# K080568: X-Mesh Expandable Cage System

- Pathway: 510(k) (Special)
- Applicant: Depuy Spine, Inc.
- Decided: May 1, 2008 after 62 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 K841189 (1984). 8 ancestors in all.
615 later devices descend from it; 5 cite it directly.
1 of 624 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K030249: Surgical Titanium Mesh System, Depuyacromed (2003) Summary page 1.
- K013382: Modification to: Stackable Cage System, Depuyacromed (2001) Summary page 1.

## Most influential descendants
- K113348: Cougar System (2011), 591 descendants of its own
- K140319: Coroent TI-C System (2014), 590 descendants of its own
- K141665: NuVasive CoRoent System (2015), 588 descendants of its own
- K151472: NuVasive CoRoent Lumbar System (2015), 479 descendants of its own
- K150994: NuVasive CoRoent Thoracolumbar Implants (2015), 402 descendants of its own

## Indications for use
The X-MESHTM Expandable Cage System is indicated for use in the thoracolumbar spine (i.e., TI to L5) to replace a diseased vertebral body resected or excised for the treatment of tumors, to achieve anterior decompression of the spinal cord and neural tissues, and to restore the height of a collapsed vertebral body. The X-MESHTM Expandable Cage System is also indicated for treating fractures of the thoracic and lumbar spine. The X-MESH TM Expandable Cage System is designed to restore the biomechanical integrity of the anterior, middle and posterior spinal column even in the absence of fusion for a prolonged period. The X-MESH TM Expandable Cage System is intended for use with supplemental internal fixation. The supplemental internal fixation systems that may be used include titanium plate or rod systems (i.e., KANEDA TM SR, UNIVERSITY PLATE T M , M-2 ANTERIOR PLATE T M , ISOLA®, VSP®, MOSS®MIAMI, TiMX TM , MONARCHTM EXPEDIUM T M , VIPER TM , and PROFILE TM ).

Source page: https://510kreport.com/device/K080568
Methodology: https://510kreport.com/methodology