Brisbane-based medical innovator Field Orthopaedics has reached a significant milestone with a sterile version of its NX Nail implants officially cleared for distribution in the United States of America by the Food and Drug Administration on 16 February 2023.
The NX Nail – a second-generation extremity nail designed predominately to treat hand fractures – was introduced to the US market on a limited basis in 2021 as a non-sterile system with implants and instrumentation available in reusable instrument trays. The new sterile implant offering will be launched into the US market, exclusively distributed by Medartis from Q2 2023.
Field Orthopaedics CEO Patryk Kania said this sterile offering was 12 months in the making and is an exciting step for the business. “We’re thrilled to receive 510(k) clearance in the US for our sterile NX Nail implants which will arrive to hospitals already prepared for surgery,” he said.
“Our team of specialists in Brisbane have been developing this product and preparing regulatory documentation since early last year. Now, we are looking forward to expanding our commercial footprint in the US market with this innovative product, which has been well received by early users.”
Mr Kania added that there were several benefits of using sterile implants which include product effectiveness, organizational efficiency, economic impact, and patient safety. “The positive impact on each hospital’s internal processes for the benefit of the patients is huge,” he said. “Inventory monitoring and resupplying is more efficient, and traceability is much easier to
Founded in 2015, Field Orthopaedics is based in Brisbane, Australia and includes a team of surgeons, engineers, scientists, and industry experts designing and delivering innovative hand solutions for patients around the globe.
For more information, visit https://fieldorthopaedics.com/products/nx-extremity-nails/.