> ## Content Index
> Fetch the complete content index at: https://www.fdaweb.com/llms.txt
> Use this file to discover other available public pages before exploring further.

# DiFusion Spinal Interbody Device Cleared
- URL: https://www.fdaweb.com/difusion-spinal-interbody-device-cleared/
- Published: 2019-11-04T12:00:00.000Z
- Updated: 2026-09-14T15:51:39.000Z
- Author: David McFarland
- Tags: Devices, #legacy-id-D5145414

FDA has cleared a DiFusion 510(k) for the Xiphos-ZF Spinal interbody device. The device uses a new biomaterial called ZFuze, according to the company. Multiple studies have shown that the ZFuze material elicits pro-reparative M2 macrophage response and significant reductions in Interleukin 1-Beta and Interleukin 6, which are cytokine markers for prolonged inflammation and associated with fibrous tissue formation, it says. Unlike titanium and PEEK (poly-ether-ether-ketone) polymer, ZFuze combines the best of both with a strong integration without the inflammatory fibrous layer and a modulus that is closer to bone, it adds.