The FDA has awarded 510(k) clearance to OrthoSensor, Inc. for its Verasense Knee System with limb alignment, according to a company release. The company says that Verasense is the first intraoperative instrument system to combine quantifiable data on limb alignment, implant position and soft tissue balancing for surgeons during total knee replacement surgery.
OrthoSensor describes its knee system as a low-cost, single-use instrument system that replaces the standard plastic tibial trial spacer used during knee replacement surgery. It says that it utilizes proprietary sensor and communications technologies to give surgeons real-time feedback on limb alignment, implant position and soft tissue balance during knee replacement.
“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., 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.”
“OrthoSensor’s intelligent orthopedic technology has taken knee replacement surgery to a new level of precision that enables improved patient care, ” said Jay Pierce, OrthoSensor’s CEO. “Traditionally, surgeons have relied on conventional instruments, personal judgment, and experience to assess soft tissue balance and limb alignment. 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, ” he said. The company reports that its newly approved system has been adopted by over 35 orthopedic centers in the U.S.
