FDA Clears Precision Spine’s AccuFit Lateral Plating System

Precision Spine Inc. announced that it recently received 510(k) clearance of its AccuFit Lateral Plating System.
 
The AccuFit Plate represents a significant addition to the Precision Spine lateral product portfolio and joins the recently introduced MD Vue Lateral Access Retractor. The AccuFit Plate is designed to provide optimal stabilization with a low profile, titanium plating system that features four points of fixation for enhanced biomechanical rigidity and load sharing. AccuFit features five sizes that are matched to the heights of Precision’s ShurFit LLIF Interbody cages. The system also includes insertion instrumentation to ensure proper anatomical plate alignment with minimal retraction.
 
“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,” said Andrew Cappuccino, MD, who worked closely with Precision Spine design engineers in the development of the system.
 
“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,” said Chris DeNicola, Chief Operating Officer of Precision Spine. “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.”
 
The AccuFit Lateral Plate System consists of non-sterile, single use rigid plates that attach to the lateral portion of the vertebral body of the thoracolumbar spine (T1-L5) by means of bone screws of varying sizes and lengths. The system is indicated for use via a lateral or anterolateral surgical approach, above the bifurcation of the great vessels in the treatment of thoracic and thoracolumbar (T1-L5) spine instability, or via the anterior surgical approach, below the bifurcation of the great vessels in the treatment of lumbar and lumbarsacral (L1-S1) spine instability. The system is intended as a temporary fixation device until fusion is achieved.