The U.S. Food and Drug Administration (FDA) has granted 510(k) clearance to an expandable lateral lumbar interbody system.
Per the 510(k) statement, the device is indicated for “spinal fusion procedures in skeletally mature patients at one or two contiguous levels in the thoracolumbar spine.”
Its thoracic indication is “T1-T2 to T11-T12, or at the thoracolumbar junction (T12-L1), following discectomy for the treatment of a symptomatic degenerative disc disease (DDD), including thoracic disc herniation (myelopathy and/or radiculopathy with or without axial pain).”
According to the 510(k) statement, its lumbar indication is “L1-L2 to L5-S1, for the treatment of DDD with up to Grade 1 spondylolisthesis or retrolisthesis at the involved level(s). DDD is defined as back pain of the discogenic origin with degeneration of the disc confirmed by history and radiographic studies.”
Atlas Spine, Inc., a Florida-based spinal implant company, submitted the device for 510(k) clearance. The recently cleared device is called the HiJAK Expandable Lateral Lumbar Interbody System (HiJAK LLIF).
Atlas Spine CEO and CTO Matt Baynham commented, “Atlas is on an aggressive development pathway toward broadening its expandable technology platform, and this addition is an important step forward for our growth.”
Baynham continued, “The clinical success we have experienced since introducing the market’s first true expandable cervical interbody gives us great confidence as we continue to introduce our future expandable product lines.”
The system’s capabilities are what make it unique. As noted, the system is expandable. According to the press release, the HiJAK LLIF “provides surgeons the opportunity to adjust the implant intra-operatively, to ‘tailor fit’ each patient’s specific needs.” This is thanks to “options which gain up to 30 degrees of angulation” as well as a design with integrated fixation and one without. The capabilities of the HiJAK LLIF help to achieve “optimal segmental lordosis” and also help to restore the spine to its “natural balance.”
