# K023835: Devex Mesh System

- Pathway: 510(k) (Special)
- Applicant: Depuyacromed
- Decided: Jan 29, 2003 after 72 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: 2 generations back to K841189 (1984). 3 ancestors in all.
1,227 later devices descend from it; 7 cite it directly.
1 of 1,231 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K990148: Stackable Cage System, Depuy Motech Acromed (1999) Summary page 1.
- K001340: Stackable Cage System, Depuyacromed (2000) Summary page 1.

## Cited in the summary but kept off the family tree
- K003043: Surgical Titanium Mesh System, Depuyacromed (2001). Not matched in our reading of the summary (scans can blur digits), so it is kept off the family tree
- K000522: Screeners Barbiturate Test, Drugscreen Dip Barbiturate Test, Drug Detection Devices, Ltd. (2000). Not matched in our reading of the summary (scans can blur digits), so it is kept off the family tree

## Most influential descendants
- K030833: Depuy Acromed VBR System (2003), 1,224 descendants of its own
- K031635: Depuy Acromed VBR System (2003), 1,201 descendants of its own
- K041722: Modification to VBR Spinal System (2004), 1,150 descendants of its own
- K052746: Concorde VBR Spinal System (2005), 1,149 descendants of its own
- K081917: Depuy Spine Bengal, Concorde, Cougar, Devex and Leopard Systems (2009), 1,008 descendants of its own

## Indications for use
The Devex Mesh System is indicated for use in the thoracolumbar spine (T1-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 Devex Mesh System is also indicated for treating fractures of the thoracic and lumbar spine. The Devex Mesh 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 Devex Mesh System is intended for use with supplemental internal fixation. The supplemental internal fixation systems that may be used with the Devex Mesh System include DePuy AcroMed titanium plate or rod systems (e.g. Kaneda SR, University Plate, M-2, ISOLA, VSP, Moss Miami, TiMX, Monarch and Profile).

Source page: https://510kreport.com/device/K023835
Methodology: https://510kreport.com/methodology