Precision Spine said today it won FDA 510(k) clearance for its AccuFit lateral plating system designed to treat spinal instability.
The Parsippany, N.J.-based company’s AccuFit lateral plate system consists of non-sterile, single use rigid plates designed to attach to the lateral portions of the vertebral body of the thoracolumbar spine with bone screws.
“As a system that utilizes a lateral approach, AccuFit helps bring about a full range of operative and postoperative benefits designed to optimize patient outcomes,” system developer Dr. Andrew Cappuccino said in prepared remarks.
The device is now indicated for use through a lateral or anterolateral surgical approach either above the bifurcation of the great vessels to treat thoracic and thoracolumbar spine instability, or through the anterior surgical approach below the bifurcation of the great vessels to treat lumbar and lumbarsacral spine instability.
“The AccuFit Lateral Plate System is an important addition to our growing portfolio of devices for use in the lateral approach to spine surgery and is designed to be used in conjunction with our MD-Vue Lateral Access System. The MD-Vue System is the only lateral retractor that offers a unique and patented nested 3-blade design, which prevents blade creep during insertion. Together, these lateral devices provide surgeons with a safe, reproducible approach designed to decrease OR time, shorten costly hospital stays and achieve efficient, positive patient outcomes,” COO Chris DeNicola said in a press release.
In September, Precision Spine said it won FDA 510(k) clearance for its its reform modular and hydroxyapatite coated pedicle screw systems.
The modular screw system is designed with a cobalt chrome tulip and proximal tapered triple lead thread designed to enhance pull-out strength and increase visibility, the company said.