# K111352: Talon Distalfix Proximal Femoral Nail

- Pathway: 510(k) (Abbreviated)
- Applicant: Orthopedic Designs North America, Inc.
- Decided: Aug 22, 2011 after 101 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 K850886 (1985). 26 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 28 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K043431: GAMMA3 Nail System, Howmedica Osteonics Corp. (2005) Summary page 2.
- K034002: GAMMA3 Nail System, Howmedica Osteonics Corp. (2004) Summary page 2.
- K032244: Gamma 3 Nail System, Howmedica Osteonics Corp. (2003) Summary page 2.
- K014189: Odi Talon Intramedullary Hip Nail, Orthopedic Designs, Inc. (2002) Summary page 2.
- K033286: Odi Talon Long Proximal Femoral Nail System, Orthopedic Designs, Inc. (Odi) (2004) Summary page 2.

## Most influential descendants
- K223933: Exactech Equinoxe PHx Fracture System; Exactech EPIC Screws (2023), 0 descendants of its own

## Indications for use
The Talon Tm DistalFixrM Proximal Femoral Nail's primary indications are for fixation/stabilization of stable and unstable fractures of the proximal femur including intertrochanteric fractures, pertrochanteric fractures, high subtrochanteric fractures (without shaft extension), and combinations of these fractures. The long nail allows the additional indication of low subtrochanteric fractures. The device is intended to stabilize fragments of the fracture until bony union can occur.

Source page: https://510kreport.com/device/K111352
Methodology: https://510kreport.com/methodology