# K260146: Fitbone® Transport and Lengthening System

- Pathway: 510(k) (Traditional)
- Applicant: Orthofix Srl
- Decided: May 19, 2026 after 119 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: 10 generations back to K831576 (1983). 20 ancestors in all.
No later device cites it as a predicate yet.
0 of 21 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K232169: FITBONE® Transport and Lengthening System, Orthofix Srl (2024) Summary page 5.

## Indications for use
Fitbone Transport and Lengthening System is indicated for limb lengthening, open and closed fracture fixation, pseudoarthrosis, malunions, non-unions, or bone transport of the long bones. The Fitbone Transport and Lengthening System is indicated for adult only.

Source page: https://510kreport.com/device/K260146
Methodology: https://510kreport.com/methodology