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 · MNI Orthosis, Spinal Pedicle Fixation
Cleared on Feb 8, 2011 as substantially equivalent to K083826 (Allez Spine, LLC, 2009) and 1 other predicate after a 111-day review. Its family tree reaches back 2 generations to 1999. 1 later device descends from it.
- Decided
- Feb 8, 2011
- Review
- 111 days
- Class
- Class II
- Product code
- MNI
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 2 generations to K981676 (1999). 3 ancestors in all. 1 later device descends from it, 1 citing it directly.
- Root · 2 generations backK981676 CD Horizon Spinal SystemSofamor Danek USA,Inc. · 1999
- 1 generation backK050060 Laguna Pedicle Screw SystemAllez Spine, LLC · 2005 · Recalled
- This deviceK103102 Leucadia Pedicle Screw SystemPhygen, LLC · 2011
- Descendant · cites it directly · 0 of its ownK182339 LEUCADIA AUTOLOK™ Pedicle Screw SystemClearview Orthopedic Development, LLC · 2018
Most influential descendants
Showing 1 of 1 · See all- K182339LEUCADIA AUTOLOK™ Pedicle Screw SystemClearview Orthopedic Development, LLC · 2018 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K981676 | CD Horizon Spinal System | Sofamor Danek USA,Inc. | 1999 | — |
| −1 | K050060 | Laguna Pedicle Screw System | Allez Spine, LLC | 2005 | 27 |
| 0 (this device) | K103102 | Leucadia Pedicle Screw System | Phygen, LLC | 2011 | — |
| +1 | K182339 | LEUCADIA AUTOLOK™ Pedicle Screw System | Clearview Orthopedic Development, LLC | 2018 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2009 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2018 | 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 MNI? 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? (2)
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 |
|---|---|---|---|
| * | K083826 | Laguna Polyaxial Pedicle Screw SystemSummary page 1…per ASTM F136. Equivalence: The modified LEUCADIA TM Pedicle Screw System is substantially equivalent to the original LAGUNA@ Pedicle Screw System (K083826 S/E 22 JAN 2009 and K050060 S/E 04 MAY 2005), which is manufactured and marketed by Phygen, LLC… | 2009 |
| * | K050060 | Laguna Pedicle Screw SystemSummary page 1…LEUCADIA TM Pedicle Screw System is substantially equivalent to the original LAGUNA@ Pedicle Screw System (K083826 S/E 22 JAN 2009 and K050060 S/E 04 MAY 2005), which is manufactured and marketed by Phygen, LLC. K1 03102 LEUCADIA TM Pedicle Screw… | 2005 |
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 |
|---|---|---|---|
| K182339 | LEUCADIA AUTOLOK™ Pedicle Screw System | 2018 | 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 12 years and passes through 3 companies; a new generation was cleared every 6.3 years on median.
- 1 of the 3 ancestors has a recall of any class.
- Of its descendants, K182339 (Clearview Orthopedic Development, LLC, 2018) has gone furthest, with 0 descendants of its own.
- 1 other device also cites its predicate K083826.
How does its category compare?
All MNI devicesMNI Orthosis, Spinal Pedicle Fixation: FDA decisions, review times, recalls and adverse event reports over 20 years. 2011, this device’s year, is highlighted.
FDA decisions per year · MNI
1in 2017
2026 to Oct 25, outlined.
Median 510(k) review, days · MNI
168in 2016
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · MNI
1in 2018
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · MNI
80in 2025
MAUDE reports naming product code MNI, 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 | 20 | 82 | 26 | 83 |
| 2008 | 23 | 64 | 8 | 108 |
| 2009 | 18 | 86 | 3 | 138 |
| 2010 | 16 | 74 | 1 | 126 |
| 2011 | 17 | 111 | 0 | 146 |
| 2012 | 19 | 75 | 1 | 200 |
| 2013 | 14 | 77 | 4 | 824 |
| 2014 | 6 | 104 | 0 | 301 |
| 2015 | 12 | 54 | 1 | 260 |
| 2016 | 7 | 168 | 0 | 117 |
| 2017 | 1 | — | 0 | 247 |
| 2018 | 0 | — | 1 | 134 |
| 2019 | 0 | — | 0 | 188 |
| 2020 | 0 | — | 0 | 115 |
| 2021 | 0 | — | 0 | 270 |
| 2022 | 0 | — | 0 | 214 |
| 2023 | 0 | — | 0 | 122 |
| 2024 | 0 | — | 0 | 114 |
| 2025 | 0 | — | 0 | 80 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
The LEUCADIA TM Pedicle Screw System is intended to be used in
skeletally mature patients as an adjunct to fusion using autograft or
allograft in posterior, non-cervical fixation for the following conditions:
severe spondylolisthesis (grade 3 and 4) at L5-S1; degenerative
spondylolisthesis with objective evidence of neurologic impairment;
trauma (i.e. fracture or dislocation); spinal stenosis; curvatures (i.e.
scoliosis, kyphosis and/or lordosis); tumor; pseudarthrosis; and/or failed
previous fusion.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K103102 · printed Nov 6, 2026
Cite this page
510(k) Report. “K103102: 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/K103102
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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