# K254260: The VEGA Cervical Screw System

- Pathway: 510(k) (Traditional)
- Applicant: GS Medical Co., Ltd.
- Decided: Sep 17, 2026 after 262 days
- Product code: NKG (Posterior Cervical Screw System)
- Device class: 2
- Regulation: 21 CFR 888.3075
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 17 generations back to K003155 (2001). 185 ancestors in all.
No later device cites it as a predicate yet.
0 of 186 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K250866: Sovereign Posterior Cervical System, Met One Technologies, LLC (2025) Summary page 5.

## Indications for use
The VEGA Cervical Screw System is intended to provide immobilization and stabilization of spinal segments as an adjunct to fusion for the treatment of the following acute and chronic instabilities of the cervical spine (C1-C7) and the upper thoracic spine (T1-T3): traumatic spinal fractures and/or traumatic dislocations; instability or deformity; failed previous fusions (e.g. pseudoarthrosis); tumors involving the cervical/thoracic spine; and degenerative disease, including intractable radiculopathy and/or myelopathy, neck and/or arm pain of discogenic origin as confirmed by radiographic studies, and degenerative disease of the facets with instability. The VEGA Cervical Screw System is also intended to restore the integrity of the spinal column even in the absence of fusion for a limited time period in patients with advanced stage tumors involving the cervical spine in whom life expectancy is of insufficient duration to permit achievement of fusion. In order to achieve additional levels of fixation, the VEGA Cervical Screw System may be connected to the AnyPlus Il Spinal Fixation System, using compatible connectors or transition rods. Please refer to the individual system’s Instructions for Use for a complete list of indications for each system.

Source page: https://510kreport.com/device/K254260
Methodology: https://510kreport.com/methodology