Providence Medical Technology, announced FDA 510K clearance for its ALLY™ Posterior Fixation System. The system is intended to provide immobilization and stabilization of spinal segments as an adjunct to fusion for acute and chronic instabilities of the cervical spine (C1 to C7) and is compatible with the company’s flagship DTRAX® Spinal System. [/junkie-alert]
DTRAX Spinal System is a set of sterile packaged, single-use instruments designed to perform posterior cervical fusion and has been used in over 7,000 cases worldwide. Posterior cervical fusion is indicated for patients with symptomatic nerve root involvement and/or mechanical instability. Spinal implants are typically used as an adjunct to posterior cervical fusion cases, and the newly cleared ALLY Posterior Fixation System is the latest addition to the family of spinal fusion implants offered by Providence. Providence also offers CAVUX® Cervical Cages, ALLY Bone Screws, and ALLY Facet Screws as options for spinal instrumentation during cervical fusion procedures.
Jeff Smith, CEO of Providence notes, “We are encouraged by the continued adoption of our posterior cervical fusion technology. Surgeons are increasingly considering posterior cervical fusion with intervertebral cages and supplemental screw fixation when treating patients with cervical spine disorders.” Smith concluded, “The regulatory clearance of ALLY Posterior Fixation System is an important milestone and reflects our commitment to continued innovation and expansion of our differentiated product offering.”
Providence recently announced multiple independent clinical studies supporting the safety, efficacy, and cost-efficiency of its posterior cervical fusion technology. The company will be exhibiting at the annual meeting of the North American Spine Society (NASS) in Orlando, Florida, on October 25-28, booth #1140.