FDA 510(k) Clearance for kneeEOS 3D Surgical Planning Software for TKA

EOS imaging, a provider of 2D/3D orthopedic medical imaging, has announced that the company received a 510(k) clearance from the U.S. Food and Drug Administration (FDA) to market kneeEOS software in the United States. The kneeEOS online 3D planning software utilizes weight-bearing 3D images and data from the EOS system to provide an optimized surgical plan for Total Knee Arthroplasty. The software makes an initial automatic proposal for the size selection and position of the implant components to facilitate surgical preparation and optimize the alignment in 3D while displaying relevant clinical parameters in real time.
 
The clearance of kneeEOS completes the company’s current portfolio of EOSapps dedicated to the most common orthopedic surgeries. The EOSapps are based on a patient’s 2D images and 3D digital anatomical dataset obtained from an EOS exam. EOS exams are performed at each step of the patient care continuum including diagnosis, pre-operative planning, post-operative assessment and follow-up.
 
Marie Meynadier, CEO of EOS imaging, said, “The kneeEOS FDA clearance is an important milestone that allows us to offer our full set of software solutions to the U.S. market. It will support the growing adoption of EOS images, 3D models and patient-specific datasets at each step of the care continuum, helping healthcare providers bring the value of personalized treatments to their patients without the high dose and cost of CT imaging.”