US-based Binder Biomedical has obtained the Food and Drug Administration (FDA) clearance for its Logic, a new anterior lumbar fixation system designed for use in a direct anterior surgical approach for accessing the intervertebral disc space of the patient's lumbar spine.
Logic incorporates a simple one-step locking mechanism, which simplifies stand-alone intervertebral body fusion surgery.
The large central window of the each fixation system allows for optimum placement of bone autograft.
The fixation system also has three locking screws to provide stabilization and facilitate spinal fusion.
All the devices feature an anatomically-shaped lordotic angle to match the convex curvature of the vertebral endplates.
The fixation systems are available in sizes ranging from 10mm to 20mm in height.
Binder Biomedical president Lawrence Binder said the company is 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," Binder added.
In 2010, the company entered into a supply assurance agreement with Invibio Biomaterial Solutions, a developer of orthopaedic biomaterials, to provide its Peek-Optima polymer for use in spinal fusion devices.
Binder Biomedical has used Peek-Optima polymer from Invibio in manufacturing the Logic devices.
The limited release is planned for the first quarter of 2014, while the nationwide launch is expected by the fourth quarter of 2014.