XpandOrtho Receives FDA 510(k) Clearance for TKR Soft Tissue Balancing Instrument

By Julie A. Vetalice

XpandOrtho received FDA clearance for an electronic soft tissue balancing instrument for total knee replacement that is compatible with almost all total knee systems from major manufacturers.

Clinical study of the system is underway, and XpandOrtho will commence limited product launch to select U.S. surgeons. Future development may address its use in a range of orthopaedic procedures.

The sterile-packaged wireless disposable device uses multiple sensors and actuators to perform multiplanar balancing of the knee joint and communicate with a display system during full range of motion. Soft tissues can be released with the device in place, giving real time visual feedback to the surgeon. When the procedure is complete, the device preserves an electronic record of the entire 3D balance process.

OrthoSensor has also developed a disposable sensor system: VERASENSE. In 1Q16, the company entered into a strategic partnership with IM-Tech to support R&D collaboration, manufacturing and capital investments for global commercialization of the device. Also used in total knee arthroplasty, VERASENSE employs proprietary sensor and communications technologies to deliver data wirelessly to support evidence-based decisions on ligament/soft tissue balance and implant position in real time.

In early 2014, one-year results from a prospective multi-center evaluation of the VERASENSE Knee System indicated that patients with quantifiably balanced knees scored higher on pain and functional assessments and reported higher overall satisfaction vs. those with non-quantifiably balanced knees, with 97% reporting that they were satisfied to very satisfied.

Sources: XpandOrtho, Inc.; ORTHOWORLD Inc.

Product Labels: Knee Replacement

Tags: 510(k) Clearance, Regulatory