# K113366: Leucadia Autolok Pedicle Screw System

- Pathway: 510(k) (Special)
- Applicant: Phygen, LLC
- Decided: Jan 17, 2012 after 63 days
- Product code: NKB (Thoracolumbosacral Pedicle Screw System)
- Device class: 2
- Regulation: 21 CFR 888.3070
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K110588 (2011). 1 ancestor in all.
1 later device descends from it; 1 cites it directly.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K110588: Leucadia Pedicle Screw System, Phygen, LLC (2011). Our reading of the summary gave K110586, FDA’s number for Advia Centaur Vitamin D Total Assay (Siemens Healthcare Diagnostics, Inc.). Corrected to the number one digit away whose FDA name carries the summary’s words for the device, “LEUCADIA TM Pedicle Screw System”.

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

## Recalls of this device
- May 6, 2013 · Class II · Z-1421-2013: Alphatec Spine initiated this medical device recall for the following reason: due to tolerancing, the flange of the Phygen Leucadia" Autolok set screw may interfere with the top of the screw head prio

## Indications for use
The LEUCADIA AutoLok TM Pedicle Screw System is intended to be Used as an adjunct to fusion using autograft or allograft in posterior, non-cervical fixation for the following conditions: Degenerative disc disease (defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies); spondylolisthesis; 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/K113366
Methodology: https://510kreport.com/methodology