XpandOrtho earned FDA clearance for its electronic soft tissue balancing instrument.
Here are six points:
1. The instrument is designed for total knee replacement.
2. The sterile-packed wireless disposal device leverages miniaturized sensors and actuators to perform multiplanar balancing of the knee joint.
3. Via a constant pressure bellows system, the device offers dynamic multiaxial balance and selection of optimal thickness of the tibial component.
4. XpandOrtho emphasizes surgeons may use the device no matter if they make the femoral or tibia cut first.
5. A La Jolla, Calif.-based Scripps Clinic clinical study on the product is underway.
6. XpandOrtho will initiate a limited release of the instrument.