| K-number | K260405 |
| Device name | FiberTape Button |
| Applicant | Arthrex, Inc. |
| Product code | MBI |
| Device class | Class II |
| Decision date | Mar 9, 2026 |
| Decision | Substantially Equivalent |
| Regulation | 888.3040 |
The FiberTape Button is a suture-button construct comprised of a titanium button and nonabsorbable suture, provided sterile and single-use. It is intended for fixation of bone to bone or soft tissue to bone, serving as a fixation post, distribution bridge, or for distributing suture tension during ligament and tendon repairs including ACL, PCL, MCL, and other knee ligament and tendon procedures.
The FiberTape Button has identical components to predicate devices Arthrex TightRope II and Arthrex Suture, but assembled in a new configuration. The device consists of a titanium button combined with nonabsorbable suture material. Any differences from predicate devices are considered minor and do not raise new safety or effectiveness questions.
Arthrex utilized test methods aligned with the previously cleared RetroButton (K062747, cleared 09/29/2006), completing straight pull testing to demonstrate ultimate load and cyclic displacement performance. The summary also references verification and validation for MRI compatibility, biocompatibility, packaging, shelf-life, material stability, and sterilization.
The FiberTape Button is substantially equivalent to predicates Arthrex TightRope II and Arthrex Suture because it uses identical components assembled in a new configuration with the same intended use for soft tissue and bone fixation. Any minor differences do not result in new or different questions concerning safety or effectiveness, and the device meets the same performance criteria as the cleared predicates.
View the full FDA submission: accessdata.fda.gov