Fuji FDA 510(k) Clearance
West Chester, PA- February 14, 2017 – Altus Spine, a leader in the innovation and development of medical devices used in spinal correction surgery, announces the FDA clearance and market introduction of the Fuji Cervical Plate System. The Fuji Cervical Plate System is a semi-constrained fixation system intended to provide stabilization of the anterior cervical spine.
The Fuji Cervical Plate System is a market leading anterior cervical spine stabilization system that 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.
“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 today, 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.”
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 Altus Spine Cervical Plate System can be implanted in the sub-axial cervical spine from the C3 through C7 levels.
Based in West Chester, PA, Altus Spine is dedicated to creating the next generation of medical devices. Altus strives to improve patient care by designing and developing products to meet the highest standards in an ever changing and evolving field. Implemented and used by over 100 hospitals across the United States, Altus is among the fastest growing spinal implant companies in the world.
Forward Looking Statements
All statements made in the above press release, with the exception of historical fact, may be forward-looking statements that include risk, uncertainty, and assumptions. These factors could cause Altus Spine’s results to differ from those predicted if they do not occur as expected. These uncertain factors include, but are not limited to; acceptance and clearance of the company’s surgical products and procedures, development of new products and procedures, innovations and alterations to existing products and procedures, clinical and statistical verification of the success using Altus Spine’s products, company’s ability to maintain and monitor inventory as it releases new products, its ability to hire and retain personnel, and any other risks stated in prior or subsequent news releases. All risks and potential complications can be found in our most recent 510k report from the Food and Drug Administration (FDA). Given the constantly changing market, readers are encouraged to not place undue reliance on forward looking statements. Altus Spine assumes no obligation to update forward-looking statements as these changes occur, or as events and circumstances are altered, after the date they are posted.