Life Spine has received FDA clearance to market its titanium stand-alone anterior lumbar interbody fusion (ALIF) spacer system. The system comes in footprints of 34mm x 24mm, 38mm x 28mm and 42mm x 30mm. Additionally, there are three lordotic options of 6 degrees, 12 degrees and 18 degrees and heights ranging from 11mm to 17mm. The screws allow for stand-alone use of the system and offer angulation up to 45 degrees.
The system can also be used with barbs, which feature teeth and a threaded head designed for ease of removal, if supplemental fixation is used. A press release reports that system will join Life Spine’s family of Dyna-Link stand-alone spacers and is complemented by simplified instrumentation and Life Spine’s ALIF disc prep instruments. This 510(k) is the seventh in 2019 for Life Spine and their 88th since inception in 2004. Clearances in 2019 have included the Centerline modular thoracolumbar fixation system, the Longbow titanium expandable spacer system and extended approvals for the Prolife expandable spacer system in new narrow and lateral offerings.
Michael Butler, president and CEO of Life Spine, comments: “This system clearance is the capstone on a year of incredible product launches for us. The system boasts our Osseo-Loc surface technology, a comprehensive offering of footprints, an integrated cam locking mechanism and the option to use robust barbs in lieu of screws if supplemental fixation is employed.”