The expanded indications will enable surgeons to use their chosen methods and implant systems with iFuse Bedrock Granite as the base for their construct
SI-BONE secures additional FDA clearance for iFuse Bedrock Granite for use with commercially available pedicle screw system rods. (Credit: SI-BONE, Inc.)
Medical device company SI-BONE has secured an additional US Food and Drug Administration (FDA) clearance for iFuse Bedrock Granite for use with a range of commercially available pedicle screw system rods.
According to the firm, the implant is often utilised to stabilise the base of a spine fusion construct and to immobilise and fuse the sacroiliac (SI) joint.
The initial indication was based on the use of the system with a single manufacturer’s pedicle screw system. The expanded indication now includes the use of the implant with a range of rods that are frequently used in multilevel spine fusion surgeries.
With iFuse Bedrock Granite as the base for their construct, the latest indications will enable surgeons to use their chosen methods and implant systems, the medical device firm claimed.
SI-BONE CEO Laura Francis said: “Since launch, Granite has become the preferred implant for surgeons as they incorporate SI joint fusion into their pelvic fixation constructs.
“We believe that this expanded clearance will help increase the number of surgeons who treat their patients with this breakthrough device.”
Introduced in May this year, the iFuse Bedrock Granite was designed to improve spinal alignment, biologics, and next-generation pelvic fixation implants to help improve surgical outcomes.
SI-BONE develops technology for the surgical treatment of musculoskeletal disorders of the sacropelvic anatomy.
Scripps Hospital orthopaedic surgeon Robert Eastlack said: “Many patients with spinal deformity require a thorough surgical plan and a variety of implant solutions to help provide the best outcome.
“By using iFuse Bedrock Granite at the base of my spinal constructs, I am providing my patients with the most advanced technology available.”
In June this year, the company obtained FDA 510(k) premarket clearance for its iFuse Bedrock Granite implant system.
The Granite implant system is intended to offer sacroiliac fusion and sacropelvic fixation as a foundational element for segmental spinal fusion.