# K003043: Surgical Titanium Mesh System

- Pathway: 510(k) (Traditional)
- Applicant: Depuyacromed
- Decided: May 8, 2001 after 221 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). 2 ancestors in all.
1,819 later devices descend from it; 26 cite it directly.
2 of 1,822 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K990148: Stackable Cage System, Depuy Motech Acromed (1999) Summary page 1.
- K841189: Oec/Rezaian Spinal Fixator, Orthopedic Equipment Co., Inc. (1984) Summary page 1.

## Most influential descendants
- K022793: Tetris Spinal Implant (2003), 1,705 descendants of its own
- K031757: Peek Tetris Spinal Implant (2003), 1,702 descendants of its own
- K041888: Curved Peek Tetris Spinal Implant (2004), 1,586 descendants of its own
- K042930: Spacevision Cage System (2004), 1,440 descendants of its own
- K062759: Paramount VBR System (2007), 1,406 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 Bone graft material is recommended to be packed inside of the mesh cage prior to implantation 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 eg Kaneda SR University Plate M 2 ISOLA VSP Moss Miami TiMX and Profile

Source page: https://510kreport.com/device/K003043
Methodology: https://510kreport.com/methodology