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, Inc. · PQC Pedicle Screw Placement Guide
Cleared on Jul 24, 2018 as substantially equivalent to K162419 (Mighty Oak Medical, Inc., 2016) after a 56-day review. Its family tree reaches back 16 generations to 2004. 1 of the 152 devices in its family, counting itself, has a Class I recall. 5 later devices descend from it.
- Decided
- Jul 24, 2018
- Review
- 56 days
- Class
- Class II
- Product code
- PQC
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 16 generations to K040583 (2004). 146 ancestors in all, the oldest K781443 (1978). 5 later devices descend from it, 2 citing it directly. 1 of the 152 devices in this family, counting this one, has a Class I recall.
- Root · 16 generations backK040583 Modification to: CD Horizon Spinal SystemMedtronic Sofamor Danek · 2004
- 12 generations between
- 3 generations backK132788 Myspine Pedicle Screw Placement GuidesMedacta International · 2014
- 2 generations backK143222 FIREFLY Pedicle Screw Navigation GuideMighty Oak Medical, Inc. · 2015
- 1 generation backK162419 FIREFLY® Pedicle Screw Navigation GuideMighty Oak Medical, Inc. · 2016
- This deviceK181399 FIREFLY® Pedicle Screw Navigation GuideMighty Oak Medical, Inc. · 2018
- Descendant · cites it directly · 3 of its ownK203673 MySpine Pedicle Screw Placement Guides Extension (MySpine Low…Medacta International S.A. · 2021
- Descendant · 2 generations on · 1 of its ownK220888 MySpine S2-SI Pedicle and Sacro-Iliac Screw Placement GuidesMedacta International S.A. · 2022
- Descendant · cites it directly · 0 of its ownK253472 FIREFLY® Pedicle Screw Navigation GuideMighty Oak Medical · 2026
- Descendant · 2 generations on · 0 of its ownK231515 MySpine Cervical GuidesMedacta International S.A. · 2023
- Descendant · 2 generations on · 0 of its ownK231483 MySpine Unilateral GuidesMedacta International S.A. · 2023
Show all 16 generations
- Root · 16 generations backK040583 Modification to: CD Horizon Spinal SystemMedtronic Sofamor Danek · 2004
- 15 generations backK041118 Modification to CD Horizon Spinal SystemMedtronic Sofamor Danek · 2004
- 14 generations backK042025 Modification to CD Horizon Spinal SystemMedtronic Sofamor Danek, Inc. · 2004 · Recalled
- 13 generations backK043151 Modification to: CD Horizon Spinal SystemMedtronic Sofamor Danek · 2005
- 12 generations backK050809 CD Horizon Spinal SystemMedtronic Sofamor Danek USA, Inc. · 2005
- 11 generations backK052187 Modification to: CD Horizon Spinal SystemMedtronic Sofamor Danek · 2005
- 10 generations backK053101 CD Horizon Spinal SystemMedtronic Sofamor Danek · 2006
- 9 generations backK091442 CD Horizon Spinal SystemMedtronic Sofamor Danek · 2009
- 8 generations backK091974 Modification to CD Horizon Spinal SystemMedtronic Sofamor Danek USA, Inc. · 2009 · Recalled
- 7 generations backK102555 CD Horizon Spinal SystemMedtronic Sofamor Danek USA, Inc. · 2010
- 6 generations backK112473 CD Horizon Spinal SystemMedtronic Sofamor Danek, Inc. · 2011
- 5 generations backK113174 CD Horizon Spinal SystemMedtronic Sofamor Danek USA, Inc. · 2011 · Recalled
- 4 generations backK121115 M.U.S.T Pedicle Screw SystemMedacta International · 2012 · Recalled
- 3 generations backK132788 Myspine Pedicle Screw Placement GuidesMedacta International · 2014
- 2 generations backK143222 FIREFLY Pedicle Screw Navigation GuideMighty Oak Medical, Inc. · 2015
- 1 generation backK162419 FIREFLY® Pedicle Screw Navigation GuideMighty Oak Medical, Inc. · 2016
- This deviceK181399 FIREFLY® Pedicle Screw Navigation GuideMighty Oak Medical, Inc. · 2018
Class I recalls in this family
- K100952 Modification to Synthes Matrix System5 generations back · 2010
Most influential descendants
Showing 5 of 5 · See all- K203673MySpine Pedicle Screw Placement Guides Extension (MySpine Low Profile Guides, MySpine MC…Medacta International S.A. · 2021 · cites it directly3descendants
- K220888MySpine S2-SI Pedicle and Sacro-Iliac Screw Placement GuidesMedacta International S.A. · 2022 · 2 generations on1descendant
- K253472FIREFLY® Pedicle Screw Navigation GuideMighty Oak Medical · 2026 · cites it directly0descendants
- K231515MySpine Cervical GuidesMedacta International S.A. · 2023 · 2 generations on0descendants
- K231483MySpine Unilateral GuidesMedacta International S.A. · 2023 · 2 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −16 | K040583 | Modification to: CD Horizon Spinal System | Medtronic Sofamor Danek | 2004 | — |
| −15 | K041118 | Modification to CD Horizon Spinal System | Medtronic Sofamor Danek | 2004 | — |
| −14 | K042025 | Modification to CD Horizon Spinal System | Medtronic Sofamor Danek, Inc. | 2004 | 4 |
| −13 | K043151 | Modification to: CD Horizon Spinal System | Medtronic Sofamor Danek | 2005 | — |
| −12 | K050809 | CD Horizon Spinal System | Medtronic Sofamor Danek USA, Inc. | 2005 | — |
| −11 | K052187 | Modification to: CD Horizon Spinal System | Medtronic Sofamor Danek | 2005 | — |
| −10 | K053101 | CD Horizon Spinal System | Medtronic Sofamor Danek | 2006 | — |
| −9 | K091442 | CD Horizon Spinal System | Medtronic Sofamor Danek | 2009 | — |
| −8 | K091974 | Modification to CD Horizon Spinal System | Medtronic Sofamor Danek USA, Inc. | 2009 | 1 |
| −7 | K102555 | CD Horizon Spinal System | Medtronic Sofamor Danek USA, Inc. | 2010 | — |
| −6 | K112473 | CD Horizon Spinal System | Medtronic Sofamor Danek, Inc. | 2011 | — |
| −5 | K113174 | CD Horizon Spinal System | Medtronic Sofamor Danek USA, Inc. | 2011 | 1 |
| −4 | K121115 | M.U.S.T Pedicle Screw System | Medacta International | 2012 | 1 |
| −3 | K132788 | Myspine Pedicle Screw Placement Guides | Medacta International | 2014 | — |
| −2 | K143222 | FIREFLY Pedicle Screw Navigation Guide | Mighty Oak Medical, Inc. | 2015 | — |
| −1 | K162419 | FIREFLY® Pedicle Screw Navigation Guide | Mighty Oak Medical, Inc. | 2016 | — |
| 0 (this device) | K181399 | FIREFLY® Pedicle Screw Navigation Guide | Mighty Oak Medical, Inc. | 2018 | — |
| +1 | K203673 | MySpine Pedicle Screw Placement Guides Extension (MySpine Low Profile Guides… | Medacta International S.A. | 2021 | — |
| +2 | K220888 | MySpine S2-SI Pedicle and Sacro-Iliac Screw Placement Guides | Medacta International S.A. | 2022 | — |
| +1 | K253472 | FIREFLY® Pedicle Screw Navigation Guide | Mighty Oak Medical | 2026 | — |
| +2 | K231515 | MySpine Cervical Guides | Medacta International S.A. | 2023 | — |
| +2 | K231483 | MySpine Unilateral Guides | Medacta International S.A. | 2023 | — |
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 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2021 | 1 | 0 |
| 2022 | 1 | 0 |
| 2023 | 2 | 0 |
| 2026 | 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 K253472 FIREFLY® Pedicle Screw Navigation Guidescore 15.7 · 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 |
|---|---|---|---|
| * | K162419 | FIREFLY® Pedicle Screw Navigation GuideSummary page 4…R 888.3070, Thoracolumbosacral pedicle screw system Device Product Code: PQC Predicate Device(s): FIREFLY® Pedicle Screw Navigation Guide Primary Predicate: K162419 (S.E. 10/28/2016) Description The FIREFLY® Pedicle Screw Navigation Guide is intended to assist in the accurate placement of p… | 2016 |
What descends from it? (5)
2 later devices cite it directly; ranked here by how many devices descend from each in turn.
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 · 5 generations back · ◆ in the 2010 ancestors bar of FIG. 11 Class I recall
What does this lineage say?
- The line of descent spans 14 years and passes through 5 companies; a new generation was cleared every 8 months on median.
- 22 of the 146 ancestors have a recall of any class; 1 has a Class I recall.
- Of its descendants, K203673 (Medacta International S.A., 2021) has gone furthest, with 3 descendants of its own.
- 1 other device also cites its predicate K162419.
How does its category compare?
All PQC devicesPQC Pedicle Screw Placement Guide: FDA decisions, review times, recalls and adverse event reports over 20 years. 2018, 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: x Pedicle screw’s shank is straight along its longitudinal axis (i.e. not curved) x 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:
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.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K181399 · printed Nov 5, 2026
Cite this page
510(k) Report. “K181399: FIREFLY® Pedicle Screw Navigation Guide.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K181399
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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