SI-BONE gets expanded approval from US FDA for iFuse Bedrock Granite

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Medical devices maker SI-BONE has received additional approval from the US Food and Drug Administration (FDA) for its iFuse Bedrock Granite implant system.

The newly approved indications feature the use of the implant system with a wide class of pedicle screw system rods.

In May this year, the company launched iFuse Bedrock Granite to improve surgical outcomes with spinal alignment, biologics, and next-generation pelvic fixation implants.

Designed to immobilise and fuse the sacroiliac (SI) joint, the implant will act as foundational support at the base of a spine fusion construct.

Initially, the approval included an indication for use with a single manufacturer’s pedicle screw system. 

The expanded indications include use with a broad range of rods that are usually leveraged in multilevel spine fusion surgeries.

These indications will enable surgeons to deploy their techniques and implant systems along with iFuse Bedrock Granite as the foundation for their construct.

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.”

In 2009, SI-BONE launched the iFuse Implant System for minimally invasive surgery of the SI joint.

The company is engaged in the development of technologies for the surgical treatment of musculoskeletal disorders of the sacropelvic anatomy.

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• Source: https://www.medicaldevice-network.com/news/si-bone-fda-ifuse-bedrock-granite/