# K043405: Nuvasive Coroent System

- Pathway: 510(k) (Traditional)
- Applicant: Nuvasive, Inc.
- Decided: Feb 7, 2005 after 59 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
Longest line of descent: 4 generations back to K010530 (2001). 12 ancestors in all.
712 later devices descend from it; 4 cite it directly.
0 of 725 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K033517: Spinal Concepts Inc. Cadence and Traxis, Spinal Concepts, Inc. (2004) Summary page 2.
- K011037: Vertebral Spacer, Synthes (Usa) (2002)
- K032476: Nuvasive Mesh, Nuvasive, Inc. (2003) Summary page 2.
- K041939: Blackstone Peek Vertebral Body Replacement System Lordotic Lateral Spacers, Blackstone Medical, Inc. (2004) Summary page 2.

## Most influential descendants
- K051454: Aleutian Spacer System (2005), 666 descendants of its own
- K063399: Aleutian Spacer System (2007), 663 descendants of its own
- K082698: Aleutian Ibf System (2009), 662 descendants of its own
- K101302: Aleutian Ibf System (2010), 595 descendants of its own
- K110843: Aleutian Spacer System (2011), 589 descendants of its own

## Recalls of this device
- Feb 1, 2010 · Not classified · Z-2356-2010: Defects include, but not limited to: Not sterile, not properly labeled, drugs and swabs may be ineffective, and catheter tips may break in patients.

## Indications for use
The NuVasive CoRoent 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/K043405
Methodology: https://510kreport.com/methodology