# K140010: Fortress Pedicle Screw System

- Pathway: 510(k) (Traditional)
- Applicant: Spineology, Inc.
- Decided: Apr 23, 2014 after 111 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: 15 generations back to K040583 (2004). 113 ancestors in all.
11 later devices descend from it; 5 cite it directly.
0 of 125 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K082509: Eos Spinal System, Korea Bone Bank Co., Ltd. (2008) Summary page 1.
- K132471: CD Horizon Spinal System, Medtronic Sofamor Danek USA, Inc. (2013) Summary page 1.

## Most influential descendants
- K152148: Fortress Pedicular Fixation System (2015), 8 descendants of its own
- K143403: Threshold Pedicular Fixation System (2014), 8 descendants of its own
- 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

## Indications for use
The Spineology Fortressm Pedicle Screw System is intended for posterior, nan-cervical fixation as an adjunct to fusion 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; cuvatures (i.e., scoliosis, kyphosis and/or lordosis); tumor; pseudoarthrosis; and/or failed previous fusion.

Source page: https://510kreport.com/device/K140010
Methodology: https://510kreport.com/methodology