510(k) Clearance for Expandable Anterior Lumbar Interbody System

An expandable anterior lumbar interbody system has received U.S. Food and Drug Administration (FDA) 510(k) clearance.

The device, according to the FDA 510(k) summary document, is indicated for “intervertebral body fusion procedures in skeletally mature patients with degenerative disc disease (DDD) of the lumbar spine at one or two contiguous levels from L1-L2 to L5-S1.”

According to the FDA document, “DDD is defined as discogenic pain with degeneration of the disc confirmed by history and radiographic studies.” Additionally, these DDD patients may also have “up to Grade I spondylolisthesis or retrolisthesis at the involved level(s).” The system implants “are to be used with autogenous bone graft and supplemental fixation.” Patients should have “at least six (6) months of non-operative treatment prior to treatment with an intervertebral cage.” The spacer and plate assembly are an “integrated interbody fusion device intended for stand-alone use when used with all titanium alloy screws.”

The FDA also wrote, “When used with anchors only the zero plate may be used and the assembly is intended for use with additional supplemental fixation that has been cleared by the FDA for use in the lumbar spine.”

Additionally, hyperlordotic interbody devices (>20° lordosis), oblique interbody devices, and the device must be used with “supplemental fixation (e.g. posterior fixation) that has been cleared by the FDA for use in the lumbar spine.” The spacer “may only be used with titanium alloy screws.”

A device must be substantially equivalent to a predicate device to qualify for 510(k) clearance. The primary predicate device is an anterior lumbar interbody fusion system by the same company who submitted the 510(k) document.

Astura Medical, a spine technology company based in Irving, Texas, submitted the device for 510(k) clearance. According to Astura, the El Capitan X Expandable Anterior Lumbar Interbody System “provides a complete range of expandable anatomic spacers and fixation options with infinitely adjustable expansions in height and lordosis up to 30° for a unique, patient-specific solution.”

Astura Medical Co-founder and Vice President Thomas Purcell said, “The approval of El Capitan X represents a new benchmark for what’s possible in the anterior lumbar fusion marketplace.”

Thomas Purcell continued, “By becoming the first and only system to combine integrated plate and spacer options, along with customizable expandable interbody capabilities, the system delivers on our goal of providing more intraoperative flexibility and versatility than any other ALIF system on the market. El Capitan X is redefining what it means to deliver a truly patient-specific solution.”