# K160986: Xenco Medical Pedicle Screw System

- Pathway: 510(k) (Special)
- Applicant: Xenco Medical, LLC
- Decided: May 4, 2016 after 26 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
No predicates in its family tree.
No later device cites it as a predicate yet.
0 of 1 device in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA’s file for it is a 510(k) statement, which names no predicate.

## Indications for use
The Xenco Medical Pedicle Screw System is intended to provide immobilization and stabilization of spinal segments in skeletally mature patients as an adjunct to fusion. The Xenco Medical Screw System is intended for posterior, non-cervical pedicle fixation or anterolateral fixation for the following indications: degenerative disc disease (DDD) (defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies); curvatures (i.e., scoliosis, kyphosis, or lordosis); spondylolisthesis; trauma (i.e., fracture or dislocation); spinal stenosis; tumor; pseudoarthrosis; and failed previous fusion.

Source page: https://510kreport.com/device/K160986
Methodology: https://510kreport.com/methodology