The U.S. Food and Drug Administration (FDA) awarded XpandOrtho 510(k) clearance for its sterile-packaged wireless disposable device that utilizes multiple miniaturized sensors and actuators to perform multiplanar balancing of the knee joint during a full range of motion. The device uses a novel constant pressure bellows system which wirelessly communicates with a display to provide dynamic multiaxial balance and selection of optimal thickness of the tibial component. The device can be conveniently used by all surgeons regardless of whether they choose to make the femoral cut first or the tibial cut first. Soft tissues can be released with the device in place enabling real time visual feedback to the surgeon. The “universal” design is compatible with almost all total knee implant systems from major manufacturers. This low-cost disposable device can also preserve an electronic record of the entire 3D balance of the knee at the end of the surgical procedure.
XpandOrtho has initiated a clinical study at Scripps Clinic, La Jolla, Calif. and will be conducting a limited release of their product to selected surgeons in the U.S. “We are excited to give large and small volume surgeons the ability to reproducibly and accurately balance the ligaments of the knee over a full range of motion during total knee replacement,” said Clifford Colwell, M.D., president and Chairman of the Board, XpandOrtho Inc.