MedicalOrthopedic Implants

FDA approves first patient-specific, 3D printed talus implant in the US

Produced by Additive Orthopaedics

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The FDA has approved its first 3D printed talus metal implant designed to replace the main bone in the ankle joint connecting the leg to the foot. The agency issued a green light to New Jersey-based Additive Orthopaedics under humanitarian use for the treatment of avascular necrosis, a progressive condition that can lead to the death of bone tissue following a sudden injury that cuts off blood flow, such as a broken bone or dislocation.

The cobalt-chromium alloy implant is custom-made to match each patient’s talus bone using data taken from a CT scan. It’s designed to potentially spare them from other surgical procedures that may fuse ankle and foot bones together and leave the joint fixed in place.

 The 3D printed talus implant

“Avascular necrosis of the ankle, while a rare condition, is a serious and potentially debilitating one that causes pain and can lead to inhibited motion of the ankle joint, and in some cases, removal of part of the leg,”

FDA approves first patient-specific, 3D printed talus implant in the US
(Credits: Additive Orthopaedics, LLC.)

said Capt. Raquel Peat, Ph.D., of the U.S. Public Health Service and director of the FDA’s orthopedic device office.

“Today’s action provides patients with a treatment option that could potentially reduce pain, retain range of motion of their joint and improve quality of life,” Peat said.

The agency granted Additive’s talus spacer implant a humanitarian use exemption, offered for devices aimed at conditions that affect fewer than 8,000 people annually.

A clinical trial of 31 patients that received 32 replacement procedures—with one participant having operations on both ankles—found pain decreased over the three years following surgery. Three participants needed additional surgeries during that time, according to the FDA.

The company said it plans to begin the implant’s commercial launch immediately.

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Davide Sher

Since 2002, Davide has built up extensive experience as a technology journalist, market analyst and consultant for the additive manufacturing industry. Born in Milan, Italy, he spent 12 years in the United States, where he completed his studies at SUNY USB. As a journalist covering the tech and videogame industry for over 10 years, he began covering the AM industry in 2013, first as an international journalist and subsequently as a market analyst, focusing on the additive manufacturing industry and relative vertical markets. In 2016 he co-founded London-based 3dpbm. Today the company publishes the leading news and insights websites 3D Printing Media Network and Replicatore, as well as 3D Printing Business Directory, the largest global directory of companies in the additive manufacturing industry.

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