# K232648: RODEO Telescopic Nail

- Pathway: 510(k) (Traditional)
- Applicant: Orthofix Srl
- Decided: May 3, 2024 after 246 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: 5 generations back to K960642 (1996). 7 ancestors in all.
No later device cites it as a predicate yet.
0 of 8 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K211292: Fassier-Duval Telescopic IM System, Pega Medical, Inc. (2021) Summary page 4.

## Indications for use
The RODEO Telescopic Nail is indicated for fractures, osteotomies, malunions and non-unions in femur and tibia in pediatric patients suffering from osteogenesis imperfecta.

Source page: https://510kreport.com/device/K232648
Methodology: https://510kreport.com/methodology