# K253991: Fitbone™ Trochanteric,  FITBONE® Transport and Lengthening System,  FITBONE® TAA

- Pathway: 510(k) (Traditional)
- Applicant: Orthofix Srl
- Decided: May 8, 2026 after 147 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). 21 ancestors in all.
No later device cites it as a predicate yet.
0 of 22 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.
- K203399: Fitbone (R) Taa, Wittenstein Intens GmbH (2021) Summary page 5.
- K232169: FITBONE® Transport and Lengthening System, Orthofix Srl (2024) Summary page 5.

## Indications for use
Fitbone™ Trochanteric is indicated for limb lengthening of the femur.Fitbone Trochanteric is indicated for adult and pediatric (greater than 12 through 21 years of age) patients. FITBONE® TAA is an intramedullary lengthening system for limb lengthening of the femur and tibia. The FITBONE®TAA intramedullary lengthening system is indicated for adult and pediatric (greater than 12 through 21 years of age) patients. The 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/K253991
Methodology: https://510kreport.com/methodology