# K252088: Firebird SI Navigation System

- Pathway: 510(k) (Traditional)
- Applicant: Orthofix US, LLC
- Decided: Oct 31, 2025 after 121 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: 20 generations back to K930834 (1993). 385 ancestors in all.
1 later device descends from it; 1 cites it directly.
2 of 387 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K172517: SeaSpine Navigation System, SeaSpine Orthopedics Corporation (2018) Summary page 5.
- K201189: Stealthstation S8 Spine Software v1.3.0, Medtronic Navigation, Inc. (2020) Summary page 5.
- K211710: Ascent POCT System, Centurion POCT System, Spinal Fixation System (SFS), Firebird Spinal Fixation Systems: (Firebird Deformity Spinal Fixation System, Phoenix MIS Spinal Fixation System, Phoenix CDX MIS Spinal Fixation System, JANUS Midline Fixation Screws, Firebird NXG Spinal Fixation System, JANUS Fenestrated Screws), Connector System, FIREBIRD SI Fusion System, Orthofix, Inc. (2021) Summary page 5.

## Most influential descendants
- K260571: SIMPACT Sacroiliac Joint Fixation System GX Navigation Instruments (2026), 0 descendants of its own

## Indications for use
The Firebird SI Navigation System instruments are intended to be used during the preparation and placement of Orthofix Firebird SI Fusion System screws during spinal surgery to assist the surgeon in precisely locating anatomical structures in either open or minimally invasive procedures. The Firebird SI Navigation instruments are specifically designed for use with the Medtronic StealthStation System, 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 or pelvis can be identified relative to a CT or MR based model, fluoroscopy images, or digitized landmarks for the anatomy.

Source page: https://510kreport.com/device/K252088
Methodology: https://510kreport.com/methodology