Huntley, Illinois-based medical device company Life Spine announced that it has secured the US Food & Drug Administration’s (FDA) 510(K) approval to sell its Titanium Stand-Alone ALIF Spacer System.
The Titanium Stand-Alone ALIF System is a device which comes in the sizes of 34mm x 24mm, 38mm x 28mm and 42mm x 30mm. The device has three lordotic options of 6°, 12° and 18° and heights ranging from 11-17mm.
The screws in the system allow for a stand-alone use of the system, offering up to 45° angulation. In addition, the system can also be used with barbs, featuring teeth and threaded head designed for easy removal, if supplemental fixation is used.
The Titanium Stand-Alone ALIF System joins the company’s family of Dyna-Link Stand-Alone Spacers and is complemented by simplified instrumentation and its ALIF Disc Prep Instruments.
The system is the seventh product of Life Spine to secure FDA approval this year
Life Spine stated that the 510(k) clearance from FDA is its seventh this year and is the company’s 88th since their inception in 2004.
Some of the products and procedures cleared this year include the CENTERLINE Modular Thoracolumbar Fixation System, the LONGBOW Titanium Expandable Spacer System and extended approvals for the PROLIFT Expandable Spacer System in new narrow and lateral offerings.
Life Spine president and CEO Michael Butler said: “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 utilize robust barbs in lieu of screws if supplemental fixation is employed.”
Last month, the company also secured FDA clearance to sell its LONGBOW Titanium Lateral Expandable Spacer System in the US.
Featuring the company’s OSSEO-LOC Surface Technology, the LONGBOW system can be post-packed after expansion in-situ with up to 11cc of graft to fill the implant.
The system is supported by Life Spine’s full portfolio of Lateral solutions including the CENTRIC Plier Style Retractor System, Lateral Disc Prep Instruments and the SENTRY Lateral Plating Systems.
