# K182954: Salvo™ Spine System

- Pathway: 510(k) (Traditional)
- Applicant: Spine Wave, Inc.
- Decided: Dec 12, 2018 after 49 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). 218 ancestors in all.
6 later devices descend from it; 1 cites it directly.
1 of 225 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K172594: Proficient® Posterior Cervical Spine System, Spine Wave, Inc. (2017) Summary page 4.
- K160003: Sniper (R) Spine System, Spine Wave, Inc. (2016) Summary page 4.
- K180210: CREO® Stabilization System, Globus Medical, Inc. (2018) Summary page 4.

## Most influential descendants
- K191045: Salvo™ Spine System (2019), 5 descendants of its own
- K202476: Salvo® Spine System (2020), 4 descendants of its own
- K222362: Salvo® Spine System (2022), 3 descendants of its own
- K240685: Salvo® Spine System (2024), 2 descendants of its own
- K260286: Dynamo™ Spinal Cement; Salvo® Spine System (2026), 0 descendants of its own

## Indications for use
The Salvo™ Spine 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 the thoracic, lumbar, and sacral spine: degenerative disc disease; spondylolisthesis; fracture; dislocation; scoliosis; kyphosis; spinal tumor; and failed previous fusion (pseudarthrosis).

Source page: https://510kreport.com/device/K182954
Methodology: https://510kreport.com/methodology