FDA Clears Binder Biomedical’s Anterior Lumbar Fixation System

Binder Biomedical Inc. has announced that its new LOGIC intervertebral body fusion device has been cleared by the FDA. The device, a complete anterior lumbar fixation system, features a simple, one-step locking mechanism, bringing stand-alone intervertebral body fusion to treatment of degenerative disc disease.

Background

The LOGIC system is designed for use in a direct anterior surgical approach for accessing the intervertebral disc space of the patient’s lumbar spine. It is indicated for stand-alone intervertebral body fusion in patients with degenerative disc disease, confirmed by radiographic studies, at one or two contiguous levels of the lumbosacral spine (L2-S1).

Each LOGIC implant is designed with a large central window for optimum autograft bone placement. Size offerings range from 10 to 20 mm in height, and all devices have an anatomically-shaped lordotic angle that matches the convex curvature of the vertebral endplates.

The device is implanted into the intervertebral space and then three screws are placed through the device, into the vertebrae to provide stabilization and facilitate fusion.

In common with a number of other spinal implants, the system is manufactured using the PEEK-OPTIMA® polymer from Invibio Biomaterial Solutions.

In a press release, Binder Biomedical says sales will commence with an alpha launch  in the first quarter of 2014 with full availability later in the year.

Company comments

Binder Biomedical President Lawrence Binder said: “We are excited to bring such a streamlined device to market. Our design team has done a great job putting together such a comprehensive system, ensuring that it can be tailored to any surgeon’s preferred surgical technique.”

Team member Peter Whang (MD, FACS) is an associate professor in the Department of Orthopedics, Yale University School of Medicine. “Rather than being content with the industry standard,” he said, “we have created a truly innovative system that reflects our lengthy collective experience as surgeons and engineers. Together, we have created a world-class system that meets all of our needs while maintaining ease of use.”

Source: Binder Biomedical, Inc. , PR Newswire