U.S. FDA grants 510(k) clearance to Skyve for PNK artificial joint device

PNK artificial joint device [Courtesy of Skyve]

The U.S. Food and Drug Administration (FDA) granted the 510(k) clearance to a team of South Korean medical experts for an artificial joint device.

The device, called Preservation of Normal Knee Kinematics (PNK) Total Knee System, was jointly developed by a team of medical device startup Skyve Co. and Yonsei Sarang Hospital, a Seoul-based joint clinic.

The 510(k) is a premarket submission to demonstrate the medical device is safe and effective.

The PNK Total Knee System is different from conventional devices as it can bend up to 150 degrees to work well for Koreans who spend most of their time sitting at a desk or engaging in other sedentary lifestyles.

The manufacturer cited the FDA’s review, saying the PNK can achieve the maximum possible normal knee flexion angle using the data obtained from 12,305 patients.

Skyve further highlighted its success in creating an augmented reality (AR) system that integrates actual computed tomography (CT) and magnetic resonance imaging (MRI) images of patients undergoing artificial joint surgery with AR, aiming to enhance surgical precision and facilitate personalized procedures.

The Ministry of Food and Drug Safety in Korea approved the PNK Total Knee System prosthetic in April.