Altus Spine: FDA Clearance for Fuji Cervical Plate System
Elizabeth Hofheinz, M.P.H., M.Ed. • Thu, March 9th, 2017
Altus Spine, based in West Chester, Pennsylvania, has announced the FDA clearance and market introduction of the Fuji Cervical Plate System. The Fuji System is a semi-constrained fixation system intended to provide temporary stabilization of the anterior cervical spine.
“Our surgeon users and hospital customers wanted the next generation cervical plate system, so they worked closely with our engineers and designers to develop it,” says Michael Fitzgerald, president and CEO. “The system will help to improve patient care by giving surgeons a stabilization system that incorporates class-leading features yet is simple to use.”
After performing the first Fuji Cervical Plate implantation, Jim Lowe, M.D., chief of spine at AtlantiCare Regional Medical Center, stated in the February 14, 2017 news release, “The Fuji plate system is easy to use allowing me to place screws precisely. The screw blockers also have nice visual and tactile feedback when locked. The combination of ease of use and positive locking will make Fuji my plate of choice.”
As indicated in the news release, “The Fuji Cervical Plate System is intended for anterior interbody fixation of the cervical spine. The system is indicated for use in temporary stabilization of the anterior spine during the development of cervical spine fusions in patients with degenerative disc disease (as defined by neck pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies); trauma (including fractures), tumors, deformity (defined as kyphosis, lordosis, or scoliosis), pseudosarthrosis and/or failed previous fusions. The Fuji Cervical Plate System can be implanted in the sub-axial cervical spine from the C3 through C7 levels.”
Patrick White, lead system developer, stated “Fuji plate development was driven by market feedback. Market feedback translates into these attributes: up to 28 degree screw angulation; visual, tactile, and radiographic confirmation of locking; one T15 driver for screw placement and locking; and dual thread form screws available, among other things.”
Brian Bankoski is vice president of Product Development at Altus. He told OTW, “Our development philosophy involves close collaboration with surgeons. Altus worked with surgeons who are key opinion leaders to create a cervical plate system that is simple and robust yet provides many best-in-class features. The Fuji system fully incorporates the most important surgeon needs into an implant that inspires confidence.”