# K182524: GALILEO Spine Alignment Monitoring System

- Pathway: 510(k) (Traditional)
- Applicant: MiRus, LLC
- Decided: Jun 17, 2019 after 277 days
- Product code: OLO (Orthopedic Stereotaxic Instrument)
- Device class: 2
- Regulation: 21 CFR 882.4560
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 8 generations back to K010612 (2001). 18 ancestors in all.
No later device cites it as a predicate yet.
0 of 19 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K133759: Intellijoint Hip, Intellijoint Surgical, Inc. (2014) Summary page 5.

## Indications for use
The GALILEO™ Spine Alignment Monitoring System is intended to provide intra-operative measurements to a surgeon to aid in the selection and positioning of orthopedic implant system components, relative to anatomical structures and reference axes. The GALILEO™ Spine Alignment Monitoring System is indicated for patients undergoing orthopedic spine surgery where the use of stereotactic surgery is considered safe and effective, and where a reference to a rigid spinal anatomical structure, such as a vertebral body, can be identified relative to the anatomy. The system aids the surgeon in controlling spinal VDJLWWDO alignment. Example spine surgical procedures include: - Spinal deformity correction - Spinal fusion

Source page: https://510kreport.com/device/K182524
Methodology: https://510kreport.com/methodology