# K101971: Syntec OS Spinal Fixation System

- Pathway: 510(k) (Traditional)
- Applicant: Syntec Scientific Corp.
- Decided: Mar 25, 2011 after 255 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: 8 generations back to K040583 (2004). 41 ancestors in all.
No later device cites it as a predicate yet.
0 of 42 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K091442: CD Horizon Spinal System, Medtronic Sofamor Danek (2009) Summary page 1.

## Indications for use
Syntec OS Spinal Fixation System is intended to provide immobilization and stabilization of spinal segments in the thoracic, lumbar, and sacral spine as an adjunct to fusion in the treatment of the following: * Degenerative disc disease * Spondylolisthesis * Trauma (i.e., fracture or dislocation) * Spinal stenosis * Deformities or curvatures (i.e., scoliosis, kyphosis, and/or lordosis) * Tumor * Pseudoarthrosis * Faileid previous fusion

Source page: https://510kreport.com/device/K101971
Methodology: https://510kreport.com/methodology