Si-Bone (Nasdaq:SIBN) announced today that it received additional FDA clearance for its iFuse Bedrock Granite implant.
New indications for the implant include use with a range of commercially available pedicle screw systems.
Santa Clara, California-based Si-Bone received FDA 510(k) clearance for iFuse Bedrock Granite for spinal procedures in May. It designed the implant to provide sacroiliac (SI) fusion and sacropelvic fixation for segmental spinal fusion.
Its uses include immobilizing and fusing the sacroiliac joint. It also serves as foundational support at the base of a spine fusion construct.
The FDA’s initial clearance covered use with a single manufacturer’s pedicle screw system. Expanded indications include use with a range of rods used in multilevel spine fusion surgeries. According to a news release, this allows surgeons to use preferred techniques an implant systems with the iFuse implants as their foundation.
Dr. Robert Eastlack of Scripps Hospital said patients can require a variety if implant solutions for the best outcomes. He called iFuse Bedrock Granite “the most advanced technology available” at the base of his spinal constructs.
“Since launch, Granite has become the preferred implant for surgeons as they incorporate SI joint fusion into their pelvic fixation constructs,” said Laura Francis, CEO of Si-Bone. “We believe that this expanded clearance will help increase the number of surgeons who treat their patients with this breakthrough device.”