# K150769: Cardinal Health Trochanteric IM Nail System

- Pathway: 510(k) (Traditional)
- Applicant: Cardinalhealth
- Decided: Dec 14, 2015 after 265 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)
- K034002: GAMMA3 Nail System, Howmedica Osteonics Corp. (2004) Summary page 5.

## Indications for use
The Cardinal Health Trochanteric IM Nail System is intended to provide temporary fixation of the femur for various types of open or closed fractures including malunions, nonunions (pseudoarthrosis), pathologic fractures, and impending pathologic fractures. Fracture types include pertrochanteric fractures, intertrochanteric fractures, basal neck fractures. Long Length Nails: Fracture types include pertrochanteric fractures, subtrochanteric fractures, intertrochanteric fractures, femoral shaft fractures, and basilar neck fractures.

Source page: https://510kreport.com/device/K150769
Methodology: https://510kreport.com/methodology