510(k) · Cleared
ClearedGalleon Pedicle Screw System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Everest Spine, LLC · MNH Orthosis, Spondylolisthesis Spinal Fixation
Cleared on Dec 3, 2012 as substantially equivalent to K091110 (Spinal Edge, LLC, 2009) after an 81-day review. Its family tree reaches back 5 generations to 1995.
- Decided
- Dec 3, 2012
- Review
- 81 days
- Class
- Class II
- Product code
- MNH
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 5 generations to K944736 (1995). 27 ancestors in all, the oldest K933881 (1994). No later device cites it as a predicate yet.
- Root · 5 generations backK944736 VSP (Variable Screw Placement)Acromed Corp. · 1995
- 4 generations backK981274 Acromed Timx Plate Based Low Back SystemAcromed Corp. · 1998
- 3 generations backK010576 Monarch Spine SystemDepuyacromed · 2001
- 2 generations backK023438 Modification to Monarch Spine SystemDepuyacromed · 2002
- 1 generation backK091110 Spinal Edge Titan Pedicle Screw SystemSpinal Edge, LLC · 2009
- This deviceK122814 Galleon Pedicle Screw SystemEverest Spine, LLC · 2012
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −5 | K944736 | VSP (Variable Screw Placement) | Acromed Corp. | 1995 | — |
| −4 | K981274 | Acromed Timx Plate Based Low Back System | Acromed Corp. | 1998 | — |
| −3 | K010576 | Monarch Spine System | Depuyacromed | 2001 | — |
| −2 | K023438 | Modification to Monarch Spine System | Depuyacromed | 2002 | — |
| −1 | K091110 | Spinal Edge Titan Pedicle Screw System | Spinal Edge, LLC | 2009 | — |
| 0 (this device) | K122814 | Galleon Pedicle Screw System | Everest Spine, LLC | 2012 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1994 | 1 | 0 |
| 1995 | 3 | 0 |
| 1996 | 4 | 0 |
| 1997 | 1 | 0 |
| 1998 | 6 | 0 |
| 1999 | 2 | 0 |
| 2001 | 2 | 0 |
| 2002 | 1 | 0 |
| 2003 | 2 | 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 MNH? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
- Candidate predicates for a device like this, rankedin the report
- Recall history across each candidate’s familyin 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 |
|---|---|---|---|
| * | K091110 | Spinal Edge Titan Pedicle Screw SystemSummary page 1…(21 CER 888.3070), Class 11 Product Codes MNH, MNI 3. Predicate Devices K091 110 Spinal Edge Titan Pedicle Screw System 4. Device Description The Everest Spine Galleon Pedicle Screw System co… | 2009 |
What descends from it?
No later submission names this one as a predicate yet.
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 17 years and passes through 4 companies; a new generation was cleared every 3.1 years on median.
- None of the 27 ancestors has a recall.
How does its category compare?
All MNH devicesMNH Orthosis, Spondylolisthesis Spinal Fixation: FDA decisions, review times, recalls and adverse event reports over 20 years. 2012, this device’s year, is highlighted.
FDA decisions per year · MNH
8in 2016
2026 to Oct 25, outlined.
Median 510(k) review, days · MNH
93in 2016
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · MNH
1in 2016
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · MNH
89in 2025
MAUDE reports naming product code MNH, 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 | 5 | 123 | 0 | 18 |
| 2008 | 13 | 65 | 0 | 30 |
| 2009 | 13 | 151 | 7 | 45 |
| 2010 | 10 | 106 | 0 | 59 |
| 2011 | 17 | 171 | 0 | 107 |
| 2012 | 7 | 93 | 1 | 433 |
| 2013 | 10 | 124 | 1 | 464 |
| 2014 | 12 | 140 | 0 | 286 |
| 2015 | 10 | 99 | 0 | 152 |
| 2016 | 8 | 93 | 1 | 216 |
| 2017 | 0 | — | 0 | 174 |
| 2018 | 0 | — | 0 | 129 |
| 2019 | 0 | — | 0 | 403 |
| 2020 | 0 | — | 0 | 432 |
| 2021 | 0 | — | 0 | 531 |
| 2022 | 0 | — | 0 | 265 |
| 2023 | 0 | — | 0 | 121 |
| 2024 | 0 | — | 0 | 302 |
| 2025 | 0 | — | 0 | 89 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
The Everest Spine Galleon Pedicle Screw System is intended for posterior, noncervical pedicle fixation for the following indications: severe spondylolisthesis (grade 3 or 4) of the L5-SI vertebrae;,trauma (i.e. fracture or dislocation), spinal stenosis, curvatures (i.e. scoliosis, kyphosis, and/or lordosis); tumor; pseudoarthrosis; and failed previous fusion. The device is to be used in skeletally mature patients, and for stabilization and immobilization of the spine as an adjunct to ifusion with bone graft. The levels of fixation are T8- SI.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K122814 · printed Nov 6, 2026
Cite this page
510(k) Report. “K122814: Galleon Pedicle Screw System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K122814
Report an extraction error
Are you the manufacturer?
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