# K141760: Orthofix Galaxy Wrist

- Pathway: 510(k) (Traditional)
- Applicant: Orthofix Srl
- Decided: Dec 8, 2014 after 160 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.
No later device cites it as a predicate yet.
0 of 13 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K963618: Synthes Simple Small External Fixator (Ssef), Synthes (Usa) (1996) Summary page 4.
- K053038: Hoffmann II Compact Mri External Fixation System, Howmedica Osteonics Corp. (2005) Summary page 4.
- K955848: Orthofix Modulsystem, Orthofix, Inc. (1996) Summary page 4.
- K113770: Orthofix Galaxy Fixation System, Orthofix Srl (2012) Summary page 4.

## Recalls of this device
- Sep 27, 2018 · Class II · Z-0403-2020: As a result of complaint investigations it was determined that batches of drill bits have a geometrical detail that does not correspond to the intended design. This could result in lower cutting perfo

## Indications for use
The Orthofix Galaxy Wrist external fixator is an orthopedic device intended to be used for bone stabilization in trauma and orthopedic procedures, both on adults and pediatric patients as required. The indications for use include: - intra-articular or extra-articular fractures and dislocations of the wrist with or without soft tissue damage: - polytrauma; - carpal dislocations; - unreduced fractures following conservative treatment; - bone-loss or other reconstructive procedures; - infection.

Source page: https://510kreport.com/device/K141760
Methodology: https://510kreport.com/methodology