Life Spine Gains FDA 510(k) for SI Joint Revision, New Claims for SImpact Sacroiliac Joint Fixation System

By Julie A. Vetalice

Life Spine Gains FDA 510(k) for SI Joint Revision, New Claims for SImpact Sacroiliac Joint Fixation System

Life Spine received FDA 510(k) clearance to add a 14.5mm diameter screw to its sacroiliac (SI) joint revision platform, and additional claims for the SImpact SI joint fixation system.

The new screw size addresses gap in the market for revision surgeries, joining the company's self-drilling 12mm and 8mm diameter threaded implants.

The SImpact system received additional claims, indications and length offerings. 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 SImpact system is already a robust offering for SI fixation. The additions of the revision screw, updated lag screw, and the new indications are great adjuncts to the portfolio,” said Dr. Keith Maxwell of Southeastern Sports Medicine and Orthopedics. “The system provides an innovative answer to long construct spinopelvic fixation and having implant lengths up to 110mm makes it an ideal system to be used in trauma cases. I have performed numerous SI fixation procedures with many different implants and SImpact is the most appealing system on the market.”

Product Labels: Spinal Fusion

Tags: 510(k) Clearance, Regulatory