# K180458: FOCUS Pedicle Screw System

- Pathway: 510(k) (Traditional)
- Applicant: Nvision Biomedical Technologies, LLC
- Decided: Apr 17, 2018 after 56 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: 17 generations back to K040583 (2004). 182 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 184 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K161363: Arsenal Spinal Fixation System, Alphatec Spine, Inc. (2016) Summary page 5.
- K101278: Inertia Pedicle Screw System, Nexxt Spine, LLC (2010) Summary page 5.

## Most influential descendants
- K200937: ACURA Stabilization System (2020), 0 descendants of its own

## Indications for use
The FOCUS Pedicle Screw System is intended for use in the non-cervical posterior spine (T1 to S1) 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: degenerative disc disease (defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies), spondylolisthesis, fracture, dislocation, deformities or curvatures (i.e., scoliosis, kyphosis, and/or lordosis), spinal stenosis, tumor, pseudarthrosis, and failed previous fusion.

Source page: https://510kreport.com/device/K180458
Methodology: https://510kreport.com/methodology