# K230861: VADER® Pedicle System Navigated Instruments

- Pathway: 510(k) (Traditional)
- Applicant: Icotec AG
- Decided: Jun 27, 2023 after 90 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). 211 ancestors in all.
No later device cites it as a predicate yet.
0 of 212 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K223649: VERTICALE® Navigation Instruments, Silony Medical GmbH (2022) Summary page 6.

## Indications for use
icotec Navigation Instruments are intended to be used during the preparation and placement of FDA-cleared icotec pedicle screws during spinal surgery to assist the surgeon in precisely locating anatomical structures. 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/K230861
Methodology: https://510kreport.com/methodology