Arthrex, Inc. · Class II · Cleared Mar 11, 2025
| K-number | K250424 |
| Device name | Arthrex TightRope Soft Button, RT |
| Applicant | Arthrex, Inc. |
| Product code | MBI |
| Device class | Class II |
| Decision date | Mar 11, 2025 |
| Decision | Substantially Equivalent |
| Regulation | 888.3040 |
The Arthrex TightRope Soft Button, RT is a bone fixation device comprising a suture loop, suture button, and passing sutures made of braided nonabsorbable surgical sutures. It is intended for fixation of bone-to-bone or soft tissue-to-bone in various ligament and tendon repairs including ACL/PCL, MCL, LCL, and other knee ligament reconstructions in adult patients.
The device has similar technological characteristics to its predicate devices. The primary difference is that the proposed Arthrex TightRope Soft Button, RT uses an all-suture radiopaque button rather than a titanium button. The suture material itself is identical to that used in the predicate and reference devices.
Not stated in this summary.
Cyclic pull-out testing demonstrated that the proposed device is equivalent in performance to the primary predicate device (Arthrex ACL TightRope RC). The suture composition is identical to legally marketed predicate devices, and the only meaningful difference is the button material (suture-based radiopaque versus titanium), which does not raise new questions about safety or effectiveness given the same intended use and similar functionality.
View the full FDA submission: accessdata.fda.gov