510(k) Report

Devices descending from K130033

35 later devices reach Toggleloc Xtender; Toggleloc XL; Implant Kit Toggleloc; Implant Kit Toggleloc… through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K252081SportLinc Syndesmosis DeviceLincotek Medical20260—
+1K251134RipCordTriMed, Inc.20250—
+1K242091Bolo Button SystemFusion Orthopedics20240—
+1K233531OIC FLEX-FIX™ SystemOrthopaedic Implant Company20240—
+1K231857Arthrex TightRope IIArthrex, Inc.20234—
+1K220650TriMed Ripcord DeviceTriMed, Inc.202211
+1K211770R3ACT Stabilization SystemParagon 28, Inc.20213—
+1K203121Responsive Arthroscopy Thunderbolt SystemResponsive Arthroscopy, LLC20211—
+1K200028Coronet Soft Tissue Fixation SystemConextions Medical20202—
+1K173278ToggleLoc SystemBiomet, Inc.20183—
+1K170440KISSloc Suture SystemArthrosurface, Inc.20171—
+1K153186Adjustable Fixation DeviceArthrocare Corp.20161—
+1K151004PULLUP® Adjustable Juxtacortical Fixation DeviceSbm Sciences For Bio Materials20152—
+1K141263Toggleloc and Juggerloc Implants/Instruments/KitsBiomet Manufacturing Corp201402
+1K141219Juggerloc Bone to Bone Implants/ Bone Instruments/ Bone Implant and Instrument KitsBiomet Manufacturing Corp20141—
+1K140324Rigidloop Adjustable Cortical Implant: Standard, Long and XLDepuy Mitek, A Johnson and Johnson Company20140—
+1K133606N8TIVE Acl Anatomic Reconstruction System, N8TIVE Acl Femoral Implant, N8TIVE Acl Tibial…ArthroCare Corporation20142—
+2K261632Thunderbolt SystemResponsive Arthroscopy, Inc.20260—
+2K250844PULLUP®; PULLUP® CLIP; BT LOOP®; PULLUP® TEX CLIP; RIGIDLOOP™ T; RIGIDLOOP™ Clip…Science & Bio Materials (S.B.M.) Sas20250—
+2K240035TACTIX Vector Syndesmosis SystemVilex, LLC20241—
+2K240947TENSOR® Suture Button SystemGlobus Medical, Inc.20240—
+2K241235Arthrex TightRope IIArthrex, Inc.20243—
+2K220966SinefixBAAT Medical Products B.V.20231—
+2K223589Grappler Suture Anchor R3FLEX IOL SystemParagon 28, Inc.20232—
+2K222971ULTRABUTTON QUAD Adjustable Fixation Device; ULTRABUTTON BB Adjustable Fixation Device…Smith & Nephew, Inc.20230—
+2K220260Hercules Syndesmosis Implant SystemIn2bones USA, LLC20220—
+2K202193PULLUP BTB Adjustable Fixation System for Ligament Reconstruction, PULLUP CLIP…S.B.M. Sas (Science & Bio Materials)20201—
+2K172620SyndesMetrics Syndesmosis Repair SystemMortise Medical, LLC20170—
+3K254176SinefixBAAT Medical Products B.V.20260—
+3K260405FiberTape ButtonArthrex, Inc.20260—
+3K250867Dunamis Screw and Suture Locking SystemDunamis Medical, LLC20250—
+3K250424Arthrex TightRope Soft Button, RTArthrex, Inc.20250—
+3K243408TACTIX Vector Syndesmosis SystemVilex, LLC20240—
+3K240594Grappler Suture Anchor R3FLEX IOL SystemParagon 28, Inc.20241—
+4K253886Grappler Suture Anchor PCFD Tether SystemParagon 28, Inc.20260—