DiFusion Gains FDA Clearance for Xiphos ZFUZE Biomaterial

By Julie A. Vetalice

DiFusion received FDA 510(k) clearance for the Xiphos-ZF spinal interbody device made from ZFUZE biomaterial. ZFUZE is designed to present an alternative to the limitations of PEEK and titanium for load-bearing implants.

Studies have shown that ZFUZE material elicits a pro-reparative M2 macrophage response and significant reductions in Interleukin (IL) 1-Beta and IL6, which are cytokine markers for prolonged inflammation and associated with fibrous tissue formation.

Product launch will occur in 4Q19, and will be followed by an ACL repair screw in early 2020.

Derrick Johns, Founder and CEO, said, “After 10 years of research, hundreds of in vitro cell assays and three major animal studies, we achieved a goal no large company would dare to even undertake – bringing to market the first entirely new biomaterial specifically engineered for orthopedic surgical procedures.”

Product Labels: Traditional Soft Tissue Repair, Spinal Fusion

Tags: 510(k) Clearance, Regulatory