# K181399: FIREFLY® Pedicle Screw Navigation Guide

- Pathway: 510(k) (Traditional)
- Applicant: Mighty Oak Medical, Inc.
- Decided: Jul 24, 2018 after 56 days
- Product code: PQC (Pedicle Screw Placement Guide)
- 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: 16 generations back to K040583 (2004). 146 ancestors in all.
5 later devices descend from it; 2 cite it directly.
1 of 152 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K162419: FIREFLY® Pedicle Screw Navigation Guide, Mighty Oak Medical, Inc. (2016) Summary page 4.

## Most influential descendants
- 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
- K253472: FIREFLY® Pedicle Screw Navigation Guide (2026), 0 descendants of its own
- K231515: MySpine Cervical Guides (2023), 0 descendants of its own
- K231483: MySpine Unilateral Guides (2023), 0 descendants of its own

## Indications for use
The FIREFLY® Pedicle Screw Navigation Guide can be used with any 510(k) cleared, legally marketed, pedicle screw spinal system (for its cleared indications for use) and its respective compatible components for non-cervical open, posterior spinal fixation procedures (T1-S2/S2AI and ilium) intended for fusion, with the additional conditions listed below: x Pedicle screw’s shank is straight along its longitudinal axis (i.e. not curved) x Pedicle screw’s major and minor thread diameters are centered about the longitudinal axis x Pedicle screw’s longitudinal axis matches the direction of insertion x Pedicle screw is intended to be inserted into a pilot hole x Pedicle screw’s diameter is larger than the pilot hole created with FIREFLY® x Patient’s pedicle must be dimensionally adequate to accommodate a pedicle screw, as determined on preoperative scan x Compatible pedicle screw spinal system instruments may be used with the FIREFLY® Pedicle Screw Navigation Guide o Pedicle sounding probes (a.k.a. feeler/ball-tip probes) may be used to confirm pedicle integrity o Only OEM pedicle screw spinal system taps specified in the Approved Patient-Specific Surgical Plan may be guided to tap pilot holes o 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/K181399
Methodology: https://510kreport.com/methodology