# K253158: VyBrate™ VBR System

- Pathway: 510(k) (Traditional)
- Applicant: Vy Spine, LLC
- Decided: Jan 7, 2026 after 103 days
- Product code: MQP (Spinal Vertebral Body Replacement Device)
- Device class: 2
- Regulation: 21 CFR 888.3060
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 14 generations back to K003155 (2001). 56 ancestors in all.
No later device cites it as a predicate yet.
0 of 57 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K142005: SpineFab Vertebral Body Replacement (VBR) System, Oxford Performance Materials (2015) Summary page 5.
- K180550: NuVasive Monolith Cervical Corpectomy System, Nu Vasive, Incorporated (2018) Summary page 5.

## Indications for use
The VyBrate-L™ VBR System is intended for use in the thoracolumbar spine (T1‐L5) to replace a collapsed, damaged, or unstable vertebral body due to tumor or trauma (i.e. fracture). The VyBrate-L™ VBR device is intended for use with autograft and/or allograft bone graft material and must be used with supplemental fixation systems. The VyBrate-C™ VBR System is a vertebral body replacement device indicated for use in the cervical spine (C3-C7 vertebral bodies) in skeletally mature patients to replace a diseased or damaged vertebral body caused by tumor, fracture, or osteomyelitis, or for reconstruction following corpectomy performed to achieve decompression of the spinal cord and neural tissues in cervical degenerative disorders. The VyBrate-C™ VBR System is intended to be used with supplemental fixation cleared by the FDA for use in the cervical spine. These implants are intended for use with autograft or allogenic bone graft comprised of cancellous and/or corticocancellous bone graft, as an adjunct to fusion. The VyBrate-C™ VBR System is also 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 cervical spine in whom life expectancy is of insufficient duration to permit achievement of fusion, with bone graft used at the surgeon’s discretion.

Source page: https://510kreport.com/device/K253158
Methodology: https://510kreport.com/methodology