510(k) Report

Devices descending from K112990

49 later devices reach Acl Tightrope,Acl Tightrope Duuble Bundle through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K250424Arthrex TightRope Soft Button, RTArthrex, Inc.20250—
+1K232941Megaloop Button SystemSuzhou Endophix Co., Ltd.20240—
+1K221128Arthrex ACL TightRope®, PCL TightRope®, and TightRope® IIArthrex, Inc.20226—
+1K220906Secure-LockXiros, Ltd.20220—
+1K203259FairFix Adjustable Button SystemMedacta International S.A.20213—
+1K202581Arthrex TightRope IIArthrex, Inc.20209—
+1K191319Dunamis Fixation Button SystemDunamis, LLC20191—
+1K151004PULLUP® Adjustable Juxtacortical Fixation DeviceSbm Sciences For Bio Materials20152—
+1K150416ProCinch Adjustable Loop DeviceStryker Endoscopy20151—
+1K130033Toggleloc Xtender; Toggleloc XL; Implant Kit Toggleloc; Implant Kit Toggleloc BTB…Biomet Manufacturing Corp2013353
+2K252081SportLinc Syndesmosis DeviceLincotek Medical20260—
+2K253693Strut Suture; No-Tie ButtonRiverpoint Medical, LLC20260—
+2K250867Dunamis Screw and Suture Locking SystemDunamis Medical, LLC20250—
+2K251134RipCordTriMed, Inc.20250—
+2K250844PULLUP®; PULLUP® CLIP; BT LOOP®; PULLUP® TEX CLIP; RIGIDLOOP™ T; RIGIDLOOP™ Clip…Science & Bio Materials (S.B.M.) Sas20250—
+2K242091Bolo Button SystemFusion Orthopedics20240—
+2K233531OIC FLEX-FIX™ SystemOrthopaedic Implant Company20240—
+2K231857Arthrex TightRope IIArthrex, Inc.20234—
+2K231404T-Button® A Adjustable Loop UHMWPE Suture PEEK Button, Close Button, T-Button® S…Healthium Medtech Limited20230—
+2K223795FairFix QT Adjustable ButtonMedacta International S.A.20230—
+2K222169FairFix Adjustable Button SystemMedacta International S.A.20220—
+2K221389FairFix AM Adjustable Button FairFix PSP Adjustable ButtonMedacta International S.A.20220—
+2K220650TriMed Ripcord DeviceTriMed, Inc.202211
+2K211770R3ACT Stabilization SystemParagon 28, Inc.20213—
+2K203121Responsive Arthroscopy Thunderbolt SystemResponsive Arthroscopy, LLC20211—
+2K210078Stryker ProCinch Adjustable Loop DeviceStryker Endoscopy20210—
+2K202193PULLUP BTB Adjustable Fixation System for Ligament Reconstruction, PULLUP CLIP…S.B.M. Sas (Science & Bio Materials)20201—
+2K200028Coronet Soft Tissue Fixation SystemConextions Medical20202—
+2K173278ToggleLoc SystemBiomet, Inc.20183—
+2K170440KISSloc Suture SystemArthrosurface, Inc.20171—
+2K153186Adjustable Fixation DeviceArthrocare Corp.20161—
+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—
+3K261632Thunderbolt SystemResponsive Arthroscopy, Inc.20260—
+3K240035TACTIX Vector Syndesmosis SystemVilex, LLC20241—
+3K240947TENSOR® Suture Button SystemGlobus Medical, Inc.20240—
+3K241235Arthrex TightRope IIArthrex, Inc.20243—
+3K220966SinefixBAAT Medical Products B.V.20231—
+3K223589Grappler Suture Anchor R3FLEX IOL SystemParagon 28, Inc.20232—
+3K222971ULTRABUTTON QUAD Adjustable Fixation Device; ULTRABUTTON BB Adjustable Fixation Device…Smith & Nephew, Inc.20230—
+3K220260Hercules Syndesmosis Implant SystemIn2bones USA, LLC20220—
+3K172620SyndesMetrics Syndesmosis Repair SystemMortise Medical, LLC20170—
+4K254176SinefixBAAT Medical Products B.V.20260—
+4K260405FiberTape ButtonArthrex, Inc.20260—
+4K243408TACTIX Vector Syndesmosis SystemVilex, LLC20240—
+4K240594Grappler Suture Anchor R3FLEX IOL SystemParagon 28, Inc.20241—
+5K253886Grappler Suture Anchor PCFD Tether SystemParagon 28, Inc.20260—