# K090176: Nuvasive Adjustable Vertebral Body Replacement System

- Pathway: 510(k) (Special)
- Applicant: Nuvasive, Inc.
- Decided: Apr 27, 2009 after 94 days
- Product code: MQP (Spinal Vertebral Body Replacement Device)
- Device class: 2
- Regulation: 21 CFR 888.3060
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
75 later devices descend from it; 1 cites it directly.
0 of 76 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names its predicate without a number.
- (no number) NuVasive Mesh System: named in the summary without a submission number

## Most influential descendants
- K142205: NuVasive X-CORE (R) Expandable VBR System (2015), 74 descendants of its own
- K151651: NuVasive X-CORE Mini Cervical Expandable VBR System (2015), 68 descendants of its own
- K152568: C-VBR (2016), 57 descendants of its own
- K162315: FORTIFY Corpectomy Spacers (2017), 55 descendants of its own
- K172032: Modulift Vertebral Body Replacement (VBR) System (2017), 46 descendants of its own

## Recalls of this device
- Nov 10, 2022 · Class II · Z-0738-2023: Potential that insert will be unable to disengage from the vertebral body replacement device/implant

## Indications for use
The NuVasive Adjustable VBR System is a vertebral body replacement device indicated for use in the thoracolumbar spine (T1 to L5) 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 NuVasive Adjustable VBR 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/K090176
Methodology: https://510kreport.com/methodology