A new bioabsorbable orthopedic fixation implant received FDA 501(k) clearance yesterday, and it could be a gamechanger for both patients and surgeons. Ossio, the parent company behind the device, says it expects their Ossiofiber bone pins to be launched in the United States in the second quarter of this year.
The fixation device is made of what the company describes as a “mineral fiber matrix,” and Ossio views it as an alternative to permanent fixation hardware. The unique design of the bioabsorbable implant means that the material actually integrates into the surrounding foot and ankle anatomy in about two years. Right now the company is focused on launching it’s foot and ankle fixation devices in the second quarter of 2019, but down the road they hope to develop implantable bioabsorbable devices that can help with things like:
- Distal extremity surgeries
- Significant trauma injuries
- Sports injuries
- Reconstruction injuries
- Pediatric surgeries
- Spinal segments
Why Bioabsorbable?
According to medical statistics, ankle fractures are the fifth most common type of bone fracture, accounting for about nine percent of all fractures in the human body. That means more than 250,000 Americans are suffering ankle fractures each year, and about a quarter of them will require surgery to address the fracture.
Currently, metal implants are considered the standard of care when it comes to orthopedic fixation, but it’s far from a perfect system. The bone doesn’t always heal properly when metal or other hardware is implanted, and other complications like infection or allergic reaction are also possible. In other cases, the metal implant can be felt under the skin, and while it may not be painful, it can cause some discomfort.
Others have tried to develop a bioabsorbable implant device, but the current devices can release byproducts that lead to an increase in inflammation at the surgery site. They also have failed to provide the same strength and support as metal implants. According to Ossio’s claims, they have created a bioabsorbable implant that is actually stronger than bone, but it is also unique in that it can integrate with the native anatomy of a person’s foot. Best of all, it can be implanted using the same current surgical techniques used during metal hardware insertion.
“An implant that maintains its strength through the known healing timeline, and is then completely integrated into the surrounding anatomy with no adverse inflammation is a real breakthrough for surgeons and the patients we treat,” Stuart Miller, orthopaedic surgeon at MedStar Union Memorial Hospital and assistant professor at Johns Hopkins University School of Medicine, said in a press release.
So far the device has received clearance for use in alignment and fixation surgeries to address bone fractures, osteotomies, arthrodesis and bone grafts.
We’re always looking for the next medical innovation, so we’re going to keep a close eye on this implantable device. Assuming all continues to go well, it may soon make its way into our operating room!