Medical device firm restor3d has received 510(k) clearance from the US Food and Drug Administration (FDA) for its Axiom patient-specific resection (PSR) system for use with its Kinos Axiom Total Ankle System.

The company produces the Axiom PSR system from titanium alloy using an additive manufacturing process.

restor3d product development senior vice president Brian Garvey said: “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.

“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.”

With the clearance, Axiom PSR is claimed to be the first all-metal, patient-specific instrument system approved for use with an ankle arthroplasty system.

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The system, which is designed in partnership with the operative surgeon to meet each patient’s unique surgical needs, is expected to offer precision, accuracy, and efficiency for total ankle procedures.

To maintain stability at the bone contact interface, the Axiom PSR guides integrate an advanced surface topography.

It also features integrated radiographic markers for fluoroscopic visualisation and has a limited footprint to reduce soft tissue disruption.

Part of the company’s lower extremity portfolio, the Axiom PSR system incorporates TIDAL Technology’s interconnected porosity.

Other products in the portfolio include the TIDAL Osteotomy Wedge Systems and MTP Hemiarthroplasty System, and the Kinos Axiom Total Ankle System.

Furthermore, the company offers a mobile companion app for the r3id personalised surgery platform.