FDA Nod for Altus Spine’s Cervical Plate System March 14, 2017
Spinal correction surgery specialist Altus Spine, has gained FDA 510(k) clearance for its Fuji Cervical Plate System. The Fuji Cervical Plate System is a semi-constrained fixation system intended to provide stabilization of the anterior cervical spine.
Altus Spine says it is among the fastest growing spinal implant companies in the world, claiming its devices are already used by over 100 hospitals across the United States. .
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, trauma (including fractures), tumors, deformity (defined as kyphosis, lordosis, or scoliosis), pseudosarthrosis and/or failed previous fusions. The Altus Spine Cervical Plate System can be implanted in the sub-axial cervical spine from the C3 through C7 levels.
The system incorporates 28° screw angulation with advanced locking technology. This capability provides surgeons with increased flexibility in screw placement and high reliability in screw locking. To give surgeons greater confidence, the screw locking mechanism is specifically designed to allow visual, tactile and radiographic confirmation of locking. The system is offered with 1- to 4-level fixation plates and dual thread form screws to address most surgeons’ needs.
After performing the first Fuji Cervical Plate implantation, Jim Lowe, MD, Chief of Spine at AtlantiCare Regional Medical Center, stated “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.”
“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.”
Source: Altus Spine, Inc.