# K142205: NuVasive X-CORE (R) Expandable VBR System

- Pathway: 510(k) (Traditional)
- Applicant: Nuvasive, Inc.
- Decided: Feb 20, 2015 after 193 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: 4 generations back to K841189 (1984). 9 ancestors in all.
74 later devices descend from it; 8 cite it directly.
0 of 84 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K090176: Nuvasive Adjustable Vertebral Body Replacement System, Nuvasive, Inc. (2009) Summary page 4.
- K032476: Nuvasive Mesh, Nuvasive, Inc. (2003) Summary page 4.
- K012254: VBR, Osteotech, Inc. (2001) Summary page 4.
- K003836: Synthes Synex Spacer System, Synthes (2001) Summary page 4.
- K061891: Synex II, Synthes Spine Co.Lp (2006) Summary page 4.

## Cited in the summary but kept off the family tree
- K030349: Healthometer Professional Body Fat Monitor and Scale, Models BFM 940, BFM 945 & BFM 960, Bonso Electronics International, Inc. (2003). Our reading of the summary gave K030349, FDA’s number for Healthometer Professional Body Fat Monitor and Scale… (Bonso Electronics International, Inc.). Its FDA name has none of the distinctive words the summary uses for the device it names, “DePuy Surgical Titanium Mesh System”. Kept off the family tree. Summary page 4.

## Most influential descendants
- 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
- K181328: T2 STRATOSPHERE™ Expandable Corpectomy System (2018), 28 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.

Source page: https://510kreport.com/device/K142205
Methodology: https://510kreport.com/methodology