23 Sep Life Spine Announces FDA 510(k) Clearance for SI Joint Revision Offering and Additional Claims for the SImpact® Sacroiliac Joint Fixation System
HUNTLEY, Ill.–(BUSINESS WIRE)–Life Spine, a medical device company that designs, develops, manufactures and markets products for the surgical treatment of spinal disorders, announced today that it has received clearance from the U.S. Food & Drug Administration (FDA) to market a 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. The new size focuses on filling a missing 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. “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. This unique implant will self-harvest local bone and can be pre-packed and post-packed with allograft to aid in fusion, making SImpact the go-to system for any SI fusion revision.”
Additional claims, indications, and length offerings have also been granted 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 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.”
About Life Spine
Life Spine is dedicated to improving the quality of life for spinal patients by increasing procedural efficiency and efficacy through innovative design, uncompromising quality standards, and the most technologically advanced manufacturing platforms. Life Spine, which is privately held, is based in Huntley, Illinois. For more information, please visit: http://www.lifespine.com and/or www.sijointfixations.com.
Mr. Omar Faruqi
Chief Financial Officer