# K203452: Nano FortiFix® System

- Pathway: 510(k) (Special)
- Applicant: Nanovis, LLC
- Decided: Dec 22, 2020 after 29 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 K853033 (1985). 240 ancestors in all.
No later device cites it as a predicate yet.
0 of 241 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K193211: Nano FortiFix® System, Nanovis Spine, LLC (2020) Summary page 4.
- K113173: Nanovis Spinal System, Nanovis, LLC (2012) Summary page 4.
- K181339: Altus Spine Pedicle Screw System, Altus Partners, LLC (2018) Summary page 4.

## 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: degenerative disc disease, 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. The Nano FortiFix® System can be used in an open approach or a percutaneous approach with MIS instrumentation.

Source page: https://510kreport.com/device/K203452
Methodology: https://510kreport.com/methodology