# K030249: Surgical Titanium Mesh System

- Pathway: 510(k) (Special)
- Applicant: Depuyacromed
- Decided: Feb 14, 2003 after 21 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: 4 generations back to K841189 (1984). 5 ancestors in all.
616 later devices descend from it; 2 cite it directly.
1 of 622 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.
- K020522: Modification to Surgical Titanium Mesh System, Depuyacromed (2002) Summary page 1.

## Most influential descendants
- K080568: X-Mesh Expandable Cage System (2008), 615 descendants of its own
- 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

## Indications for use
The Surgical Titanium Mesh System is indicated for use in the thoracolumbar spine (T I - 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, Monarch and Profile).

Source page: https://510kreport.com/device/K030249
Methodology: https://510kreport.com/methodology