The U.S. Food and Drug Administration has approved a major modification to SI-BONE's iFuse Implant System, according to a company news release.
SI-BONE received clearance in Nov. 2008 from the FDA to market its iFuse Implant System. The FDA later worked with SI-BONE to arrive at a more accurate description of the intended use of the iFuse System. The FDA agreed to remove "fracture" from the indications for use and approve the system for use during sacroiliac joint fusion for patients with conditions such as sacroiliac joint disruptions and degenerative sacroiliitis.
The iFuse system is a commercially available device in the U.S. The iFuse procedure uses a minimal incision for the delivery and implantation of small titanium implants. The implants feature a porous plasma spray for decreased implant motion and a strong construct to surgically fix boney structures.
Read the news release about SI-BONE's iFuse Implant System.
Related Articles on SI-BONE:
SI-BONE Begins Post-Market Clinical Experience of iFuse Implant Device
SI-BONE's iFuse Implant System Receives CE Mark
SI-BONE Closes $11M Financing for Commercial and Clinical Expansion
SI-BONE received clearance in Nov. 2008 from the FDA to market its iFuse Implant System. The FDA later worked with SI-BONE to arrive at a more accurate description of the intended use of the iFuse System. The FDA agreed to remove "fracture" from the indications for use and approve the system for use during sacroiliac joint fusion for patients with conditions such as sacroiliac joint disruptions and degenerative sacroiliitis.
The iFuse system is a commercially available device in the U.S. The iFuse procedure uses a minimal incision for the delivery and implantation of small titanium implants. The implants feature a porous plasma spray for decreased implant motion and a strong construct to surgically fix boney structures.
Read the news release about SI-BONE's iFuse Implant System.
Related Articles on SI-BONE:
SI-BONE Begins Post-Market Clinical Experience of iFuse Implant Device
SI-BONE's iFuse Implant System Receives CE Mark
SI-BONE Closes $11M Financing for Commercial and Clinical Expansion