# K223529: PressON Spinal Fixation System

- Pathway: 510(k) (Traditional)
- Applicant: Nexus Spine, LLC
- Decided: May 2, 2023 after 160 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.
1 later device descends from it; 1 cites it directly.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The summary cites one number, which could not be confirmed as its predicate (listed below).

## Cited in the summary but kept off the family tree
- K160820: PressON Pro Spinal Fixation System, Nexus Spine, LLC (2016). Not matched in our reading of the summary (scans can blur digits), so it is kept off the family tree

## Most influential descendants
- K253331: PressON Spinal Fixation System (2025), 0 descendants of its own

## Indications for use
The PressON 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/K223529
Methodology: https://510kreport.com/methodology