# K183054: SYNMESH System

- Pathway: 510(k) (Traditional)
- Applicant: Depuy Synthes Spine
- Decided: May 23, 2019 after 202 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: 1 generation back to K003275 (2001). 1 ancestor in all.
No later device cites it as a predicate yet.
0 of 2 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 4.

## Indications for use
The SYNMESH™ Spacer is a vertebral body replacement device intended for use in the thoracolumbar spine (T1-L5) to replace a collapsed, damaged, or unstable vertebral body due to tumor or trauma (i.e., fracture). The SYNMESH Spacer is intended to be used with Synthes supplemental internal fixation systems. The interior of the SYNMESH Spacer can be packed with bone graft. The SYNMESH™ System is designed to provide anterior spinal column support even in the absence of fusion for a prolonged period.

Source page: https://510kreport.com/device/K183054
Methodology: https://510kreport.com/methodology