# K103102: Leucadia Pedicle Screw System

- Pathway: 510(k) (Special)
- Applicant: Phygen, LLC
- Decided: Feb 8, 2011 after 111 days
- Product code: MNI (Orthosis, Spinal Pedicle Fixation)
- Device class: 2
- Regulation: 21 CFR 888.3070
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 2 generations back to K981676 (1999). 3 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 5 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K083826: Laguna Polyaxial Pedicle Screw System, Allez Spine, LLC (2009) Summary page 1.
- K050060: Laguna Pedicle Screw System, Allez Spine, LLC (2005) Summary page 1.

## Most influential descendants
- K182339: LEUCADIA AUTOLOK™ Pedicle Screw System (2018), 0 descendants of its own

## Indications for use
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.

Source page: https://510kreport.com/device/K103102
Methodology: https://510kreport.com/methodology