# K160820: PressON Pro Spinal Fixation System

- Pathway: 510(k) (Traditional)
- Applicant: Nexus Spine, LLC
- Decided: Jun 28, 2016 after 96 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: 7 generations back to K040583 (2004). 32 ancestors in all.
No later device cites it as a predicate yet.
0 of 33 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K133287: Presson Spinal Fixation System, Nexus Spine, LLC (2014) Summary page 5.
- K103490: Expedium Spine System, Moss Miami Spine System, Johnson & Johnson (2011) Summary page 5.
- K090477: Alpine Pedicle Screw System, Sanacor (2009) Summary page 5.

## Indications for use
The PressON Pro Spinal Fixation System is a posterior, non-cervical pedicle screw system 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 the thoracic, lumbar, and sacral spine: degenerative disc disease (defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies), spondylolisthesis, fracture, dislocation, scoliosis, kyphosis, lordosis, spinal tumor, and failed previous fusion (pseudarthrosis).

Source page: https://510kreport.com/device/K160820
Methodology: https://510kreport.com/methodology