# K041407: Titanium Mesh Implant

- Pathway: 510(k) (Traditional)
- Applicant: Interpore Cross Intl.
- Decided: Dec 29, 2004 after 216 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.
No later device cites it as a predicate yet.
0 of 6 devices in its family (counting itself) have 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.

## Indications for use
The Titanium Mesh Implant is indicated for use in the thoracolumbar spine (i.e., TI to LS) for total replacement of diseased vertebral body(ies) resected or excised for the treatment of tumors in order to achieve anterior decompression of the spinal cord and neural tissues, and to restore the height of a collapsed vertebral body. The Titanium Mesh Implant is also indicated for total vertebral body replacement for the treatment of fractures of the thoracic and lumbar spine. The Titanium Mesh Implant 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 Titanium Mesh Implant is intended to be used with supplemental internal fixation. The supplemental fixation system that must be used with this implant is tile Synergy Spinal System. In addition, the Titanium Mesh Implant is intended for use with bone graft.

Source page: https://510kreport.com/device/K041407
Methodology: https://510kreport.com/methodology