# K020522: Modification to Surgical Titanium Mesh System

- Pathway: 510(k) (Special)
- Applicant: Depuyacromed
- Decided: Mar 21, 2002 after 30 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: 3 generations back to K841189 (1984). 4 ancestors in all.
1,234 later devices descend from it; 7 cite it directly.
1 of 1,239 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K003043: Surgical Titanium Mesh System, Depuyacromed (2001) Summary page 1.
- K003709: Surgical Dynamics Mesh Cage System, United States Surgical, A Division of Tyco Healthc (2001) Summary page 1.

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

Source page: https://510kreport.com/device/K020522
Methodology: https://510kreport.com/methodology