# K250112: FitboneTM Trochanteric

- Pathway: 510(k) (Traditional)
- Applicant: Orthofix Srl
- Decided: Apr 10, 2025 after 84 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). 13 ancestors in all.
No later device cites it as a predicate yet.
0 of 14 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K233867: Fitbone Trochanteric, Orthofix Srl (2024) Summary page 5.

## Indications for use
FitboneTM Trochanteric is indicated for limb lengthening of the femur. FitboneTM Trochanteric is indicated for adult and pediatric (greater than 12 through 21 years of age) patients.

Source page: https://510kreport.com/device/K250112
Methodology: https://510kreport.com/methodology