The U.S. Food and Drug Administration has granted 510(k) clearance (K260206) for SkeletonPlanner, Presurgeo's cloud-based surgical planning software for lower extremity alignment analysis and preoperative osteotomy planning.
FOR IMMEDIATE RELEASE
Presurgeo (Uplanner B.V) today announced that the U.S. Food and Drug Administration (FDA) has granted 510(k) clearance (K260206) for SkeletonPlanner, its cloud-based surgical planning software for lower extremity alignment analysis and preoperative osteotomy planning. This marks a significant milestone in the company's mission to enhance stroke care in the United States.
About SkeletonPlanner
SkeletonPlanner assists radiologists and orthopedic surgeons in analyzing lower extremity alignment and planning corrections of femoral and tibial bone deformities in adult patients. Integrated into the clinical workflow, the software reconstructs 3D bone models from CT scans using deep learning segmentation, automatically identifies anatomical landmarks, calculates alignment angles, and generates osteotomy planning recommendations. Every plan is reviewed, customized, and confirmed by the treating clinician.
A milestone for Presurgeo
"This clearance is a major milestone for Presurgeo and, more importantly, for the physicians and patients that will benefit from SkeletonPlanner," said Jessica Adams, CEO of Presurgeo.
Next steps
With FDA clearance in place, Presurgeo will begin making SkeletonPlanner available to U.S. hospitals and clinics.
About Presurgeo
Presurgeo, based in Amsterdam, the Netherlands, develops cloud-based software that helps clinicians plan orthopedic procedures with greater speed and precision. SkeletonPlanner is FDA 510(k) cleared (K260206) for use by licensed radiologists and orthopedic surgeons in hospital and clinical environments.
Media Contact
Info@presurgeo.com