# K161694: Threshold™ Pedicular Fixation System

- Pathway: 510(k) (Special)
- Applicant: Spineology, Inc.
- Decided: Jul 15, 2016 after 25 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: 19 generations back to K040583 (2004). 192 ancestors in all.
3 later devices descend from it; 2 cite it directly.
0 of 196 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K143403: Threshold Pedicular Fixation System, Spineology, Inc. (2014) Summary page 4.
- K140010: Fortress Pedicle Screw System, Spineology, Inc. (2014) Summary page 4.
- K160980: Threshold Pedicular Fixation System, Palisade Pedicular Fixation System, Spineology, Inc. (2016) Summary page 4.
- K152148: Fortress Pedicular Fixation System, Spineology, Inc. (2015) Summary page 4.

## Most influential descendants
- K170255: Threshold™ V2 Pedicular Fixation System (2017), 1 descendant of its own
- K170251: Threshold™ Pedicular Fixation System (2017), 1 descendant of its own
- K172107: Threshold™ V2 Pedicular Fixation System, Threshold™ Pedicular Fixation System, Fortress™ Pedicular Fixation System, Palisade™ Pedicular Fixation System (2017), 0 descendants of its own

## Indications for use
The 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/K161694
Methodology: https://510kreport.com/methodology