Precision Spine receives FDA 510(k) clearance for AccuFit lateral plating system
US-based Precision Spine has received 510(k) clearance from the US Food and Drug Administration for its lateral plating system AccuFit.
AccuFit Plate significantly adds to Precision Spine’s lateral product portfolio and joins the recently introduced MD Vue lateral access retractor.
The AccuFit plate has been designed to offer optimal stabilisation with a low profile, titanium plating system that has four points of fixation for increased biomechanical rigidity and load sharing.
AccuFit comes in five sizes that are matched to the heights of Precision Spine’s ShruFit LLIF interbody cages. It also has insertion instrumentation that helps in proper anatomical plate alignment with minimal retraction.
The system has 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 different sizes and lengths.
The system is indicated to be used through a lateral or anterolateral surgical approach, above the bifurcation of the vessels in the treatment of thoracic and thoracolumbar (T1-L5) spine instability.
It can also be used through the anterior surgical approach, below the bifurcation of the great vessels in the treatment of lumbar and lumbarsacral (L1-S1) spine instability.
Precision Spine chief operating officer Chris DeNicola said: “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.”
Image: FDA campus at Silver Spring, Maryland, US. Photo: Courtesy of Bluerasberry/Wikipedia.