FDA Clears ‘First’ Oblique Anterior Lumbar Interbody Implant

On April 4, 2022, Texas-based Astura Medical announced the FDA 510(k) Clearance for its El Capitan Oblique Anterior Lumbar Interbody Fusion (ALIF) System. It is the company’s fourth clearance.

According to FDA documents, the system is indicated for intervertebral body fusion procedures in skeletally mature patients with degenerative disc disease of the lumbar spine at one or two contiguous levels from L1-L2 to L5-S1. These patients may also have up to Grade I spondylolisthesis or retrolisthesis at the involved levels.

The system, says the company, builds on the company’s other plate and spacer technologies addressing anterior cervical, lateral lumbar, and traditional anterior lumbar approaches. The company stated the lumbar system was specifically designed “to deliver the widest array of construct options with the most efficient and streamlined supporting instrumentation in the oblique anterior lumbar surgery marketplace today.”

“We set out to provide a system that would establish a higher benchmark for intraoperative versatility, flexibility, and efficiency in oblique anterior lumbar surgery,” said Tom Purcell, co-founder and vice president.

El Capitan

The company claims the El Capitan is the “first system to provide multiple, customizable plating and fixation options in oblique anterior lumbar procedures.” The plating options allow for either a Zero-Profile, Half Plate, or Full Plate that can be implanted in combination with the interbody from either a left or right sided approach. “By providing either Anchoring Nails or Screws, which can be delivered via multiple techniques including an All-in-One option, El Capitan Oblique can accommodate the wide variance of anatomical challenges presented in oblique anterior lumbar surgery.”

According to the FDA documents, the implants were developed for the substitution of the classical autogenous bone graft blocks.

The cages “assist to avoid complications” related to the bone graft donation site (chronic pain, hematoma, infection, bone removal from the donor site making it impossible to remove bone again, quality of the iliac bone, accessing a healthy donor site that may become an unhealthy site, hernias by the incision).

“The Spacers are a 2-piece modular design which allows for interchangeable plate and spacer components.

The plate and spacer components contain interlocking features in addition to a spring-loaded latch mechanism which allows for intraoperative assembly prior to implantation.”

The implants have a hollow center to allow placement of autogenous bone graft. The superior and inferior surfaces are open “to promote contact of the bone graft with the vertebral end plates, allowing bone growth (arthrodesis).”

Hyperlordotic interbody devices (>20° lordosis) and the Oblique interbody devices must, according to the FDA, be used with supplemental fixation (e.g., posterior fixation) that has been cleared by the FDA for use in the lumbar spine

Astura Medical

Astura Medical was formed in 2014. In 2019 the company relocated its corporate headquarters from Carlsbad, California to a new 40,000 square foot facility in Irving, Texas.