# K140563: Lateral VBR System

- Pathway: 510(k) (Traditional)
- Applicant: Nu Vasive, Incorporated
- Decided: Aug 7, 2014 after 155 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: 11 generations back to K003155 (2001). 62 ancestors in all.
No later device cites it as a predicate yet.
0 of 63 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K032476: Nuvasive Mesh, Nuvasive, Inc. (2003) Summary page 4.
- K052670: Staxx XD System, Spine Wave, Inc. (2006) Summary page 4.
- K090315: Staxx XD System, Spine Wave, Inc. (2009) Summary page 4.
- K102315: Staxx XDL System, Spine Wave, Inc. (2011) Summary page 4.
- K012254: VBR, Osteotech, Inc. (2001) Summary page 4.
- K071795: Nuvasive Coroent System, Nuvasive, Inc. (2007) Summary page 4.
- K083186: Aesculap Hydrolift VBR System, Aesculap Implant System, Inc. (2010) Summary page 4.

## Indications for use
The NuVasive® Lateral VBR System is a partial or total vertebral body replacement device indicated for use in the thoracolumbar spine (T1 to LS5) to replace a diseased or damaged vertebral body caused by tumor or fracture, to restore height of a collapsed vertebral body, and to achieve decompression of the spinal cord and neural tissues. The System is intended to be used with supplemental internal spinal fixation systems that are cleared by the FDA for use in the thoracic and lumbar spine. Allograft or autograft material may be used at the surgeon's discretion.

Source page: https://510kreport.com/device/K140563
Methodology: https://510kreport.com/methodology