# K223511: Excella Navigation Instruments

- Pathway: 510(k) (Traditional)
- Applicant: Innovasis, Inc.
- Decided: May 2, 2023 after 161 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: 10 generations back to K862807 (1986). 63 ancestors in all.
3 later devices descend from it; 1 cites it directly.
0 of 67 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K140454: Navigated CD Horizon Solera Screwdriver/Taps, Medtronic Sofamor Danek USA, Inc. (2014)

## Most influential descendants
- K250182: Innovasis Navigation Instruments (2025), 2 descendants of its own
- K252962: DYNAMIS™ Navigation System (2026), 0 descendants of its own
- K251073: Innovasis Navigation Instruments (Vector G-E Navigation Instruments and the Excella G-E Navigation Instruments) (2025), 0 descendants of its own

## Indications for use
The Excella® Navigation Instruments are intended to be used during the preparation and placement of Excella II®, Excella 3® & Excella MIS® screws during spinal surgery to assist the surgeon in locating anatomical structures in either open or percutaneous spinal procedures. The Excella Navigation Instruments are specifically designed for use with the Medtronic® StealthStation® System SB and associated tracking arrays, 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 an acquired image (CT, MR, 2D/3D fluoroscopic image reconstruction) and/or an image-based model of the anatomy.

Source page: https://510kreport.com/device/K223511
Methodology: https://510kreport.com/methodology