# K152295: Talon DistalFix Antegrade/Retrograde Femoral Nail

- Pathway: 510(k) (Traditional)
- Applicant: Orthopedic Designs North America, Inc.
- Decided: Nov 3, 2015 after 82 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 K010801 (2001). 5 ancestors in all.
No later device cites it as a predicate yet.
0 of 6 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K112059: T2 Femoral Nail Model 1825-Xxxxcp, 1828-Xxxxcp, Stryker (2011) Summary page 5.
- K081152: T2 Femoral Nail, Howmedica Osteonics Corp. (2008) Summary page 5.
- K021744: T2 Femoral Nail, Howmedica Osteonics Corp. (2002) Summary page 5.

## Indications for use
The Talon™ DistalFix™ Antegrade/Retrograde Femoral Nail’s primary indications are for fixation/stabilization of stable and unstable fractures of the femur including: * Femoral shaft fractures * Ipsilateral femur fractures * Supracondylar fractures, including those with intra-articular extension * Osteoporotic fractures » Pathologic/impending pathologic fractures » Malunions/nonunions The device is intended to stabilize fragments of the fracture until bony union can occur.

Source page: https://510kreport.com/device/K152295
Methodology: https://510kreport.com/methodology