# K170146: Galaxy UNYCO System

- Pathway: 510(k) (Traditional)
- Applicant: Orthofix Srl
- Decided: Oct 12, 2017 after 268 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: 5 generations back to K831576 (1983). 14 ancestors in all.
No later device cites it as a predicate yet.
0 of 15 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K082650: Synthes Large External Fixation, MR Conditional, Synthes (Usa) (2008) Summary page 4.
- K153233: Galaxy UNYCO System, Orthofix Srl (2016) Summary page 4.

## Indications for use
The Galaxy UNYCO System is intended to be used for temporary bone stabilization in trauma and orthopedic procedures of the lower limb prior to definitive treatment. Temporary stabilization of the femur, tibia and ankle in conditions and procedures, such as: • comminuted open or closed fractures • polytrauma patient • damage control orthopedics for fractures with severe soft tissue injuries • peri-prosthetic or peri-implant fractures • joint dislocations, intra- and extra-articular injuries where spanning fixation is needed • intra-operative fracture reduction • intermediate stabilization in staged surgery • infected non-union pending second stage treatment bone-loss or other reconstructive procedures.

Source page: https://510kreport.com/device/K170146
Methodology: https://510kreport.com/methodology