OrthAlign received 510(k) clearance from the FDA to market its UniAlign system.
Here are four notes:
1. The UniAlign system is the world's first handheld, single-use navigation device for unicompartmental knee arthroplasty surgeries.
2. UniAlign was developed using the same technology and platform as OrthAlign's clinically-proven KneeAlign technology.
3. UniAlign establishes the mechanical axis of the tibia, determining the varus/valgus angle and the posterior slope angle of the cutting block relative to the tibia, for the transverse resection.
4. It is expected that UniAlign will be commercially available in summer 2016.