# K220132: FIREFLY® Cervical Navigation Guide

- Pathway: 510(k) (Traditional)
- Applicant: Mighty Oak Medical, Inc.
- Decided: Oct 26, 2022 after 281 days
- Product code: QSD (Posterior Cervical Screw Placement Guide)
- Device class: 2
- Regulation: 21 CFR 888.3075
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 5 generations back to K953076 (1997). 6 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 8 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K153631: Zimmer Virage OCT Spinal Fixation System, Zimmer Spine, Inc. (2016) Summary page 4.

## Most influential descendants
- K231515: MySpine Cervical Guides (2023), 0 descendants of its own

## Indications for use
The FIREFLY® Cervical Navigation Guide system is intended to provide mechanical guidance for the preparation and drilling of pilot holes for the placement of posterior cervical screws in the cervical spine (C1-C7) and the upper thoracic spine (T1-T3). Pilot holes are created using the FIREFLY® Cervical Navigation Guide in the pedicles (C2-T3), Pars (C2), or lateral masses (C1) during open, posterior spinal fixation procedures, on skeletally mature patients, that are intended for fusion. The patient's pedicles, pars, or lateral masses must be dimensionally adequate to safely accommodate a posterior cervical screw, as determined on a preoperative CT/CTA scan. The FIREFLY® Cervical Navigation Guide system is compatible with FDA cleared, legally marketed, posterior cervical screw systems (and their respective compatible components) that are specified in the precautions. Pedicle sounding probes (a.k.a. feeler/ball-tip probes) may be used to confirm each pedicle's integrity. Only qualified compatible OEM posterior cervical screw system taps may be used to visually guide the tapping of pilot holes. All other posterior cervical screw system components and accessories (including non-visually guided taps) are to be used, after removal of the FIREFLY® Cervical Navigation Guide, as directed by the posterior cervical screw system's instructions for use. The FIREFLY® Cervical Navigation Guide system is only compatible with Power drill consoles systems (attachments and burs) listed in the precautions. This system (guide, bone model, drill bit, and depth stop) are intended for single use only.

Source page: https://510kreport.com/device/K220132
Methodology: https://510kreport.com/methodology