# K033286: Odi Talon Long Proximal Femoral Nail System

- Pathway: 510(k) (Traditional)
- Applicant: Orthopedic Designs, Inc. (Odi)
- Decided: Jan 12, 2004 after 90 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: 3 generations back to K850886 (1985). 21 ancestors in all.
2 later devices descend from it; 1 cites it directly.
0 of 24 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K895241: Intramedullary Hip Screw, Richards Medical Co., Inc. (1990) Summary page 3.
- K912162: Intramedullary Hip Screw, Modification, Smith & Nephew Richards, Inc. (1991) Summary page 3.
- K921786: Intramedullary Hip Screw, Smith & Nephew Richards, Inc. (1992) Summary page 3.
- K954712: Intramedullary Hip Screw (Modification), Smith & Nephew Richards, Inc. (1995) Summary page 3.
- K893639: Gamma Locking Nail, Howmedica Corp. (1989) Summary page 3.
- K972813: Gamma Locking Nail System, Howmedica Corp. (1997) Summary page 3.
- K944883: Gamma Locking Nail  - Long Length, Howmedica Corp. (1994) Summary page 3.
- K014189: Odi Talon Intramedullary Hip Nail, Orthopedic Designs, Inc. (2002) Summary page 3.
- K984331: Odi Ultimate Compression Hip Screw, Orthopedic Designs, Inc. (1999) Summary page 2.

## Most influential descendants
- K111352: Talon Distalfix Proximal Femoral Nail (2011), 1 descendant of its own
- K223933: Exactech Equinoxe PHx Fracture System; Exactech EPIC Screws (2023), 0 descendants of its own

## Indications for use
The ODi TALON TM Long Proximal Femoral Nail's primary indications are for fixation/stabilization of stable and unstable fractures of the proximal femur including intertrochanteric fractures, pertrochanteric fractures, subtrochanteric fractures, and combinations of these fractures. The device is intended to stabilize fragments of the fracture until bony union can occur.

Source page: https://510kreport.com/device/K033286
Methodology: https://510kreport.com/methodology