510(k) · Cleared
ClearedLeucadia Pedicle Screw System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Phygen, LLC · NKB Thoracolumbosacral Pedicle Screw System
Cleared on May 25, 2011 after an 84-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 4 later devices descend from it.
- Decided
- May 25, 2011
- Review
- 84 days
- Class
- Class II
- Product code
- NKB
- Recalls
- None
- Predicates
- 0
4 later devices descend from it, 4 citing it directly.
- This deviceK110588 Leucadia Pedicle Screw SystemPhygen, LLC · 2011
- Descendant · cites it directly · 1 of its ownK113366 Leucadia Autolok Pedicle Screw SystemPhygen, LLC · 2012 · Recalled
- Descendant · cites it directly · 0 of its ownK182339 LEUCADIA AUTOLOK™ Pedicle Screw SystemClearview Orthopedic Development, LLC · 2018
- Descendant · cites it directly · 0 of its ownK120355 Leucadia 4.5 MM Pedicle Screw SystemPhygen, LLC · 2012
- Descendant · cites it directly · 0 of its ownK112931 Leucadia (TM) Mis Pedicle Screw SystemPhygen, LLC · 2011
Most influential descendants
Showing 4 of 4 · See all- K113366Leucadia Autolok Pedicle Screw SystemPhygen, LLC · 2012 · cites it directly1descendant
- K182339LEUCADIA AUTOLOK™ Pedicle Screw SystemClearview Orthopedic Development, LLC · 2018 · cites it directly0descendants
- K120355Leucadia 4.5 MM Pedicle Screw SystemPhygen, LLC · 2012 · cites it directly0descendants
- K112931Leucadia (TM) Mis Pedicle Screw SystemPhygen, LLC · 2011 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K110588 | Leucadia Pedicle Screw System | Phygen, LLC | 2011 | — |
| +1 | K113366 | Leucadia Autolok Pedicle Screw System | Phygen, LLC | 2012 | 1 |
| +1 | K182339 | LEUCADIA AUTOLOK™ Pedicle Screw System | Clearview Orthopedic Development, LLC | 2018 | — |
| +1 | K120355 | Leucadia 4.5 MM Pedicle Screw System | Phygen, LLC | 2012 | — |
| +1 | K112931 | Leucadia (TM) Mis Pedicle Screw System | Phygen, LLC | 2011 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2011 | 1 | 0 |
| 2012 | 2 | 0 |
| 2018 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in NKB? 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 NKB device
- #1 K223494 CD Horizon Spinal Systemscore 40.4 · 30 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against?
FDA has not posted a summary or statement for it, so its predicates are not known.
What descends from it? (4)
4 later devices cite it directly; ranked here by how many devices descend from each in turn.
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?
- Of its descendants, K113366 (Phygen, LLC, 2012) has gone furthest, with 1 descendant of its own.
How does its category compare?
All NKB devicesNKB Thoracolumbosacral Pedicle Screw System: FDA decisions, review times, recalls and adverse event reports over 20 years. 2011, this device’s year, is highlighted.
FDA decisions per year · NKB
24in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · NKB
61in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · NKB
1in 2025
Class I (1 since 2007) Class II/III not classified
Adverse event reports per year · NKB
1,171in 2025
MAUDE reports naming product code NKB, 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 | 38 | 87 | 4 | 34 |
| 2008 | 36 | 59 | 5 | 82 |
| 2009 | 44 | 71 | 33 | 171 |
| 2010 | 37 | 111 | 4 | 462 |
| 2011 | 48 | 84 | 3 | 577 |
| 2012 | 60 | 79 | 13 | 1,747 |
| 2013 | 35 | 73 | 0 | 1,962 |
| 2014 | 46 | 90 | 3 (1) | 1,671 |
| 2015 | 55 | 90 | 3 | 1,446 |
| 2016 | 50 | 84 | 1 | 1,585 |
| 2017 | 63 | 69 | 1 | 1,618 |
| 2018 | 56 | 61 | 3 | 1,684 |
| 2019 | 39 | 84 | 1 | 1,915 |
| 2020 | 48 | 68 | 1 | 2,076 |
| 2021 | 32 | 61 | 0 | 1,745 |
| 2022 | 34 | 88 | 5 | 1,339 |
| 2023 | 44 | 72 | 2 | 919 |
| 2024 | 39 | 57 | 3 | 1,614 |
| 2025 | 24 | 61 | 1 | 1,171 |
| 2026 | 30 | 91 | 3 | — |
https://510kreport.com/device/K110588 · printed Nov 6, 2026
Cite this page
510(k) Report. “K110588: Leucadia 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/K110588
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Record history
- FDA decision record loaded May 2, 2026
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026