OrthoSensor Gains 510(k) Alignment Clearance for VERASENSE for use with Zimmer Biomet’s Persona Knee

By Julie A. Vetalice

OrthoSensor Gains 510(k) Alignment Clearance for VERASENSE for use with Zimmer Biomet’s Persona Knee

OrthoSensor received FDA 510(k) clearance for Alignment capabilities with VERASENSE™ Sensor-Assisted Technology to measure tibial coronal alignment and quantify soft tissue balance when used with Zimmer Biomet's Persona Knee.

VERASENSE is used with major knee implant systems during primary and revision total knee arthroplasty. The technology transmits real-time data to a display unit in the O.R., supporting informed decisions about soft tissue balance and implant alignment.

OrthoSensor has launched a reverse shoulder device, and seeks to expand to other orthopedic applications.

In a prospective multi-center study, VERASENSE use was proven to reduce post-operative pain, accelerate patient activity levels, improve functional outcomes and increase patient satisfaction scores with high statistical significance. Studies indicate that 98% of patients whose knees were balanced using VERASENSE reported that they were satisfied to very satisfied at three years post-op.

Dr. Martin Roche, Orthopedic Surgeon and Chief Medical Officer of OrthoSensor, said, "The ability to achieve optimal knee stability, implant congruency and alignment through the full range of motion is critical. The data that is provided from the single use VERASENSE sensor will enable surgeons at hospitals and ambulatory surgery centers to make objective assessments intraoperatively of soft-tissue balance and knee alignment with the Persona implant system for the best possible patient outcomes."

Product Labels: Knee Replacement

Tags: 510(k) Clearance, Regulatory