# K032371: Titanium Mesh System

- Pathway: 510(k) (Traditional)
- Applicant: Encore Medical L.P.
- Decided: Feb 12, 2004 after 195 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). 5 ancestors in all.
26 later devices descend from it; 1 cites it directly.
0 of 32 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K003275: Synthes Synmesh Spacer System, Synthes (Usa) (2001) Summary page 1.
- K003709: Surgical Dynamics Mesh Cage System, United States Surgical, A Division of Tyco Healthc (2001) Summary page 1.
- K003043: Surgical Titanium Mesh System, Depuyacromed (2001) Summary page 1.

## Most influential descendants
- K070381: Theken VU Mesh VBR System (2007), 25 descendants of its own
- K111294: Santorini Spinal System (2012), 18 descendants of its own
- K142016: CAPRI (2014), 12 descendants of its own
- K170055: CAPRI Corpectomy Cage System (2017), 11 descendants of its own
- K171704: CAPRI Corpectomy Cage System (2017), 10 descendants of its own

## Indications for use
The Titanium Mesh System is indicated for use in the thoracolumbar spine (Ti-L5) to replace a collapsed, damaged, or unstable vertebral body due to tumor or trauma (i.e. fracture), to achieve anterior decompression of the spinal cord and other neutral tissues, and to restore the height of a collapsed vertebral body. The Titanium Mesh 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

Source page: https://510kreport.com/device/K032371
Methodology: https://510kreport.com/methodology