FDA clears patient-specific resection for the Restor3d Axiom total ankle
07 Apr 2023
Durham, North Carolina-based Restor3d additively manufactures the Axiom PSR from titanium alloy. The company said this makes it the first all-metal, patient-specific instrumentation system cleared for use with an ankle arthroplasty system.
According to a news release, Restor3d designed the resection collaboratively with the operative surgeon for each patient’s unique surgical goals. The system consistently delivers precision, accuracy and efficiency in total ankle procedures, the company said.
This all-metal resection guides — 3D-printed at Restor3d’s Durham facility — ensure the ideal anatomic fit. They also offer the exact placement of the pre-planned cut required to place Kinos Axiom Total Ankle system implants. The streamlined design features aim to reduce operative time during total ankle surgeries.
Axiom PSR guides incorporate a proprietary surface topography. This ensures added stability at the bone contact interface. Additionally, it offers integrated radiographic markers for fluoroscopic visualization and a limited footprint. These benefits of all-metal resection reduce soft tissue disruption, Restor3d said.
The company plans for an initial release this month followed by full availability in June.
“It is very exciting to work on the team that obtained the first 510(k) clearance for an all-metal patient-specific arthroplasty instrument system,” said Brian Garvey, Restor3d SVP of product development. The convergence of our inhouse 3D printing capabilities, advanced engineering, and clinically focused research teams allows us to provide the next generation patient-specific devices.
“The Axiom PSR is an excellent addition to the Kinos Axiom Total Ankle portfolio, while also laying the groundwork for additional patient-specific development projects that we intend to launch in the near future.”
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