# K201147: Elos® Intramedullary Nailing System

- Pathway: 510(k) (Traditional)
- Applicant: Intrauma S.P.A
- Decided: Jul 19, 2021 after 446 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: 2 generations back to K013468 (2001). 3 ancestors in all.
No later device cites it as a predicate yet.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K032244: Gamma 3 Nail System, Howmedica Osteonics Corp. (2003) Summary page 4.
- K034002: GAMMA3 Nail System, Howmedica Osteonics Corp. (2004) Summary page 4.

## Indications for use
The short length Elos nails are intended for stabilizing various types of intertrochanteric fractures of the femur. The long length Elos nails are intended for fixation of femoral fractures occurring from the base of the femoral neck extending distally to a point approximately 10 cm proximal to the intercondylar notch. Fracture types include basilar neck, intertrochanteric, subtrochanteric fractures and femoral shaft fractures. These femoral fractures may occur as a result of trauma, non-union, malunion, pathological fractures, and impending pathological fractures.

Source page: https://510kreport.com/device/K201147
Methodology: https://510kreport.com/methodology