# K143403: Threshold Pedicular Fixation System

- Pathway: 510(k) (Special)
- Applicant: Spineology, Inc.
- Decided: Dec 18, 2014 after 20 days
- Product code: NKB (Thoracolumbosacral Pedicle Screw System)
- 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: 16 generations back to K040583 (2004). 114 ancestors in all.
8 later devices descend from it; 5 cite it directly.
0 of 123 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K140010: Fortress Pedicle Screw System, Spineology, Inc. (2014) Summary page 4.

## Most influential descendants
- K153323: Palisade Pedicular Fixation System (2016), 7 descendants of its own
- K160980: Threshold Pedicular Fixation System, Palisade Pedicular Fixation System (2016), 6 descendants of its own
- K161694: Threshold™ Pedicular Fixation System (2016), 3 descendants of its own
- K170266: Palisade™ Pedicular Fixation System (2017), 2 descendants of its own
- K171438: Palisade™ Pedicular Fixation System (2017), 1 descendant of its own

## Indications for use
The Spineology Threshold™ Pedicular Fixation System is intended for posterior, non-cervical fixation as an adjunct to fusion in skeletally mature patients for the following indications: 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; pseudoarthrosis; and/or failed previous fusion.

Source page: https://510kreport.com/device/K143403
Methodology: https://510kreport.com/methodology