# K252961: Fusion FibFix Nail

- Pathway: 510(k) (Traditional)
- Applicant: Fusion Orthopedics USA, LLC
- Decided: Mar 18, 2026 after 183 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: 11 generations back to K962823 (1996). 60 ancestors in all.
No later device cites it as a predicate yet.
0 of 61 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K212030: Flex-Thread™ Distal Fibula lntramedullary Nail System, Flower Orthopedics Corporation Dba Conventus Flower (2021) Summary page 5.
- K031438: Acumed Small Bone Locking Rod System II, Acumed, LLC (2003) Summary page 5.

## Indications for use
The Fusion FibFix Nail is intended for use in the fixation of fibula fractures and osteotomies.

Source page: https://510kreport.com/device/K252961
Methodology: https://510kreport.com/methodology