# K181554: Stowe Pedicle Screw System

- Pathway: 510(k) (Special)
- Applicant: Black Box Medical
- Decided: Jul 27, 2018 after 44 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: 1 generation back to K071824 (2007). 1 ancestor in all.
1 later device descends from it; 1 cites it directly.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K071824: Acme Talon Pedicle Screw, Acme Spine, LLC (2007) Summary page 4.

## Most influential descendants
- K201751: Pedicle Screw System (2020), 0 descendants of its own

## Indications for use
The Stowe Pedicle Screw System is intended to provide immobilization and stabilization of spinal segments in skeletally mature patients as an adjunct to fusion in the treatment of the following acute and chronic instabilities or deformities of thoracic, lumbar, and sacral spine: degenerative disc disease (DDD) (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; tumor; pseudoarthrosis; and failed previous fusion.

Source page: https://510kreport.com/device/K181554
Methodology: https://510kreport.com/methodology