# K232169: FITBONE® Transport and Lengthening System

- Pathway: 510(k) (Traditional)
- Applicant: Orthofix Srl
- Decided: Mar 22, 2024 after 245 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: 9 generations back to K831576 (1983). 19 ancestors in all.
2 later devices descend from it; 2 cite it directly.
0 of 22 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K201567: Precice® Bone Transport System, Nuvasive Specialized Orthopedics, Inc. (2020) Summary page 4.
- K203399: Fitbone (R) Taa, Wittenstein Intens GmbH (2021) Summary page 4.

## Most influential descendants
- K260146: Fitbone® Transport and Lengthening System (2026), 0 descendants of its own
- K253991: Fitbone™ Trochanteric,  FITBONE® Transport and Lengthening System,  FITBONE® TAA (2026), 0 descendants of its own

## 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/K232169
Methodology: https://510kreport.com/methodology