The US Food and Drug Administration (FDA) has cleared Providence Medical Technology to market Ally in the USA.
Ally is a posterior fixation system, intended to provide immobilisation and stabilisation of spinal segments as an adjunct to fusion.
The system is designed to aid treatment for acute and chronic instabilities of the cervical spine, and is compatible with the company’s flagship DTRAX spinal systems.
DTRAX product line
DTRAX is a set of sterile packaged, single-use instruments designed to perform posterior cervical fusion. The line received CE mark in 2015, and has been used in over 7,000 cases to date. The Australian Therapeutic Goods Association approved DTRAX earlier this year.
“Surgeons are increasingly considering posterior cervical fusion with intervertebral cages and supplemental screw fixation when treating patients with cervical spine disorders,” says Providence chief executive officer, Jeff Smith. “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.