EOS imaging: 510(k) for kneeEOS

EOS imaging, known for its 2D/3D orthopedic medical imaging, has announced the receipt of FDA 510(k) clearance to market kneeEOS software in the United States. Now, American surgeons can rely on this online 3D planning software to plan for total knee arthroplasty (TKA). Using weight-bearing 3D images and data from the EOS system, according to the November 7, 2016 news release, “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.”

Marie Meynadier, Ph.D., 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.”

Meynadier told OTW, “kneeEOS targets TKA and is the third surgical planning online software that the company has developed, after hipEOS for THA [total hip arthroplasty] and spineEOS for spine surgery, which was granted FDA approval earlier this year.”

“Challenges in TKA include proper alignment of the leg, which is currently done from planar radiographs that do not reflect properly torsion and flessum, particularly when associated with varus/valgus. kneeEOS utilizes 3D biplanar and 3D images to fully take into account the patient 3D anatomy in planning the component alignment.”