# K190361: Zavation Spinal System

- Pathway: 510(k) (Traditional)
- Applicant: Zavation Medical Products, LLC
- Decided: Mar 18, 2019 after 31 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: 12 generations back to K040583 (2004). 203 ancestors in all.
No later device cites it as a predicate yet.
1 of 204 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K153404: Zavation Spinal System, Zavation, LLC (2016) Summary page 4.

## Indications for use
The Zavation Spinal 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 disc disease (DDD) (defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies); spondylolisthesis; trauma (i.c., fracture or dislocation); spinal stenosis; tumor; pseudoarthrosis; and failed previous fusion.

Source page: https://510kreport.com/device/K190361
Methodology: https://510kreport.com/methodology