# K153233: Galaxy UNYCO System

- Pathway: 510(k) (Traditional)
- Applicant: Orthofix Srl
- Decided: Jan 6, 2016 after 58 days
- Product code: KTT (Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component)
- Device class: 2
- Regulation: 21 CFR 888.3030
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 4 generations back to K831576 (1983). 13 ancestors in all.
1 later device descends from it; 1 cites it directly.
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.
- K142052: Orthofix Galaxy Unyco Diaphyseal Tibia Kit, Orthofix Srl (2014) Summary page 4.

## Most influential descendants
- K170146: Galaxy UNYCO System (2017), 0 descendants of its own

## Recalls of this device
- Jul 5, 2017 · Class II · Z-0291-2018: The power drill torque limiter may break during use in surgery application.

## 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 tibia and foot in conditions and procedures, such as: • comminuted open or closed tibial 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 The Galaxy UNYCO System is compatible with Galaxy Fixation System and bicortical screws. Galaxy Fixation System and bicortical screws must be used when Galaxy UNYCO is not indicated or available. The product is indicated for non-weight-bearing use.

Source page: https://510kreport.com/device/K153233
Methodology: https://510kreport.com/methodology