# K252196: Arthrex FibuLock Nail System

- Pathway: 510(k) (Traditional)
- Applicant: Arthrex, Inc.
- Decided: Mar 5, 2026 after 234 days
- Product code: HSB (Rod, Fixation, Intramedullary And Accessories)
- Device class: 2
- Regulation: 21 CFR 888.3020
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 7 generations back to K792022 (1979). 45 ancestors in all.
No later device cites it as a predicate yet.
0 of 46 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K173656: Arthrex FibuLock Nail, Arthrex, Inc. (2018) Summary page 5.
- K160069: Sonoma Fibula Repair System, Sonoma Orthopedics Products, Inc. (2016) Summary page 5.
- K201522: Arthrex Syndesmosis TightRope XP Buttress Plate Implant System, Arthrex, Inc. (2020) Summary page 5.

## Indications for use
The Arthrex FibuLock Nail System is intended for use in the fixation of fibula fractures and osteotomies. The Buttress Plate is intended for use with the FibuLock PRO Nail and Arthrex TightRope Syndesmosis Devices to support additional stabilization for fibula fractures. The Buttress Plate is designed for use with the FibuLock PRO Nail and TightRope Syndesmosis devices and may not be used as a stand-alone device.

Source page: https://510kreport.com/device/K252196
Methodology: https://510kreport.com/methodology