# K250866: Sovereign Posterior Cervical System

- Pathway: 510(k) (Traditional)
- Applicant: Met One Technologies, LLC
- Decided: May 20, 2025 after 57 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: 16 generations back to K003155 (2001). 184 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 186 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K131833: Centurion Poct System, Orthofix, Inc. (2014) Summary page 5.
- K162575: Z-LINKPC System, Zavation, LLC (2017) Summary page 5.
- K142838: Synapse Occipital-Cervical-Thoracic (OCT) System, Synthes USA Products, LLC (2015) Summary page 5.
- K192013: VERTICALE® Cervical System, Silony Medical GmbH (2020) Summary page 5.
- K170108: Xultan 5.5 Pedicle Screw System, Met One Technologies (2017) Summary page 5.

## Most influential descendants
- K254260: The VEGA Cervical Screw System (2026), 0 descendants of its own

## Indications for use
The Sovereign Posterior Cervical System is intended to provide immobilization and stabilization of spinal segments as an adjunct to fusion for the following acute and chronic instabilities of the cervical spine (C1 to C7) and the 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 Sovereign Posterior Cervical 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 Sovereign Posterior Cervical System may be connected to the Xultan 5.5 system using rod-to-rod connectors or transition rods. Please refer to the individual system’s Instructions for Use for a list of indications for use for each system.

Source page: https://510kreport.com/device/K250866
Methodology: https://510kreport.com/methodology