SI-Bone's iFuse Bedrock Granite implant system for sacroiliac fusion and sacropelvic fixation received FDA clearance.
The device had earlier FDA designation as a breakthrough device and received a new technology add-on payment from CMS, according to a May 31 news release. It is designed for sacropelvic anatomy.
The iFuse Bedrock Granite is also expected to reduce the need for reoperations in spinal deformity cases, the release said.