Binder Biomedical has received US Food and Drug Administration (FDA) approval for its Logic, an anterior lumbar fixation system with a simple, one-step locking mechanism.
The new stand-alone intervertebral body fusion device is designed for use in a direct anterior surgical approach for accessing the intervertebral disc space of the patient’s lumbar spine.
The limited release is planned for the first quarter of 2014, with the nationwide launch expected by the fourth quarter of 2014.
Binder Biomedical president Lawrence Binder said: "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."
Each implant is equipped with a large central window for optimum autograft bone placement and includes three locking screws that provide anterior fixation and stability.
All the devices feature an anatomically-shaped lordotic angle to match the convex curvature of the vertebral endplates and are available in sizes ranging from 10mm to 20mm in height.
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 radiographic studies also affirmed that the Logic is indicated for stand-alone intervertebral body fusion in patients with degenerative disc disease, at one or two contiguous levels of the lumbosacral spine (L2-S1).
All Logic devices are manufactured in the FDA-registered facilities in the US.
According to GlobalData estimates, the spinal fusion market in the US was valued at $3.9bn in 2012 and is expected to grow at a CAGR of 1.9% to reach $4.5bn by 2019.