FDA Clears Bodycad’s Personalized Unicompartmental Knee System

Bodycad announced it has received U.S. Food and Drug Administration (FDA) 510(k) clearance for its Bodycad Unicompartmental Knee System, enabling the commercial launch of this truly personalized orthopaedic restoration. Bodycad is the first Canadian company to receive FDA clearance for a joint reconstruction implant system.
 
Bodycad’s revolutionary Unicompartmental Knee System is designed to optimize personalized restoration of the patient’s unique anatomical features and kinematics. The system is based on proprietary 3D rendering of medical images of the patient’s anatomy. The restoration is delivered as a “procedure in a box” that completely revolutionizes the way orthopedic implant and instrument applications are delivered and utilized in the operating room environment.
 
“The personalized restoration is created only after proper acquisition of data from the patient on an individualized level,” said Etienne Belzile, MD, orthopedic surgeon and assistant professor at Laval University. “The benefit of personalized restoration is the possibility of a better fit to the individual, less trauma to the soft tissue, and potentially a faster recovery overall.”
 
Bodycad uses proprietary imaging algorithms to rapidly produce a precise 3D image of the patient’s knee. Its suite of Personalized Restoration Software enables a seamless integration of the image to implant process called the PREP (personalized restoration evaluation process). The efficient and rapid process is designed to increase patient satisfaction while improving economic quality metrics.
 
“Our proprietary software is based on 20 years of research in anthropometric data and is the first CAD/CAM software specifically developed for the personalization of orthopedic implant and instrument design,” said Jean Robichaud, founder and CEO of Bodycad. “I am delighted to have FDA clearance to bring this important technological advancement to market. Our goal is to transform the way surgeons, patients and insurers think about the potential of mass customization to optimize patient care.”