US-based medical device company Orthofix has secured regulatory approval from the Japanese Ministry of Health, Labor and Welfare (MHLW) for its PHOENIX minimally invasive spinal (MIS) Fixation System.
The PHOENIX MIS Fixation System screw features an implant design which allows a minimally invasive approach to fix the spine by percutaneously placing pedicle screws which impart stabilisation and correction.
The device has a built-in reduction tower which can be removed by means of a tab removal tool after assembling the implant construct.
The design allows a 14mm working diameter which is small enough to help minimise the surgical incision.
It is comprised of a dilator / awl / tap which dilates and helps awling of the cortical bone, and tap with one single instrument.
The rod inserter featured in the system allows a minimally invasive delivery of the rod without the need of any extra incisions.
The system implants are available in short, standard and tall sizes which are 5.5mm diametre hex end titanium rods.
Orthofix Spine Fixation president Ray Fujikawa said: “The Japanese approval and full market launch of the PHOENIX MIS fixation system represents an important step towards broadening the availability of our spine fixation products globally by entering the second largest spine market in the world.
“We are committed to continuing to work towards securing additional product approvals in order to provide surgeons in Japan with a full range of our spine fixation solutions.”
Healthcare market research firm GlobalData has projected the spinal fusion market to be valued at $684m by 2020 in Japan.