510(k) · Cleared
ClearedFIREFLY® Pedicle Screw Navigation Guide
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Mighty Oak Medical · PQC Pedicle Screw Placement Guide
Cleared on Feb 25, 2026 as substantially equivalent to K181399 (Mighty Oak Medical, Inc., 2018) after a 138-day review. Its family tree reaches back 17 generations to 2004. 1 of the 148 devices in its family, counting itself, has a Class I recall.
- Decided
- Feb 25, 2026
- Review
- 138 days
- Class
- Class II
- Product code
- PQC
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 17 generations to K040583 (2004). 147 ancestors in all, the oldest K781443 (1978). No later device cites it as a predicate yet. 1 of the 148 devices in this family, counting this one, has a Class I recall.
- Root · 17 generations backK040583 Modification to: CD Horizon Spinal SystemMedtronic Sofamor Danek · 2004
- 13 generations between
- 3 generations backK143222 FIREFLY Pedicle Screw Navigation GuideMighty Oak Medical, Inc. · 2015
- 2 generations backK162419 FIREFLY® Pedicle Screw Navigation GuideMighty Oak Medical, Inc. · 2016
- 1 generation backK181399 FIREFLY® Pedicle Screw Navigation GuideMighty Oak Medical, Inc. · 2018
- This deviceK253472 FIREFLY® Pedicle Screw Navigation GuideMighty Oak Medical · 2026
Show all 17 generations
- Root · 17 generations backK040583 Modification to: CD Horizon Spinal SystemMedtronic Sofamor Danek · 2004
- 16 generations backK041118 Modification to CD Horizon Spinal SystemMedtronic Sofamor Danek · 2004
- 15 generations backK042025 Modification to CD Horizon Spinal SystemMedtronic Sofamor Danek, Inc. · 2004 · Recalled
- 14 generations backK043151 Modification to: CD Horizon Spinal SystemMedtronic Sofamor Danek · 2005
- 13 generations backK050809 CD Horizon Spinal SystemMedtronic Sofamor Danek USA, Inc. · 2005
- 12 generations backK052187 Modification to: CD Horizon Spinal SystemMedtronic Sofamor Danek · 2005
- 11 generations backK053101 CD Horizon Spinal SystemMedtronic Sofamor Danek · 2006
- 10 generations backK091442 CD Horizon Spinal SystemMedtronic Sofamor Danek · 2009
- 9 generations backK091974 Modification to CD Horizon Spinal SystemMedtronic Sofamor Danek USA, Inc. · 2009 · Recalled
- 8 generations backK102555 CD Horizon Spinal SystemMedtronic Sofamor Danek USA, Inc. · 2010
- 7 generations backK112473 CD Horizon Spinal SystemMedtronic Sofamor Danek, Inc. · 2011
- 6 generations backK113174 CD Horizon Spinal SystemMedtronic Sofamor Danek USA, Inc. · 2011 · Recalled
- 5 generations backK121115 M.U.S.T Pedicle Screw SystemMedacta International · 2012 · Recalled
- 4 generations backK132788 Myspine Pedicle Screw Placement GuidesMedacta International · 2014
- 3 generations backK143222 FIREFLY Pedicle Screw Navigation GuideMighty Oak Medical, Inc. · 2015
- 2 generations backK162419 FIREFLY® Pedicle Screw Navigation GuideMighty Oak Medical, Inc. · 2016
- 1 generation backK181399 FIREFLY® Pedicle Screw Navigation GuideMighty Oak Medical, Inc. · 2018
- This deviceK253472 FIREFLY® Pedicle Screw Navigation GuideMighty Oak Medical · 2026
Class I recalls in this family
- K100952 Modification to Synthes Matrix System6 generations back · 2010
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −17 | K040583 | Modification to: CD Horizon Spinal System | Medtronic Sofamor Danek | 2004 | — |
| −16 | K041118 | Modification to CD Horizon Spinal System | Medtronic Sofamor Danek | 2004 | — |
| −15 | K042025 | Modification to CD Horizon Spinal System | Medtronic Sofamor Danek, Inc. | 2004 | 4 |
| −14 | K043151 | Modification to: CD Horizon Spinal System | Medtronic Sofamor Danek | 2005 | — |
| −13 | K050809 | CD Horizon Spinal System | Medtronic Sofamor Danek USA, Inc. | 2005 | — |
| −12 | K052187 | Modification to: CD Horizon Spinal System | Medtronic Sofamor Danek | 2005 | — |
| −11 | K053101 | CD Horizon Spinal System | Medtronic Sofamor Danek | 2006 | — |
| −10 | K091442 | CD Horizon Spinal System | Medtronic Sofamor Danek | 2009 | — |
| −9 | K091974 | Modification to CD Horizon Spinal System | Medtronic Sofamor Danek USA, Inc. | 2009 | 1 |
| −8 | K102555 | CD Horizon Spinal System | Medtronic Sofamor Danek USA, Inc. | 2010 | — |
| −7 | K112473 | CD Horizon Spinal System | Medtronic Sofamor Danek, Inc. | 2011 | — |
| −6 | K113174 | CD Horizon Spinal System | Medtronic Sofamor Danek USA, Inc. | 2011 | 1 |
| −5 | K121115 | M.U.S.T Pedicle Screw System | Medacta International | 2012 | 1 |
| −4 | K132788 | Myspine Pedicle Screw Placement Guides | Medacta International | 2014 | — |
| −3 | K143222 | FIREFLY Pedicle Screw Navigation Guide | Mighty Oak Medical, Inc. | 2015 | — |
| −2 | K162419 | FIREFLY® Pedicle Screw Navigation Guide | Mighty Oak Medical, Inc. | 2016 | — |
| −1 | K181399 | FIREFLY® Pedicle Screw Navigation Guide | Mighty Oak Medical, Inc. | 2018 | — |
| 0 (this device) | K253472 | FIREFLY® Pedicle Screw Navigation Guide | Mighty Oak Medical | 2026 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1978 | 1 | 0 |
| 1984 | 1 | 0 |
| 1990 | 2 | 0 |
| 1992 | 5 | 0 |
| 1993 | 2 | 0 |
| 1994 | 1 | 0 |
| 1995 | 3 | 0 |
| 1996 | 3 | 0 |
| 1997 | 3 | 0 |
| 1998 | 4 | 0 |
| 1999 | 4 | 0 |
| 2000 | 13 | 0 |
| 2001 | 11 | 0 |
| 2002 | 7 | 0 |
| 2003 | 13 | 0 |
| 2004 | 17 | 0 |
| 2005 | 13 | 0 |
| 2006 | 8 | 0 |
| 2007 | 6 | 0 |
| 2008 | 4 | 0 |
| 2009 | 3 | 0 |
| 2010 | 5 | 1 |
| 2011 | 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.
1 device in this family has a Class I recall. 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 PQC device
- #1 K203673 MySpine Pedicle Screw Placement Guides…score 14.9 · 17 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
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 |
|---|---|---|---|
| * | K181399 | FIREFLY® Pedicle Screw Navigation GuideSummary page 5…l Submission: Traditional. Predicate Device(s): 510(k) Product Code Trade Name Manufacturer Primary Predicate Device K181399 PQC FIREFLY® Pedicle Screw Navigation Guide Mighty Oak Medical Introduction This 510(k) filing seeks to ex… | 2018 |
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (1 Class I)
No FDA recall names this device.
Relatives with a Class I recall
Class I is FDA’s most serious recall class. A recall in the family tree is context for this device, not evidence about it.
- K100952Modification to Synthes Matrix SystemSynthes Spine · 2010 · 6 generations back · ◆ in the 2010 ancestors bar of FIG. 11 Class I recall
What does this lineage say?
- The line of descent spans 22 years and passes through 6 companies; a new generation was cleared every 8 months on median.
- 22 of the 147 ancestors have a recall of any class; 1 has a Class I recall.
- 1 other device also cites its predicate K181399.
How does its category compare?
All PQC devicesPQC Pedicle Screw Placement Guide: FDA decisions, review times, recalls and adverse event reports over 20 years. 2026, this device’s year, is highlighted.
FDA decisions per year · PQC
1in 2023
2026 to Oct 25, outlined.
Median 510(k) review, days · PQC
82in 2018
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · PQC
No recall names PQC since 2007.
Adverse event reports per year · PQC
1in 2025
MAUDE reports naming product code PQC, not matched to any one device; reports are not rates.
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 | 1 | — | 0 | 0 |
| 2017 | 0 | — | 0 | 0 |
| 2018 | 3 | 82 | 0 | 3 |
| 2019 | 0 | — | 0 | 4 |
| 2020 | 1 | — | 0 | 2 |
| 2021 | 1 | — | 0 | 3 |
| 2022 | 0 | — | 0 | 0 |
| 2023 | 1 | — | 0 | 3 |
| 2024 | 0 | — | 0 | 2 |
| 2025 | 0 | — | 0 | 1 |
| 2026 | 1 | — | 0 | — |
What is it indicated for?
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: • Pedicle screw's shank is straight along its longitudinal axis (i.e. not curved) • Pedicle screw's…
Read the full statement (226 words)
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:
• Pedicle screw's shank is straight along its longitudinal axis (i.e. not curved)
• Pedicle screw's major and minor thread diameters are centered about the longitudinal axis
• Pedicle screw's longitudinal axis matches the direction of insertion
• Pedicle screw is intended to be inserted into a pilot hole
• Pedicle screw's diameter is larger than the pilot hole created with FIREFLY®
• Patient's pedicle must be dimensionally adequate to accommodate a pedicle screw, as determined on preoperative scan
• 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.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K253472 · printed Nov 4, 2026
Cite this page
510(k) Report. “K253472: FIREFLY® Pedicle Screw Navigation Guide.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K253472
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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