# K230974: NIDO™ Pedicle Screw System

- Pathway: 510(k) (Traditional)
- Applicant: Kalitec Medical
- Decided: Sep 15, 2023 after 163 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: 10 generations back to K950697 (1995). 111 ancestors in all.
No later device cites it as a predicate yet.
0 of 112 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K172808: CosmoLock Pedicle Screw System, Kalitec Direct, LLC (2017) Summary page 4.
- K140678: Cosmolock Pedicle Screw System, Kalitec Direct, LLC (2014) Summary page 4.

## Indications for use
The NIDO™ Pedicle Screw System is 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 thoracic, lumbar, and sacral spine: degenerative spondylolisthesis with objective evidence of neurological impairment, fracture, dislocation, deformities or curvatures (i.e. scoliosis, kyphosis, and/or lordosis), spinal tumor, pseudarthrosis and failed previous fusion. The NIDO™ Pedicle Screw System is also intended for non-cervical pedicle screw fixation for the following indications: severe spondylolisthesis (grades 3 and 4) of the L5-S1 vertebra in skeletally mature patients receiving fusion by autogenous bone graft having implants attached to the lumbar and sacral spine (L3 to sacrum) with removal of the implants after the attainment of a solid fusion. It is also intended for the following indications: trauma (i.e. fracture or dislocation); spinal stenosis; deformities or curvatures (i.e. scoliosis, kyphosis, and/or lordosis), tumor; pseudoarthrosis; and failed previous fusion. The NIDO™ Pedicle Screw System Cannulated/Fenestrated Screws are intended to be used with saline and radiopaque dye.

Source page: https://510kreport.com/device/K230974
Methodology: https://510kreport.com/methodology