# K260405: FiberTape Button

- Pathway: 510(k) (Special)
- Applicant: Arthrex, Inc.
- Decided: Mar 9, 2026 after 28 days
- Product code: MBI (Fastener, Fixation, Nondegradable, Soft Tissue)
- Device class: 2
- Regulation: 21 CFR 888.3040
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 16 generations back to K961555 (1996). 131 ancestors in all.
No later device cites it as a predicate yet.
0 of 132 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K241235: Arthrex TightRope II, Arthrex, Inc. (2024) Summary page 5.
- K122374: Arthrex Suture (Uhmwpe), Arthrex, Inc. (2012) Summary page 5.
- K203495: Arthrex SwiveLock Anchor, Arthrex, Inc. (2021) Summary page 5.

## Indications for use
The FiberTape Button is intended to be used for fixation of bone to bone or soft tissue to bone and is intended as a fixation post, a distribution bridge, or for distributing suture tension over areas of ligament or tendon repair. Specifically, Arthrex will be offering the FiberTape Button for primary or secondary fixation for ACL, PCL, MCL, POL, LCL, MPFL, ALL, PLC, Quadriceps Tendon, and Patellar Tendon repair and reconstruction and Iliotibial Band tenodesis.

Source page: https://510kreport.com/device/K260405
Methodology: https://510kreport.com/methodology