTTON BB Adjustable Fixation Device…Smith & Nephew, Inc.20230—
+3K220650TriMed Ripcord DeviceTriMed, Inc.202211
+3K211770R3ACT Stabilization SystemParagon 28, Inc.20213—
+3K211049Tigon Medical Button SystemTigon Medical20210—
+3K203121Responsive Arthroscopy Thunderbolt SystemResponsive Arthroscopy, LLC20211—
+3K202444Knotless TensionTight Button Implant SystemArthrex, Inc.20201—
+3K200028Coronet Soft Tissue Fixation SystemConextions Medical20202—
+3K191426FiberTak ButtonArthrex, Inc.20190—
+3K190288Arthrex Tenodesis ButtonArthrex, Inc.20194—
+3K190774RIGIDLOOP Titanium Button , RIGIDLOOP Cortical Fixation System XL ImplantMedos International SARL20191—
+3K173278ToggleLoc SystemBiomet, Inc.20183—
+3K170440KISSloc Suture SystemArthrosurface, Inc.20171—
+3K153211M-Fix Acromioclavicular DeviceCoracoid Solutions, Inc.20160—
+3K151004PULLUP® Adjustable Juxtacortical Fixation DeviceSbm Sciences For Bio Materials20152—
+3K150768JuggerKnot Soft AnchorsBiomet Manufacturing Corp201540—
+3K150359Tensyn PlugDallen Medical, Inc.20150—
+3K141263Toggleloc and Juggerloc Implants/Instruments/KitsBiomet Manufacturing Corp201402
+3K141264Tensyn Band, Tensyn Fracture PlatesDallen Medical, Inc.20142—
+3K141219Juggerloc Bone to Bone Implants/ Bone Instruments/ Bone Implant and Instrument KitsBiomet Manufacturing Corp20141—
+4K253065Aevumed SUPERCYNCH™ Button SystemAevumed, Inc.20260—
+4K261632Thunderbolt SystemResponsive Arthroscopy, Inc.20260—
+4K250844PULLUP®; PULLUP® CLIP; BT LOOP®; PULLUP® TEX CLIP; RIGIDLOOP™ T; RIGIDLOOP™ Clip…Science & Bio Materials (S.B.M.) Sas20250—
+4K240035TACTIX Vector Syndesmosis SystemVilex, LLC20241—
+4K240947TENSOR® Suture Button SystemGlobus Medical, Inc.20240—
+4K241235Arthrex TightRope IIArthrex, Inc.20243—
+4K232941Megaloop Button SystemSuzhou Endophix Co., Ltd.20240—
+4K220966SinefixBAAT Medical Products B.V.20231—
+4K223589Grappler Suture Anchor R3FLEX IOL SystemParagon 28, Inc.20232—
+4K220260Hercules Syndesmosis Implant SystemIn2bones USA, LLC20220—
+4K203740JuggerKnot Soft AnchorRiverpoint Medical20215—
+4K203485SnugFit All-Suture AnchorMedacta International S.A.20212—
+4K202193PULLUP BTB Adjustable Fixation System for Ligament Reconstruction, PULLUP CLIP…S.B.M. Sas (Science & Bio Materials)20201—
+4K193461MectaLock All-Suture AnchorsMedacta International S.A.20203—
+4K192750AcTiFlip Naked, AcTiFlip Cinch, AcTiFlip WHIP, GFS Ultimate HipParcus Medical, LLC20203—
+4K190728Arthrex SwiveLock AnchorsArthrex, Inc.20192—
+4K180768Arthrex SwiveLock AnchorsArthrex, Inc.201828—
+4K172620SyndesMetrics Syndesmosis Repair SystemMortise Medical, LLC20170—
+4K153558Ventix Suture AnchorBiomet Manufacturing Corp20160—
+5K254176SinefixBAAT Medical Products B.V.20260—
+5K260405FiberTape ButtonArthrex, Inc.20260—
+5K250867Dunamis Screw and Suture Locking SystemDunamis Medical, LLC20250—
+5K251933SnugFit ASA ExtensionMedacta International S.A.20250—
+5K250424Arthrex TightRope Soft Button, RTArthrex, Inc.20250—
+5K243408TACTIX Vector Syndesmosis SystemVilex, LLC20240—
+5K242494OsseoFit Interfacing Anchor; OsseoFit Bone Tunnel ConstructRiverpoint Medical, LLC20240—
+5K240594Grappler Suture Anchor R3FLEX IOL SystemParagon 28, Inc.20241—
+5K232973Arthrex Knee FiberTak® Button Suture AnchorArthrex, Inc.20234—
+5K232411JuggerKnot Soft Anchor OCRiverpoint Medical, LLC20232—
+5K231128JuggerKnot Soft AnchorRiverpoint Medical, LLC20230—
+5K230544SnugFit All-Suture Anchor extensionMedacta International S.A.20231—
+5K212381VersaTap, VersaLat, DueLock, VersaTi, MiniTiOrtho-Design (Pty), Ltd.20211—
+5K212739ActiFlipParcus Medical, LLC20210—
+5K202259Parcus GFS II and GFS Mini, GFS Naked, GFS Ultimate, GFS BTB, ATLAS, Synd-EZ Ti…Parcus Medical, LLC20202—
+5K192441Arthrex SwiveLock AnchorsArthrex, Inc.20192—
+5K191226Arthrex SwiveLock Suture AnchorArthrex, Inc.201921—
+6K253886Grappler Suture Anchor PCFD Tether SystemParagon 28, Inc.20260—
+6K251309OSSIOfiber® Suture AnchorOSSIO, Ltd.20251—
+6K243203OC JuggerKnotless Soft Anchor; OC JuggerLoop Soft AnchorRiverpoint Medical20240—
+6K242296VersaTap™ Suture Anchor (ADP050); VersaPEEK™ Suture Anchor (APP002); MicroTi™ Suture…Ortho-Design (Pty), Ltd.20240—
+6K240719OC JuggerKnot Soft AnchorRiverpoint Medical20240—
+6K213018Auxilock GFS Mini, GFS II Large, and GFS UltimateAuxein Medical Private Limited20220—
+6K222263Arthrex Self Punching SwiveLock Suture AnchorsArthrex, Inc.20220—
+6K211502Alpha Vent PEEK Suture AnchorStryker Endoscopy20211—
+6K203495Arthrex SwiveLock AnchorArthrex, Inc.2021131
+6K193503Arthrex SwiveLock Suture AnchorArthrex, Inc.20204—
+7K253538TeKBrace Knotless AnchorTheramicro20260—
+7K253695LigaMendRiverpoint Medical, LLC20260—
+7K254055OSSIOfiber® Suture AnchorOSSIO, Ltd.20260—
+7K250528Stryker AlphaVent™ Knotless SP Biocomposite AnchorStryker Endoscopy20250—
+7K243988RootMend MRRRiverpoint Medical, LLC20250—
+7K243712WasherCap™ Mini Fixation System (Model 45)Abanza Tecnomed S.L20251—
+7K233893AlphaVent Knotless SP PEEK AnchorStryker Endoscopy20241—
+7K231093AlphaVent Suture AnchorsStryker Endoscopy20230—
+7K231002Javelot PK-S suture anchor, Javelot PK-S suture anchor (Knotless), Javelot PK-P suture…Suzhou Endophix Co., Ltd.20230—
+7K230435Arthrex 3.9 mm SwiveLock AnchorArthrex, Inc.20231—
+7K213415OSSIOfiber Suture AnchorOSSIO, Ltd.20223—
+8K253618QuadLock™ Fixation SystemAbanza Tecnomed S.L20260—
+8K243760OSSIOfiber® Suture Anchor 2.5-3.5 mmOSSIO, Ltd.20250—