# K250197: Estremo Fibular Nail

- Pathway: 510(k) (Traditional)
- Applicant: Citieffe S.R.L.
- Decided: Oct 17, 2025 after 267 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 K960642 (1996). 24 ancestors in all.
No later device cites it as a predicate yet.
0 of 25 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.
- K192710: The Simple Locking Intramedullary (Slim) System, Pega Medical, Inc. (2020) Summary page 5.

## Indications for use
Estremo Fibular Nail is intended for use in the fixation of fibula fractures and osteotomies.

Source page: https://510kreport.com/device/K250197
Methodology: https://510kreport.com/methodology