Life Spine announced today that it won FDA 510(k) clearance for its titanium stand-alone anterior lumbar interbody fusion (ALIF) spacer system.
The Huntley, Ill.–based company’s titanium stand-alone ALIF system is designed to approach the spine from the front of the body and remove disc or bone material from in between two adjacent lumbar vertebrae. Life Spine’s system comes in footprints of 34 mm x 24 mm, 38 mm x 28 mm and 42 mm x 30 mm, with three lordotic options of 6°, 12° and 18° and heights ranging from 11–17 mm.
The system is also capable of using barbs, which have teeth and a threaded head designed for ease of removal if the supplemental fixation is utilized. Life Spine is adding the system to its family of stand-alone spacers.
Life Spine has collected seven 510(k) clearances in 2019, including the latest for the ALIF system, and 88 in total since the company was started in 2004, according to a news release. Most recently, it was awarded clearance for its Longbow titanium lateral expendable spacer system.
“This system clearance is the capstone on a year of incredible product launches for us,” Life Spine president & CEO Michael Butler said in the release. “The system boasts our OSSEO-LOC surface technology, a comprehensive offering of footprints, an integrated cam locking mechanism and the option to utilize robust barbs in lieu of screws if supplemental fixation is employed.”
Original Article: (https://www.massdevice.com/life-spine-wins-fda-nod-for-titanium-spine-fusion-spacer-system/)