510(k) · Cleared
ClearedFIREFLY® Cervical Navigation Guide
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Mighty Oak Medical, Inc. · QSD Posterior Cervical Screw Placement Guide
Cleared on Oct 26, 2022 as substantially equivalent to K153631 (Zimmer Spine, Inc., 2016) after a 281-day review. Its family tree reaches back 5 generations to 1997. 1 later device descends from it.
- Decided
- Oct 26, 2022
- Review
- 281 days
- Class
- Class II
- Product code
- QSD
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 5 generations to K953076 (1997). 6 ancestors in all. 1 later device descends from it, 1 citing it directly.
- Root · 5 generations backK953076 Townley Facet/Pedicular Screw Plating SystemSofamor Danek USA,Inc. · 1997
- 4 generations backK062254 Axis Fixation SystemMedtronic Sofamor Danek, Inc. · 2008
- 3 generations backK143471 VERTEX Reconstruction SystemMedtronic Sofamor Danek USA, Inc. · 2015
- 2 generations backK151031 Virage OCT Spinal Fixation SystemZimmer Spine, Inc. · 2015
- 1 generation backK153631 Zimmer Virage OCT Spinal Fixation SystemZimmer Spine, Inc. · 2016
- This deviceK220132 FIREFLY® Cervical Navigation GuideMighty Oak Medical, Inc. · 2022
- Descendant · cites it directly · 0 of its ownK231515 MySpine Cervical GuidesMedacta International S.A. · 2023
Most influential descendants
Showing 1 of 1 · See all- K231515MySpine Cervical GuidesMedacta International S.A. · 2023 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −5 | K953076 | Townley Facet/Pedicular Screw Plating System | Sofamor Danek USA,Inc. | 1997 | — |
| −4 | K062254 | Axis Fixation System | Medtronic Sofamor Danek, Inc. | 2008 | — |
| −3 | K143471 | VERTEX Reconstruction System | Medtronic Sofamor Danek USA, Inc. | 2015 | — |
| −2 | K151031 | Virage OCT Spinal Fixation System | Zimmer Spine, Inc. | 2015 | — |
| −1 | K153631 | Zimmer Virage OCT Spinal Fixation System | Zimmer Spine, Inc. | 2016 | — |
| 0 (this device) | K220132 | FIREFLY® Cervical Navigation Guide | Mighty Oak Medical, Inc. | 2022 | — |
| +1 | K231515 | MySpine Cervical Guides | Medacta International S.A. | 2023 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2002 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2023 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in QSD? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
Top candidate predicates for a new QSD device
- #1 K231515 MySpine Cervical Guidesscore 11.6 · 18 generations · no Class I recall
What was it cleared against? (1)
Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K153631 | Zimmer Virage OCT Spinal Fixation SystemSummary page 4…te Device(s): FIREFLY® Cervical Navigation Guide 510(k) Product Code Trade Name Manufacturer Primary Predicate Device K153631 NKG Virage OCT Spinal System Zimmer Reference Device K181399 PQC FIR… | 2016 |
| † | K181399 | FIREFLY® Pedicle Screw Navigation Guide | 2018 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K231515 | MySpine Cervical Guides | 2023 | 0 |
Has anything in its family been recalled? (0 Class I)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 25 years and passes through 5 companies; a new generation was cleared every 6.6 years on median.
- None of the 6 ancestors has a recall.
- Of its descendants, K231515 (Medacta International S.A., 2023) has gone furthest, with 0 descendants of its own.
- 9 other devices also cite its predicate K153631.
How does its category compare?
All QSD devicesQSD Posterior Cervical Screw Placement Guide: FDA decisions, review times, recalls and adverse event reports over 20 years. 2022, this device’s year, is highlighted.
FDA decisions per year · QSD
1in 2023
2026 to Oct 25, outlined.
Median 510(k) review, days · QSD
Too few QSD 510(k)s in any year since 2007 to give a median.
Recalls per year · QSD
No recall names QSD since 2007.
Adverse event reports per year · QSD
No MAUDE report names QSD since 2007.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 0 | — | 0 | 0 |
| 2008 | 0 | — | 0 | 0 |
| 2009 | 0 | — | 0 | 0 |
| 2010 | 0 | — | 0 | 0 |
| 2011 | 0 | — | 0 | 0 |
| 2012 | 0 | — | 0 | 0 |
| 2013 | 0 | — | 0 | 0 |
| 2014 | 0 | — | 0 | 0 |
| 2015 | 0 | — | 0 | 0 |
| 2016 | 0 | — | 0 | 0 |
| 2017 | 0 | — | 0 | 0 |
| 2018 | 0 | — | 0 | 0 |
| 2019 | 0 | — | 0 | 0 |
| 2020 | 0 | — | 0 | 0 |
| 2021 | 0 | — | 0 | 0 |
| 2022 | 1 | — | 0 | 0 |
| 2023 | 1 | — | 0 | 0 |
| 2024 | 0 | — | 0 | 0 |
| 2025 | 0 | — | 0 | 0 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
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…
Read the full statement (233 words)
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.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K220132 · printed Nov 6, 2026
Cite this page
510(k) Report. “K220132: FIREFLY® Cervical Navigation Guide.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K220132
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026