XpandOrtho announces FDA 510(k) clearance for soft-tissue balancing electronic device for TKA

XpandOrtho Inc. received FDA 510(k) clearance for its electronic instrument to balance soft tissue in total knee replacement surgery, according to a company press release.

The device uses multiple miniaturized sensors and actuators to perform multiplanar balancing of the knee joint in a full range of motion. The sterile-packaged disposable device uses a novel, constant pressure bellows system that wirelessly communicates with the display to offer dynamic multiaxial balance and selection of optimal thickness for the tibial component. The device provides real-time visual feedback to the surgeon for soft tissue release. It is reportedly compatible with most total knee implant systems from major manufacturers. The device can also reportedly save an electronic record of the 3-D balance of the knee at the end of the procedure.

“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,” Clifford Colwell, MD, president and chairman of the board for XpandOrtho Inc., said in the release.

XpandOrtho has begun a clinical study on the device at the Scripps Clinic in La Jolla, California and will offer a limited release of the device to select surgeons in the United States.

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