FDA Clearance for “Procedure in a Box” Uni Knee System

The Bodycad Unicompartmental Knee System has received U.S. FDA 510(k) clearance. Described as offering truly personalized orthopaedic restoration, Bodycad is the first Canadian company to receive FDA clearance for a joint reconstruction implant system.

Background

Aiming to optimize personalized restoration of the patient’s unique anatomical features and kinematics, Bodycad starts with precise 3D image of the patient’s knee. This proprietary 3D rendering of medical images of the patient’s anatomy feeds into a suite of Personalized Restoration Software that enables a seamless integration of the image-to-implant process called the PREP (personalized restoration evaluation process).

The restoration is delivered as a “procedure in a box” that completely revolutionizes the way orthopaedic implant and instrument applications are delivered and utilized in the operating room environment.

Bodycad says its efficient and rapid process is designed to increase patient satisfaction while improving economic quality metrics.

Physician comments

“The personalized restoration is created only after proper acquisition of data from the patient on an individualized level,” says Etienne Belzile, MD, orthopaedic 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.”

Company comments

“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,” says 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.”

Source: PR Newswire

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