Life Spine Grabs Additional 510(k) Clearance for Joint-Fixation System
Life Spine has received an additional 510(k) clearance for its SImpact Sacroiliac Joint Fixation System, allowing it to be used with longer screws for spinopelvic fixation.
The agency’s clearance adds a 14.5mm-diameter screw size to the system, which fills a gap in the market for revision surgeries, the company said. Previously, the system offered 12mm and 8mm diameter screws.
In addition, all implants in the system are now offered in overall lengths of 30mm to 110mm in 5mm increments, and its 8mm-diameter lag screws now include self-drilling tips to allow for fewer surgical steps.