# K260286: Dynamo™ Spinal Cement; Salvo® Spine System

- Pathway: 510(k) (Traditional)
- Applicant: Spine Wave, Inc.
- Decided: Jun 15, 2026 after 137 days
- Product code: PML (Bone Cement, Posterior Screw Augmentation)
- Device class: 2
- Regulation: 21 CFR 888.3027
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 22 generations back to K853033 (1985). 293 ancestors in all.
No later device cites it as a predicate yet.
1 of 294 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K241034: Meta+ Bone Cement & M.U.S.T. Fenestrated Pedicle Screw System, Medacta International S.A. (2024) Summary page 5.
- K240685: Salvo® Spine System, Spine Wave, Inc. (2024) Summary page 5.

## 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). When used in a percutaneous approach with minimally invasive surgery (MIS) instrumentation, 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). When the Salvo® Spine System fenestrated screws are used in conjunction with Dynamo TM Spinal Cements (MV or HV), the Salvo® Spine System is intended to restore the integrity of the spinal column even in the absence of fusion for a limited time period in patients with advanced stage tumors involving the thoracic and lumbar spine in whom life expectancy is of insufficient duration to permit achievement of fusion. The Salvo® fenestrated screws augmented with the Dynamo TM Spinal Cements (MV or HV) are for use at spinal levels where the structural integrity of the spine is not severely compromised. Dynamo TM Spinal Cements (MV or HV), when used in conjunction with the Salvo® Spine System fenestrated screws, are intended to restore the integrity of the spinal column even in the absence of fusion for a limited time period in patients with advanced stage tumors involving the thoracic and lumbar spine, in whom life expectancy is of insufficient duration to allow for achievement of fusion. Dynamo TM Spinal Cements (MV or HV) are limited for use at spinal levels where the structural integrity of the spine is not severely compromised.

Source page: https://510kreport.com/device/K260286
Methodology: https://510kreport.com/methodology