The FDA handed OrthoSensor a 510(k) clearance for its Verasense knee system, designed to helps surgeons measure the proper placement and motion during total knee replacement procedures.
The Sunrise, Fla.-based device maker is touting the clearance as the 1st for a system that combines limb alignment and soft tissue-balancing features.
"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," CEO Jay Pierce in said prepared remarks.
OrthoSensor recently extended an agreement with the orthopedics giant Stryker (NYSE:SYK) for a cooperative marketing deal involving their knee surgical systems.
