# K150579: Cardinal Health External Fixation System

- Pathway: 510(k) (Traditional)
- Applicant: Cardinalhealth
- Decided: Apr 29, 2015 after 51 days
- Product code: KTT (Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component)
- Device class: 2
- Regulation: 21 CFR 888.3030
- 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 K082650 (2008). 2 ancestors in all.
No later device cites it as a predicate yet.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K140675: Emerge External Fixation System, Emerge Medical, Inc. (2014) Summary page 5.

## Indications for use
The Cardinal Health External Fixation System is intended for use to provide treatment for long bone and pelvic fractures that require external fixation. The system can be used for: • Stabilization of soft tissues and fractures • Polytrauma/multiple orthopedic trauma • Vertically stable pelvic fractures, or as a treatment adjunct for vertically unstable pelvic fractures • Arthrodeses and osteotomies with soft tissue problems; failures of total joints • Neutralization of fractures stabilized with limited internal fixation • Non-unions/septic non-unions • Intra-operative reductions/stabilization tool to assist with indirect reduction • Unilateral rectilinear bone segment transport or leg lengthening

Source page: https://510kreport.com/device/K150579
Methodology: https://510kreport.com/methodology