# K143222: FIREFLY Pedicle Screw Navigation Guide

- Pathway: 510(k) (Traditional)
- Applicant: Mighty Oak Medical, Inc.
- Decided: Dec 11, 2015 after 396 days
- Product code: MNI (Orthosis, Spinal Pedicle Fixation)
- Device class: 2
- Regulation: 21 CFR 888.3070
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 14 generations back to K040583 (2004). 144 ancestors in all.
8 later devices descend from it; 1 cites it directly.
1 of 153 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K132788: Myspine Pedicle Screw Placement Guides, Medacta International (2014) Summary page 5.

## Most influential descendants
- K162419: FIREFLY® Pedicle Screw Navigation Guide (2016), 7 descendants of its own
- K181399: FIREFLY® Pedicle Screw Navigation Guide (2018), 5 descendants of its own
- K181883: FIREFLY® Midline Navigation Guide (2018), 4 descendants of its own
- K203673: MySpine Pedicle Screw Placement Guides Extension (MySpine Low Profile Guides, MySpine MC and Drill Pilot Guides, and MySpine S2-Alar/Alar Iliac Guides) (2021), 3 descendants of its own
- K220888: MySpine S2-SI Pedicle and Sacro-Iliac Screw Placement Guides (2022), 1 descendant of its own

## Indications for use
The FIREFLY™ Pedicle Screw Navigation Guide is a patient-specific system intended to guide the drilling and tapping of pilot holes for placement of pedicle screws according to surgeon-prescribed pre-operatively planned trajectories during open, posterior, instrumented spinal surgery (T1-S1/Ilium). The FIREFLY™ Pedicle Screw Navigation Guide is intended for use with the pedicle screw spinal systems specified in the instructions for use and in patients consistent with the selected system’s cleared indications for use. Use of the FIREFLY™ Pedicle Screw Navigation Guide involves surgical planning software used pre-operatively to plan the surgical placement of the pilot holes on the basis of patient CT radiological images with identifiable placement of anatomical landmarks. Only compatible OEM taps that are supplied with the pedicle screw spinal systems specified in the instructions for use may be used through the FIREFLY™ Pedicle Screw Navigation Guide to tap pilot holes. All other pedicle screw spinal system components and accessories (including non-guided taps) are to be used after removal of the FIREFLY™ Pedicle Screw Navigation Guide, as directed by the pedicle screw spinal system’s instructions for use. This device is intended for single use only.

Source page: https://510kreport.com/device/K143222
Methodology: https://510kreport.com/methodology