# K172107: Threshold™ V2 Pedicular Fixation System, Threshold™ Pedicular Fixation System, Fortress™ Pedicular Fixation System, Palisade™ Pedicular Fixation System

- Pathway: 510(k) (Traditional)
- Applicant: Spineology, Inc.
- Decided: Aug 21, 2017 after 40 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: 21 generations back to K040583 (2004). 363 ancestors in all.
No later device cites it as a predicate yet.
1 of 364 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K170255: Threshold™ V2 Pedicular Fixation System, Spineology, Inc. (2017) Summary page 4.
- K170251: Threshold™ Pedicular Fixation System, Spineology, Inc. (2017) Summary page 4.
- K170268: Fortress™ Pedicular Fixation System, Spineology, Inc. (2017) Summary page 4.
- K171438: Palisade™ Pedicular Fixation System, Spineology, Inc. (2017) Summary page 4.
- K120838: Synthes Matrix System, Synthes Spine (2012) Summary page 4.
- K111478: Stryker Spine Power Adaptor (Accessory Instrument), Stryker Corporation (2011) Summary page 4.

## Indications for use
Spineology Pedicular Fixation Systems are 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/K172107
Methodology: https://510kreport.com/methodology