# K143110: GALAXY MIS Screw System

- Pathway: 510(k) (Traditional)
- Applicant: Bm Korea
- Decided: Jun 24, 2015 after 238 days
- Product code: NKB (Thoracolumbosacral Pedicle Screw System)
- Device class: 2
- Regulation: 21 CFR 888.3070
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 9 generations back to K950697 (1995). 86 ancestors in all.
2 later devices descend from it; 1 cites it directly.
0 of 89 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K120353: Synster Pedicle Screw System Synster Plus Pedicle Screw System, Bm Korea Co., Ltd. (2012) Summary page 4.
- K091717: Any Plus Spinal Fixation System, GS Medical Co., Ltd. (2010) Summary page 4.
- K112643: Focus Mis System, L&K BIOMED Co., Ltd. (2012) Summary page 4.
- K120140: Focus Spinal System, L&K BIOMED Co., Ltd. (2012) Summary page 4.

## Most influential descendants
- K201788: EDEN Spinal Fixation System (2022), 1 descendant of its own
- K230762: EDEN Spinal Fixation MIS System (2023), 0 descendants of its own

## Indications for use
The GALAXY MIS Screw System is intended to provide immobilization and stabilization of the posterior, non-cervical spine as an adjunct to fusion in skeletally mature patients for the following indications: degenerative disc disease (defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies), spondylolisthesis, trauma (i.e., fracture or dislocation), spinal stenosis, curvatures (i.e., scoliosis, kyphosis and/or lordosis), tumor, pseudarthrosis, and/or failed previous fusion. The GALAXY MIS Screw System can be used in an open approach and a percutaneous approach with MIS instrumentation.

Source page: https://510kreport.com/device/K143110
Methodology: https://510kreport.com/methodology