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FDA clears DiFusion Xiphos interbody implants

DiFusion Technologies, a medical device developer of CleanFuze anti-microbial technology for orthopedic implants, has received US Food and Drug Administration 510(k) clearance for its new Xiphos line of posterior interbody devices.

The Xiphos devices are indicated for intervertebral body fusion of the lumbar spine, from L2 to SI, in skeletally mature patients who have had six months of non-operative treatment.

The device is intended for use at either one level or two contiguous levels for the treatment of degenerative disc disease (DDD) with up to Grade I spondylolisthesis.

The Xiphos System of implants is also indicated for use to replace a vertebral body that has been resected or excised due to tumor or trauma/fracture.

The system is intended for the thoracolumbar spine (from T1 to L5) and for use with supplemental internal fixation.

DiFusion Technologies Development VP Jami Hafiz said that the Xiphos posterior interbody platform includes an array of implant shapes and sizes for varying patient anatomy and surgical preference allowing for posterior, posterior oblique and transforaminal approaches.

“We really focused on developing a best in class series of implants that could serve as a platform for future development,” Hafiz said.