# K242091: Bolo Button System

- Pathway: 510(k) (Traditional)
- Applicant: Fusion Orthopedics
- Decided: Dec 23, 2024 after 159 days
- Product code: HTN (Washer, Bolt Nut)
- Device class: 2
- Regulation: 21 CFR 888.3030
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 9 generations back to K904436 (1990). 63 ancestors in all.
No later device cites it as a predicate yet.
0 of 64 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K162996: INVISIKNOT Ankle Syndesmosis Repair Kit, Smith & Nephew, Inc. (2017) Summary page 5.
- K202581: Arthrex TightRope II, Arthrex, Inc. (2020) Summary page 5.
- K130033: Toggleloc Xtender; Toggleloc XL; Implant Kit Toggleloc; Implant Kit Toggleloc BTB, Extended Toggleloc; Toggleloc; BTB to, Biomet Manufacturing Corp (2013) Summary page 5.

## Indications for use
The Bolo Button System is intended to provide fixation as an adjunct to fracture repair hardware during the healing period following an ankle syndesmotic trauma with fracture.

Source page: https://510kreport.com/device/K242091
Methodology: https://510kreport.com/methodology