Canada-based orthopaedics developer Bodycad has secured 510(k) clearance from the US Food and Drug Administration (FDA) for the commercial launch of its personalised orthopaedic restoration Bodycad unicompartmental knee system.
The restoration is a joint reconstruction implant system based on proprietary 3D rendering of anatomical medical images. The unicompartmental knee system will optimise personalised restoration of anatomical features and kinematics.
Bodycad's founder and chief executive officer (CEO) Jean Robichaud said: "Our proprietary software is based on 20 years of research in anthropometric data and is the first computer aided design (CAD) / computer aided manufacture (CAM) software specifically developed for the personalisation 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 customisation to optimise patient care."
The personalised restoration process is expected to cause less trauma to the soft tissue and enable overall faster recovery of a patient.
While the firm's imaging algorithms rapidly generate an accurate 3D image of the patient's knee, the suite of personalised restoration software allows integration of the image to implant through a process called the personalised restoration evaluation process (PREP).
Designed to enhance patient satisfaction along with the economic quality metrics, the restoration process is claimed to be rapid and efficient.
Image: The Bodycad Unicompartmental Knee System. Photo: courtesy of PRNewsFoto/Bodycad.