DiFusion’s New Biomaterial-Using Spinal Implant Gains FDA Clearance

The FDA has handed 510(k) clearance to DiFusion for its Xiphos-ZF spinal implant, the first device of its kind to use the new biomaterial Zfuze.

The biomaterial’s surface is negative charged, microporous, and hydrophilic rather than hydrophobic, allowing it to support bony ingrowth while keeping the mechanical properties and imaging capabilities of traditional PEEK (polyetheretherketone) implants.

Zfuze can be injection molded, 3D printed or machined, and surface treatments such as laser etching and nano-surfacing can be performed on the material, DiFusion said.