07.30.12
Plymouth Meeting, Pa.-based Maxx Medical has received approval from China’s State Food and Drug Administration (SFDA) for its Freedom Total Knee System. The device is a complete primary knee replacement said to have high flexion, and is specifically designed to address the need for smaller sized and differently proportioned implants that better support Asian lifestyle and physiology. According to Maxx Medical, it is the only artificial knee system designed that way that is sold globally.
The Freedom Knee features smaller transitional sizing options, so that surgeons can better customize fit according to patient size and stature. The high flexion is meant to support the deep knee bending and range of motion needs of Asian patients, with an all-poly tibial component specifically designed for high flexion and approved by the U.S. Food and Drug Administration (FDA). The knee is also designed to allow surgeons to preserve more bone stock in order to better preserve patients’ long-term mobility. This is especially important for Asian patients who tend to have less bone stock than their western counterparts.
“We’re excited to bring the benefits of Freedom Knee to surgeons and patients throughout China. There was a need for new joint replacement solutions developed to accommodate population-specific nuances, particularly in Asia, where retro-fit western implant systems were the only options,” said Ashesh Shah, CEO of Maxx Medical. “We’ve already seen the dramatically improved mobility in patients throughout the Middle East and South Asia that Freedom Knee has enabled, and are confident that Chinese patients suffering from knee pain will equally benefit.”
Launched in 2009, Freedom Knee recently received the Frost & Sullivan “Product Differentiation Excellence Award in Orthopedic Knee Joint Replacement.” In addition to SFDA approval, Freedom Knee has FDA, Drugs Controller General of India and European CE Mark approvals. Freedom Knee is manufactured in the United States, while the company also has locations in India and Singapore.
The Freedom Knee features smaller transitional sizing options, so that surgeons can better customize fit according to patient size and stature. The high flexion is meant to support the deep knee bending and range of motion needs of Asian patients, with an all-poly tibial component specifically designed for high flexion and approved by the U.S. Food and Drug Administration (FDA). The knee is also designed to allow surgeons to preserve more bone stock in order to better preserve patients’ long-term mobility. This is especially important for Asian patients who tend to have less bone stock than their western counterparts.
“We’re excited to bring the benefits of Freedom Knee to surgeons and patients throughout China. There was a need for new joint replacement solutions developed to accommodate population-specific nuances, particularly in Asia, where retro-fit western implant systems were the only options,” said Ashesh Shah, CEO of Maxx Medical. “We’ve already seen the dramatically improved mobility in patients throughout the Middle East and South Asia that Freedom Knee has enabled, and are confident that Chinese patients suffering from knee pain will equally benefit.”
Launched in 2009, Freedom Knee recently received the Frost & Sullivan “Product Differentiation Excellence Award in Orthopedic Knee Joint Replacement.” In addition to SFDA approval, Freedom Knee has FDA, Drugs Controller General of India and European CE Mark approvals. Freedom Knee is manufactured in the United States, while the company also has locations in India and Singapore.