# K193506: NuVasive X-Core Expandable VBR System, NuVasive X-Core Mini Cervical Expandable VBR System

- Pathway: 510(k) (Special)
- Applicant: Nu Vasive, Incorporated
- Decided: Feb 26, 2020 after 70 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: 22 generations back to K841189 (1984). 255 ancestors in all.
1 later device descends from it; 1 cites it directly.
1 of 257 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K142205: NuVasive X-CORE (R) Expandable VBR System, Nuvasive, Inc. (2015) Summary page 4.
- K151651: NuVasive X-CORE Mini Cervical Expandable VBR System, Nu Vasive, Incorporated (2015) Summary page 4.
- K192760: NuVasive Modulus XLIF Interbody System, Nu Vasive, Incorporated (2019) Summary page 4.

## Most influential descendants
- K232173: Ascend VBR System, Ascend NanoTec VBR System (2023), 0 descendants of its own

## Indications for use
The NuVasive X-CORE® Expandable 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 X CORE® Expandable 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. The NuVasive X-CORE® Mini Cervical Expandable 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 NuVasive X-CORE® Mini Cervical Expandable 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 NuVasive X-CORE® Mini Cervical Expandable 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/K193506
Methodology: https://510kreport.com/methodology