Life Spine announced today that it has received FDA clearance to market a sacroiliac (SI) revision offering and additional claims for the SImpact sacroiliac joint fixation system.
The new clearance adds a 14.5mm diameter screw to Life Spine’s SI fixation portfolio to fill a gap in the market for revision surgeries. The larger screw joins the current offering of self-drilling 12mm and 8mm diameter threaded implants.
“As sacroiliac fusions become more mainstream, revision surgeries are increasing due to failures of early devices and poor surgical technique,” said Dr. Ali Mesiwala of the Southern California Center for Neuroscience and Spine in a news release. “Currently, revision strategies for a non-union or malpositioned implant involve removal of the prior implant, placement of new instrumentation and addition of bone graft. A particularly challenging problem with these cases is how best to fill the void of bone that is left when the old implant is removed. The large diameter of the SImpact revision implant allows one to fill the bone void while supplying immediate fixation to the site.”
The FDA also granted additional claims, indications, and length offerings to the SImpact system. The implant is self-harvesting and can be used prophylactically in long construct cases. All implants in the system are now offered in overall lengths of 30mm – 110mm in 5mm increments. Lastly, the 8mm diameter lag screws now include the aggressive self-drilling screw tip geometry that allows for minimized surgical steps, the company said.