# K183666: EBA One Nailing System

- Pathway: 510(k) (Traditional)
- Applicant: Citieffe S.R.L.
- Decided: Nov 14, 2019 after 322 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
No predicates in its family tree.
No later device cites it as a predicate yet.
0 of 1 device in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA’s file for it is a 510(k) statement, which names no predicate.

## Indications for use
EBA One Nailing System standard trochanteric nail is indicated for the treatment of stable and unstable intertrochanteric fractures, pertrochanteric fractures, non-unions, mal-unions. EBA One Nailing System long trochanteric nail is indicated for the treatment of pertrochanteric and subtrochanteric fractures with extension of the fracture line to the diaphysis,pertrochanteric and subtrochanteric fractures associated with diaphyseal fractures (bifocal fractures), pathological fractures, non-unions, mal-unions.

Source page: https://510kreport.com/device/K183666
Methodology: https://510kreport.com/methodology