# K142052: Orthofix Galaxy Unyco Diaphyseal Tibia Kit

- Pathway: 510(k) (Traditional)
- Applicant: Orthofix Srl
- Decided: Dec 5, 2014 after 130 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: 3 generations back to K831576 (1983). 12 ancestors in all.
2 later devices descend 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.
- K113770: Orthofix Galaxy Fixation System, Orthofix Srl (2012) Summary page 4.
- K122284: Hoffmann 3, Stryker Corp. (2012) Summary page 4.

## Most influential descendants
- K153233: Galaxy UNYCO System (2016), 1 descendant of its own
- 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 Diaphyseal Tibia Kit is intended to be used to provide treatment for bone stabilization in trauma, specifically lower limb fractures that require temporary fixation prior to definitive fixation. The Galaxy UNYCO Diaphyseal Tibia Kit is indicated to be used for temporary stabilization of tibial fractures in trauma procedures (damage control orthopaedics prior to definitive treatment). The product is indicated for non-weight-bearing use. The indications for use include: • Tibial fractures extending from about 8cm below the knee to about 7 cm above the ankle joint, including comminuted open or closed tibial fractures and polytrauma. • Temporary stabilisation of the tibia after debridement for osteomyelitis or an infected non-union pending second stage treatment.

Source page: https://510kreport.com/device/K142052
Methodology: https://510kreport.com/methodology