Zimmer Biomet Receives FDA Clearance for 3D Printed Ankle Fusion System

There’s so much that can go wrong with the joints – particularly the ones that carry our weight. The knees and ankles are strong but delicate at the same time, and problems with them can put you, quite literally, on the shelf for a long time. (Well, on the couch.) The foot and ankle bones are particularly delicate – and critical. One quarter of the bones in the human body are in the feet; each foot and ankle is home to 26 bones, 33 joints, and more than 100 muscles, tendons and ligaments. When bones or cartilage in the feet and ankles are damaged, they require a lot of specialized care.

One common foot and ankle surgical procedure is arthrodesis, commonly known as ankle fusion. It can be required for a number of reasons, most commonly fractures and arthritis. It tends to be a last resort in treating severe ankle pain, if treatments like braces and steroid injections have been insufficient. Basically, ankle fusion is exactly what it sounds like – the fusion of the ankle bones to create one connected bone, eliminating pain caused by the motion of the ankle.

It sounds painful, and it is – recovery typically takes 10 to 12 weeks, and patients have to adjust how they walk to accommodate the fused joint. Usually, screws and/or plates are used to hold the bones together, and they’re generally not removed after the bones have fused, except in the case of irritation or infection. Sometimes bone grafts are required. Bone grafts in themselves are tricky and often painful, but researchers are coming up with ways to significantly improve them using 3D printing. Now the FDA has approved a new system that uses 3D printing to improve arthrodesis procedures.

Reconstructive wedges made from OsseoTi

Zimmer Biomet is a global leader in reconstructive orthopedics. Their Unite3D Bridge Fixation System removes the need for the plates, screws and staples used in traditional arthrodesis, instead relying on a 3D printed “osteoconductive matrix designed to provide for biological incorporation.” Out of the many ways that 3D printing has affected implants of all kinds, one of the most important is the ability to create implants made from biocompatible materials that can be absorbed into the body or that mimic the properties of the body’s natural structures. The Unite3D system, which was developed with help from orthopedic surgeons Dr. Greg Pomeroy of New England Foot and Ankle Specialists and Dr. John Early from Texas Orthopaedic Associates, utilizes Zimmer Biomet’s proprietary OsseoTi material, a porous metal that mimics the structure of cancellous (spongy) bone.

“By offering foot and ankle surgeons a construct for osseointegration across the entire fusion site, the Unite3D Bridge Fixation System provides a stable and durable solution for fracture and osteotomy fixation and joint arthrodesis within the midfoot and hindfoot,” said Dr. Early. “Having replaced the plates, screws and surgical staples of traditional foot and ankle fusion, we also wanted to offer the intraoperative benefits of a streamlined procedure with easy-to-use and disposable surgical instruments.”

Because arthrodesis procedures differ according to the reason for the surgery, as well as patient anatomy, the Unite3D Bridge Fixation System offers nine implant size options plus single-use surgical instruments. The internal framework of the implants is made to be extra strong and rigid, with a zero-prominence design and uniform compression along the entire length of the implant.

“The Unite3D Bridge Fixation System is unlike anything in our portfolio, and we are proud to commercialize a true innovation in this exciting clinical area,” said Ben Joseph, General Manager of Zimmer Biomet Foot and Ankle. “This powerful combination of 3D printing technology and our OsseoTi porous metal material is only the latest contribution from Zimmer Biomet’s robust innovation pipeline. We aim to serve the unique needs of patients and surgeons while expanding our presence in every category of musculoskeletal healthcare, including the rapidly growing market of foot and ankle treatments.”

Discuss in the Zimmer Biomet 3D Printed Medical Device forum over at 3DPB.com.