The FDA has just granted clearance for a new sacroiliac (SI) joint fusion system. Brand-named Integrity SI Fusion System and manufactured by OsteoCentric Technologies of Austin, Texas, the system is indicated for sacroiliac joint fusion for the following conditions:
- Sacroiliac joint dysfunction that is a direct result of sacroiliac joint disruption and degenerative sacroiliitis. This includes conditions whose symptoms began during pregnancy or in the peripartum period and have persisted postpartum for more than 6 months.
- To augment immobilization and stabilization of the sacroiliac joint in skeletally mature patients undergoing sacropelvic fixation as part of a lumbar or thoracolumbar fusion.
- Acute, non-acute, and non-traumatic fractures involving the sacroiliac joint.”
The new SI Fusion system consists of “partially and fully threaded, self-tapping cannulated titanium implants designed to be inserted across sacroiliac joint providing stability for joint arthrodesis.”
William Cross, M.D., an orthopedic surgeon at Mayo Clinic specializing in the treatment of SI-related conditions, said of the system, “The Integrity-SI Fusion System coupled with UnifiMI is designed and optimized to incorporate fusion principles rooted in orthopedic history. These principles include: a biomechanically superior surgical approach, aggressive joint preparation, auto and allograft application, joint compression, and leading construct stability.”
The sacroiliac joint fusion system is substantially equivalent to the sacroiliac joint fixation system by CoorsTek Medical LLC under the brand name Integrity-SI™ Fusion System. It is also substantially equivalent to the SI-BONE iFuse Implant System® by Si-Bone, Inc. Both are smooth or threaded metallic bone fixation fasteners.
The Integrity-SI Fusion System featuring UnifiMI clearance expands the system’s indications for use in SI trauma, solidifying OsteoCentric’s growing presence in the $9.2 billion worldwide trauma market.
Along with this FDA 510(k) clearance, OsteoCentric is gaining additional momentum in the market with the recent FDA 510(k) clearance of its pedicle screw system and with its growth capital fund, led by OnPoint Advisors. The fund is going to support mechanical integration in both orthopedics and dental.
