# K192013: VERTICALE® Cervical System

- Pathway: 510(k) (Traditional)
- Applicant: Silony Medical GmbH
- Decided: Apr 7, 2020 after 253 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: 4 generations back to K953076 (1997). 5 ancestors in all.
2 later devices descend from it; 1 cites it directly.
0 of 8 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K151885: SUMMIT SI OCT Spinal Fixation System, MOUNTAINEER OCT Spinal System, Depuy Synthes, Inc. (2015) Summary page 4.

## Most influential descendants
- K250866: Sovereign Posterior Cervical System (2025), 1 descendant of its own
- K254260: The VEGA Cervical Screw System (2026), 0 descendants of its own

## Indications for use
The VERTICALE 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 craniocervical junction (occiput-C2), 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 - 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

Source page: https://510kreport.com/device/K192013
Methodology: https://510kreport.com/methodology