Orthofix entered the Japan market with launch of its PHOENIX® Minimally Invasive Spinal Fixation System, following regulatory approval from the Japanese Ministry of Health, Labor and Welfare.
PHOENIX supports percutaneous pedicle screw placement to assist fusion in cases of degenerative disc disease, spinal stenosis and trauma conditions, and is designed for implantation via percutaneous and mini open surgical approaches.
Sources: Orthofix International N.V.
Other recent activity in this geographic region, which is considered to be the world's second-largest spine market and the largest general medical device market outside of the U.S., include:
- Globus Medical's entrance into Japan with its acquisition of Alphatec Spine's ex-U.S. operations
- OrthoPediatrics' Japan regulatory clearance for the RESPONSE Spine System for use in pediatric and adult patients
- Histogenics' acquisition of rights to NeoCart autologous cell therapy for the Japanese market
- Regulatory approval of Cytori Cell Therapy™
- NuVasive's regulatory approval of the ReLine™ Posterior Fixation
Sources: ORTHOWORLD Inc.