# K260018: Arthrex FiberButton

- Pathway: 510(k) (Traditional)
- Applicant: Arthrex, Inc.
- Decided: Jun 26, 2026 after 172 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: 10 generations back to K904436 (1990). 53 ancestors in all.
No later device cites it as a predicate yet.
0 of 54 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K193157: Arthrex 3.9mm Corkscrew Suture Anchor, Arthrex, Inc. (2019) Summary page 5.
- K101823: Arthrex Swivelock Anchors, Arthrex, Inc. (2011) Summary page 5.
- K122374: Arthrex Suture (Uhmwpe), Arthrex, Inc. (2012) Summary page 5.
- K193575: Arthrex SutureTape, Arthrex, Inc. (2020) Summary page 5.
- K171296: SutureTape, Arthrex, Inc. (2017) Summary page 5.
- K170206: Arthrex FiberTape Cerclage, Arthrex, Inc. (2017) Summary page 5.

## Indications for use
The Arthrex FiberButton is intended for use with Arthrex Suture Anchors and/or Arthrex Suture for orthopedic use. The Arthrex FiberButton is not intended for stand-alone use, and is intended to be used in accordance with the cleared Indications for Use for the Arthrex Suture Anchors (8 mm and smaller) and Arthrex Sutures (FiberWire: sizes #4-0, #3-0, #2-0, #1-0, #0, #1, #2, #3, #4, and #5; FiberTape: sizes 2.2 and 1.7 mm; SutureTape: sizes 0.9, 1.7 and 1.3 mm; materials: UHMWPE, polyester and nylon) for orthopedic use.

Source page: https://510kreport.com/device/K260018
Methodology: https://510kreport.com/methodology