# K223649: VERTICALE® Navigation Instruments

- Pathway: 510(k) (Special)
- Applicant: Silony Medical GmbH
- Decided: Dec 22, 2022 after 16 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: 17 generations back to K040583 (2004). 210 ancestors in all.
3 later devices descend from it; 3 cite it directly.
0 of 214 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K212007: VERTICALE Navigation Instruments, Silony Medical GmbH (2021) Summary page 5.

## Most influential descendants
- K253921: VERTICALE® Navigation Instruments (2026), 0 descendants of its own
- K250167: Evolution Spine Navigation Instruments (2025), 0 descendants of its own
- K230861: VADER® Pedicle System Navigated Instruments (2023), 0 descendants of its own

## Indications for use
Silony Medical Navigation Instruments are intended to be used during the preparation and placement of VERTICALE® pedicle screws during spinal surgery to assist the surgeon in precise locating anatomical structures in spinal procedures. These instruments are designed for use with stereotactic navigation system Medtronic StealthStation®, which is indicated for any medical condition in which the use of stereotactic surgery may be appropriate, and where reference to a rigid anatomical structure, such as a vertebra, can be identified relative to a CT or MR based model, fluoroscopy images, or digitized landmarks of the anatomy.

Source page: https://510kreport.com/device/K223649
Methodology: https://510kreport.com/methodology