The FDA granted DiFusion 510(k) clearance for its Xiphos-Zfuze spinal interbody device.
Four insights:
1. Xiphos-ZF is the first implant developed from a new biomaterial called Zfuze.
2. Zfuze is a load-bearing biomaterial that evokes a pro-reparative macrophage phenotype rather than a pro-inflammatory phenotype.
3. Paul Kraemer, MD, of Indiana Spine Group in Carmel is set to perform the first spinal surgery with Xiphos-ZF.
4. DiFusion will launch Xiphos-ZF in the fourth quarter.