Biointegrative orthopedic fixation material receives FDA clearance: 5 things to know

Shayna Korol -   Print  |

Orthopedic fixation company Ossio received FDA 510(k) clearance for its Ossiofiber Bone Pin Family.

Five things to know:

1. This technology features a proprietary biointegrative material designed to provide stability and secure bone fixation during the healing process. The Ossiofiber Intelligent Bone Regeneration Technology is intended to replace permanent fixation implants.

2. The platform's first commercial use is designed to treat forefoot conditions, which require hardware removal surgeries.

3. Initially, the implant's mechanical strength is intended to be significantly higher than that of cortical bone, and its performance supports bone regeneration throughout the healing process. It then transfers load to the native bone.

4. Full-integration into the surrounding anatomy occurs within approximately 18 to 24 months, leaving no residual hardware.

5. Ossio aims to launch the Ossiofiber Bone Pin Family in the U.S. in the second quarter.

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