# K253921: VERTICALE® Navigation Instruments

- Pathway: 510(k) (Traditional)
- Applicant: Silony Medical GmbH
- Decided: Jun 26, 2026 after 200 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: 18 generations back to K040583 (2004). 212 ancestors in all.
No later device cites it as a predicate yet.
0 of 213 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K173338: Navigated INFINITY™ Instruments, Medtronic Sofamor Danek USA, Inc. (2018) Summary page 6.
- K223649: VERTICALE® Navigation Instruments, Silony Medical GmbH (2022) Summary page 6.

## Indications for use
The VERTICALE® Navigation Instruments are indicated for use during the preparation and insertion of VERTICALE® and VERTICALE® CERVICAL screws during spinal surgery to assist the surgeon in precisely locating anatomical structures in either open or minimally invasive procedures. These instruments are designed for use with the third party stereotactic navigation systems (Medtronic StealthStation™, Brainlab or 7D) software which are indicated for any medical condition in which the use of stereotactic surgery is suitable, and where reference to a rigid anatomical structure, such as vertebra, can be identified relative to a CT or MR based model, fluoroscopy images, or digitized orientation points of the anatomy.

Source page: https://510kreport.com/device/K253921
Methodology: https://510kreport.com/methodology