# K113770: Orthofix Galaxy Fixation System

- Pathway: 510(k) (Traditional)
- Applicant: Orthofix Srl
- Decided: Sep 4, 2012 after 257 days
- Product code: KTT (Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component)
- Device class: 2
- Regulation: 21 CFR 888.3030
- Recalls of this device: 13 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 2 generations back to K831576 (1983). 10 ancestors in all.
6 later devices descend from it; 4 cite it directly.
0 of 17 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 1.
- K090658: Synthes External Fixation Devices, MR Conditional, Synthes (Usa) (2010) Summary page 1.
- K955848: Orthofix Modulsystem, Orthofix, Inc. (1996) Summary page 1.
- K944092: Additional Accessories for the Orthofix System, Orthofix Srl (1995) Summary page 1.
- K072212: Jet-X Bar System Clamps, Bars and Posts-MR Safe, Smith & Nephew, Inc. (2008) Summary page 1.
- K111786: Hoffmann 3 Modular External Fixation System, Stryker Corp. (2012). Cleared while this submission was under review Summary page 3.

## Most influential descendants
- K142052: Orthofix Galaxy Unyco Diaphyseal Tibia Kit (2014), 2 descendants of its own
- K153233: Galaxy UNYCO System (2016), 1 descendant of its own
- K242452: Monkey Bars Pin to Bar External Fixation System (2024), 0 descendants of its own
- K200491: Bfix Orthopedic External Fixator Systems (2021), 0 descendants of its own
- K170146: Galaxy UNYCO System (2017), 0 descendants of its own

## Recalls of this device
- Jun 10, 2026 · Class II · Z-2729-2026: Unilateral external fixation devices may be incorrectly labeled. Minirail M101 was labeled as M103, Minirail M103 was labeled as M101, and Minirail M122 was labeled as M111
- Jun 10, 2026 · Class II · Z-2731-2026: Unilateral external fixation devices may be incorrectly labeled. Minirail M101 was labeled as M103, Minirail M103 was labeled as M101, and Minirail M122 was labeled as M111
- Jun 10, 2026 · Class II · Z-2732-2026: Unilateral external fixation devices may be incorrectly labeled. Minirail M101 was labeled as M103, Minirail M103 was labeled as M101, and Minirail M122 was labeled as M111
- Jun 10, 2026 · Class II · Z-2730-2026: Unilateral external fixation devices may be incorrectly labeled. Minirail M101 was labeled as M103, Minirail M103 was labeled as M101, and Minirail M122 was labeled as M111
- Sep 27, 2018 · Class II · Z-0396-2020: 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
- Sep 27, 2018 · Class II · Z-0397-2020: 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
- Sep 27, 2018 · Class II · Z-0398-2020: 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
- Sep 27, 2018 · Class II · Z-0401-2020: 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
- Sep 27, 2018 · Class II · Z-0402-2020: 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
- Sep 27, 2018 · Class II · Z-0394-2020: 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
- Sep 27, 2018 · Class II · Z-0395-2020: 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
- Sep 27, 2018 · Class II · Z-0399-2020: 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
- Sep 27, 2018 · Class II · Z-0400-2020: 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 Fixation System and is intended to be used for bone stabilization in trauma and orthopedic procedures, both on adults and all pediatric subgroups patients except newborns, as required. The indications for use include: - Open or closed fractures in long bones; - Vertically stable pelvic fractures or as a treatment adjunct for vertically unstable pelvic fractures; - Infected and aseptic non-unions; - joint pathologies/injuries of upper and lower limbs such as: * proximal humeral fractures; * intra-articular knee, ankle and wrist fractures; * Delayed treatment of dislocated and stiff elbows; * Chronic, persistent elbow joint instability; * Acute elbow joint instability after complex ligament injuries; * Unstable elbow fractures; * Additional elbow stabilization of post-operative unstable internal fixation.

Source page: https://510kreport.com/device/K113770
Methodology: https://510kreport.com/methodology