FDA Clears OrthoSensor Knee Surgery Monitoring Device

Sunrise, Fla.-based OrthoSensor Inc. has been granted 510(k) clearance from the U.S. Food and Drug Administration for the Verasense knee system with limb alignment. Verasense is an intraoperative instrument system that combines quantifiable data on limb alignment, implant position and soft-tissue balancing for surgeons during total knee replacement surgery.

According to OrthoSensor, the Verasense knee system is a single-use instrument system that replaces the standard plastic tibial trial spacer used during knee replacement surgery. Verasense uses proprietary sensor and communications technologies to give surgeons real-time feedback on limb alignment, implant position and soft tissue balance during knee replacement, according to the company. The goal is to enable surgeons to make evidence-based decisions regarding component placement, limb alignment and soft-tissue balance to improve clinical outcomes.

Verasense is compatible for use with multiple knee implant systems. The system enables surgeons to rapidly make a total kinetic (force and motion) assessment of knee function and make adjustments to achieve balance and stability through a full range of motion, claims the company.

“For the best patient outcomes, a knee must be both properly aligned and balanced; having the ability to quantify these two critical factors with one system is a major advance in total knee arthroplasty,” said Kenneth A. Gustke, M.D., of the Florida Orthopedic Institute. “Inaccurate limb alignment leads to long term wear problems; improper soft tissue balance leads to postoperative pain for patients, as well as instability, stiffness and dissatisfaction. Verasense is an accurate, simple and affordable solution to give knee replacement patients optimal short and long term clinical outcomes.”

“Traditionally, surgeons have relied on conventional instruments, personal judgment, and experience to assess soft tissue balance and limb alignment,” said Jay Pierce, OrthoSensor’s CEO. “Verasense advances surgeon decision-making from a feel-based art, to a quantifiable science with a low cost, easy to adopt solution that benefits all health system stakeholders and the patients they serve.”

OrthoSensor makes orthopedic devices that provide real-time data to surgeons and hospitals during and after surgery.