510(k) Clearance for MiRus’ IO Expandable Lumbar Interbody

Marietta, Georgia-based MiRus, LLC has received U.S. Food and Drug Administration (FDA) 510(k) clearance for its IO™ Expandable Lumbar Interbody.

MiRus develops medical devices and procedural solutions for spine, orthopedic, and cardiovascular issues. Its technology includes its rhenium-based superalloy medical implants.

According to the press release, the IO Expandable Lumbar Interbody can be utilized in both posterior lumbar interbody fusion (PLIF) and transforaminal lumbar interbody fusion (TLIF) procedures. Additionally, “[i]t features the lowest insertion profile (4mm) and greatest expansion (18mm) and lordosis (24^◦) in a single implant of any expandable interbody on the market.”

MiRus Founder and CEO Jay S. Yadav, M.D. commented, “The FDA approval of the IO™ Expandable Lumbar Interbody is a breakthrough for surgeons and patients wishing truly less invasive spine surgery. It also marks a significant milestone in our development of complex rhenium-based medical implants.”

According to the FDA documents, the device description is as follows: “The IO™ Expandable Lumbar Interbody Fusion System is an expandable lumbar interbody fusion device used to provide structural stability in skeletally mature individuals following discectomy.”

“The IO™ Expandable Lumbar Interbody Fusion System consists of implants manufactured from titanium alloy (ASTM F136). Expansion mechanism components and the drive screw are manufactured from molybdenum rhenium (MoRe) alloy (ASTM F3273).”

“The system is offered in various sizes to accommodate different patient anatomy requirements. Implants will be provided sterile and are intended for single use only.”

Per the FDA documents, the indications for use are as follows: “The IO™ Expandable Lumbar Interbody Fusion System 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 Ll-L2 to L5-Sl. DDD is defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies. These DDD patients may also have up to Grade I spondylolisthesis or retrolisthesis at the involved level(s). Devices are to be used with autograft and/or allogenic bone graft comprised of cancellous and/or corticocancellous bone graft and supplemental fixation. Patients should have at least six (6) months of non-operative treatment prior to treatment with an intervertebral body fusion device.”