The novel bio-integrative implants with disposable and sterile instrumentation are available in three sizes
The US FDA’s Center for Devices and Radiological Health (Credit: The U.S. Food and Drug Administration)
Orthopaedic fixation company OSSIO has secured 510(k) clearance from the US Food and Drug Administration (FDA) for its OSSIOfiber hammertoe fixation system.
The approval has been granted for the system that enables the maintenance of alignment and fixation of bone fractures, osteotomies, arthrodesis and bone grafts.
The new bio-integrative implants with disposable and sterile instrumentation are available in three sizes. With both straight and angled configurations, the implants will facilitate customisation among various patient anatomies.
The OSSIOfiber hammertoe fixation system features OSSIOfiber intelligent bone regeneration technology, a new category of fixation material that aggregates mechanical strength and natural bone healing in a non-permanent implant.
The system is produced by using natural mineral fiber matrix, and its bio-integrative material properties help surgeons to restore patient stability and mobility.
In 2019, the company completed the recruitment of patients in its European multi-centre clinical study, which was designed to evaluate the safety and performance of the OSSIOfiber hammertoe fixation system.
According to the company, the study results showed fusion rates well above historical literature, significant improvements in pain and quality-of-life scores from baseline, radiographic evidence of good bio-integration with the surrounding anatomy and no adverse biological response or serious adverse events with the OSSIOfiber implant at six months follow-up.
OSSIOfiber intelligent bone regeneration technology supports quick bone in-growth, regeneration and replacement
Developed to support quick bone in-growth, regeneration, and replacement, OSSIOfiber intelligent bone regeneration technology will help solve multiple surgical applications via different implant designs, including nails, screws, anchors and plates.
The firm aims to use the technology in various applications in distal extremity, trauma, sports, reconstruction, paediatrics, and spine segments.
OSSIO CEO Brian Verrier said: “With more than 500 successful hammertoe repairs conducted to date utilizing the OSSIOfiber Hammertoe Implant, along with the completion of our European multi-center study confirming the overall safety and positive performance of our proprietary technology, confidence in achieving excellent clinical outcomes and high surgeon and patient satisfaction continues to grow.”
In January 2019, the company first secured FDA 510(k) for OSSIOfiber Bone Pin family. In May same year, the company announced the US launch and first commercial use of OSSIOfiber Bone Pin family.