510K clearance for Xiphos-ZF Spinal interbody device

January 6, 2020 0 By FM

Difusion Technologies has received 510K clearance for the Xiphos-ZF Spinal interbody device.

Xiphos-ZF is the first spinal implant developed from a new biomaterial called ZFUZE. 

Multiple studies have shown the ZFUZE material elicits pro-reparative M2 macrophage response and significant reductions in Interleukin 1-Beta and Interleukin 6. IL1-Beta and IL6 are cytokine markers for prolonged inflammation and associated with fibrous tissue formation.

The company plans to launch Xiphos ZFUZE in the spinal market in Q4 2019 and an ACL repair screw in early 2020 in the sports medicine market.

Current orthopaedic manufacturers are limited to titanium or PEEK as the only material choice for load-bearing implants. PEEK forms a fibrous layer and doesn’t integrate, so heals poorly. Titanium is so much stiffer than osteoporotic bone that it subsides quite often.

This biomaterial has strong integration without the inflammatory fibrous layer, and a modulus that is closer to the bone, according to Difusion.