# K170266: Palisade™ Pedicular Fixation System

- Pathway: 510(k) (Traditional)
- Applicant: Spineology, Inc.
- Decided: Apr 14, 2017 after 77 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). 333 ancestors in all.
2 later devices descend from it; 1 cites it directly.
1 of 336 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K160980: Threshold Pedicular Fixation System, Palisade Pedicular Fixation System, Spineology, Inc. (2016) Summary page 4.
- K153323: Palisade Pedicular Fixation System, Spineology, Inc. (2016) Summary page 4.
- K123352: S4 Spinal System, Aesculap Implant Systems, Inc. (2012) Summary page 4.
- K162494: CD HORIZON® Spinal System, Medtronic Sofamor Danek USA, Inc. (2016) Summary page 4.
- K152968: Arsenal Spinal Fixation System, Alphatec Spine, Inc. (2015) Summary page 4.
- K120838: Synthes Matrix System, Synthes Spine (2012) Summary page 4.

## Most influential descendants
- K171438: Palisade™ 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 Spineology Palisade™ 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/K170266
Methodology: https://510kreport.com/methodology