Si-Bone’s iFuse Implant System Gets Expanded Clearance

The FDA has granted an additional clearance to Si-Bone for its iFuse Bedrock Granite implant system for spinal fusions, expanding its compatibility with pedicle screw system rods.

The system first received FDA clearance in May, but was only indicated for use with one manufacturer’s pedicle screw system. The expanded indications include use with “a wide range of rods that are commonly used in multilevel spine fusion surgeries,” the company said.

The system previously received Breakthrough Device status from the FDA.