Arthrex, Inc. · Class II · Cleared Mar 2, 2026
| K-number | K254229 |
| Device name | Arthrex Nano FiberTak Suture Anchor |
| Applicant | Arthrex, Inc. |
| Product code | MBI |
| Device class | Class II |
| Decision date | Mar 2, 2026 |
| Decision | Substantially Equivalent |
| Regulation | 888.3040 |
The Arthrex Nano FiberTak Suture Anchor is an all-suture soft-tissue fixation device made from ultra-high molecular weight polyethylene and polyester, designed with a push-in mechanism preloaded on an inserter with needles. It is intended for soft tissue to bone fixation in hand and wrist applications, including ligament reconstruction and tendon repair at various finger joints.
The Nano FiberTak Suture Anchor shares similar technology with the primary predicate JuggerKnot Mini Soft Anchor, featuring an all-suture design with push-in deployment. Differences between the Nano FiberTak and predicate devices are considered minor and do not raise new safety or effectiveness concerns.
Cyclic displacement testing was conducted in accordance with ASTM F3690-24. Static pull testing was also performed comparing the proposed device to the primary predicate.
The Nano FiberTak Suture Anchor is substantially equivalent to the JuggerKnot Mini Soft Anchor predicate because both devices share the same basic design features, intended use for soft tissue to bone fixation, and any differences are minor. The submitted performance data and technological characteristics demonstrate no new or different questions concerning safety and effectiveness.
View the full FDA submission: accessdata.fda.gov