If you’re a frequent reader of this blog, you’re probably somewhat familiar with OSSIO, Inc. and their bone regeneration technology. We’ve profiled the company a few times in the past, including in January when Dr. Silverman performed the first surgery in Minnesota using OSSIOfiber technology. The fiber is twice as strong as traditional non-fixation devices, and the fiber eventually naturally incorporates with a person’s bone, meaning there’s no need for a hardware removal operation.
OSSIO is in the news again, this time for earning 510(k) market clearance from the U.S. Food and Drug Administration for their OSSIOfiber Compression Screw Portfolio. The screws can be used to treat a number of injuries, including the alignment and fixation of:
- Bone fractures
- Comminuted fractures
- Fragmentation
- Osteotomies
- Arthrodesis
- Bone grafts
New OSSIOfiber Integrative Screw
The bio-integrative implant is the only compression screw on the market that is both strong enough to provide for stable bone fixation and designed such that it eventually integrates with the bone without adverse foreign body reactions or stress shielding. By integrating into the bone, the patient doesn’t have to worry about long-term hardware discomfort or related complications. Previous studies have shown that the screws can provide for easy insertion and secure fixation with rapid bone attachment in as little as two weeks following surgery, and they lead to gradual bone incorporation within as little as 18-24 months.
To this date, more than 1,000 OSSIOfiber implantations have been successfully performed in the US, and that number will only continue to climb, especially in the wake of the market clearance for their screws. The company plans to commercially launch the screws in early 2021 and add more lengths and diameters to their portfolio in the near future.
I personally cannot wait to provide my patients with this option for their surgeries if they are an ideal candidate. It will make such a difference in their care, and I expect roughly 25 percent of patients will now be able to undergo a fixation procedure with hardware insertion without needing to undergo a subsequent hardware removal operation in the future. Hardware removal can be a very tricky procedure, so eliminating the need for the removal could be a gamechanger for both patients and surgeons. I’m excited to implement this product in the near future.