# K052210: Nuvasive Coroent Extensure System

- Pathway: 510(k) (Special)
- Applicant: Nuvasive, Inc.
- Decided: Dec 12, 2005 after 119 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: 5 generations back to K010530 (2001). 13 ancestors in all.
263 later devices descend from it; 4 cite it directly.
0 of 277 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K043405: Nuvasive Coroent System, Nuvasive, Inc. (2005). Our reading of the summary gave K043205, FDA’s number for Rusch Easy Tube (Teleflex Medical). Corrected to the number one digit away whose FDA name carries the summary’s words for the device, “NuVasive CoRoent System”.

## Most influential descendants
- K103666: Lanx Lateral (2011), 238 descendants of its own
- K133557: Juliet LL Lateral Lumbar Cage (2014), 147 descendants of its own
- K141135: Juliet LL (2014), 146 descendants of its own
- K161888: JULIET® LL Lateral Lumbar Cage (2016), 145 descendants of its own
- K181644: EIT Cellular Titanium® Lumbar Cage LLIF (2018), 141 descendants of its own

## Indications for use
The NuVasive CoRoent ExtenSure System is a partial vertebral body replacement device indicated for use in the thoracolumbar spine (T1 to L5) to replace a diseased vertebral body resected or excised for the treatment of a collapsed, damaged, or unstable vertebral body(s) due to tumor or trauma 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/K052210
Methodology: https://510kreport.com/methodology