# K233867: Fitbone Trochanteric

- Pathway: 510(k) (Traditional)
- Applicant: Orthofix Srl
- Decided: Jun 18, 2024 after 195 days
- Product code: HSB (Rod, Fixation, Intramedullary And Accessories)
- Device class: 2
- Regulation: 21 CFR 888.3020
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 9 generations back to K831576 (1983). 12 ancestors in all.
2 later devices descend from it; 2 cite it directly.
0 of 15 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K203399: Fitbone (R) Taa, Wittenstein Intens GmbH (2021) Summary page 4.

## Most influential descendants
- K253991: Fitbone™ Trochanteric,  FITBONE® Transport and Lengthening System,  FITBONE® TAA (2026), 0 descendants of its own
- K250112: FitboneTM Trochanteric (2025), 0 descendants of its own

## Recalls of this device
- Sep 24, 2024 · Class II · Z-1977-2025: Retrospective; Their is the potential that implantable intramedullary lengthening nails may bend at the distal tail during insertion resulting in having to be replaced.

## 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.

Source page: https://510kreport.com/device/K233867
Methodology: https://510kreport.com/methodology