FDA clears Bodycad’s personalized unicompartmental knee system

Canadian orthopedic developer Bodycad said today it won FDA 510(k) clearance for its Bodycad unicompartmental knee system and launched the device in the US.

The company said that the clearance makes it the 1st Canadian company to win FDA clearance for a joint reconstruction implant system.

“The personalized restoration is created only after proper acquisition of data from the patient on an individualized level. 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,” Dr. Etienne Belzile of Laval University said in a prepared statement.

Bodycad’s unicompartmental knee systems are personalized through the use of 3D renderings of medical images of the patient’s anatomy, the company said. The system uses proprietary imaging algorithms to create a precise 3D image of the patient’s knee and is delivered as part of a “procedure in a box,” Bodycad said.

“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 orthopaedic implant and instrument design. 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,” founder & CEO Jean Robichaud said in a press release.

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