# K193211: Nano FortiFix® System

- Pathway: 510(k) (Traditional)
- Applicant: Nanovis Spine, LLC
- Decided: Mar 20, 2020 after 120 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: 16 generations back to K853033 (1985). 225 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 227 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K113173: Nanovis Spinal System, Nanovis, LLC (2012) Summary page 4.
- K133369: Tiger Spine System, Corelink, LLC (2014) Summary page 4.

## Most influential descendants
- K203452: Nano FortiFix® System (2020), 0 descendants of its own

## Indications for use
The Nano FortiFix® System is intended to provide immobilization and stabilization of spinal segments in skeletally mature patients as an adjunct to fusion in the non-cervical spine for the following indications: DDD (defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies), spinal stenosis, spondylolisthesis, spinal deformities (i.e., scoliosis, kyphosis, and/ or lordosis), trauma (i.e., fracture or dislocation), tumor, pseudarthrosis and/or failed previous fusion.

Source page: https://510kreport.com/device/K193211
Methodology: https://510kreport.com/methodology