# K042440: Alphatec Femoral Trochanteric Nail (FTN) System

- Pathway: 510(k) (Traditional)
- Applicant: Alphatec/Nexmed
- Decided: Oct 7, 2004 after 28 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: 4 generations back to K970097 (1997). 13 ancestors in all.
No later device cites it as a predicate yet.
0 of 14 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K010780: Trochanteric Nail, DePuy Orthopaedics, Inc. (2001) Summary page 1.
- K021008: Advanced Orthopaedic Solutions Trochanteric Nail, Advanced Orthopaedic Solutions, Inc. (2002) Summary page 1.
- K013524: Trochanteric Dyax Nail System, Howmedica Osteonics Corp. (2001) Summary page 1.

## Indications for use
The Alphatec Femoral Trochanteric Nail (FTN) System is intended to treat stable and unstable proximal fractures of the femur including pertrochanteric fractures, intertrochanteric fractures, high subtrochanteric fractures and combinations of these fractures.

Source page: https://510kreport.com/device/K042440
Methodology: https://510kreport.com/methodology