Home Applications & Case Studies restor3d receives FDA approval for Axiom PSR system

restor3d receives FDA approval for Axiom PSR system

Medical device company restor3d has announced that the U.S. Food and Drug Administration (FDA) has granted 510(k) clearance for the Axiom PSR System for use with the company’s Kinos Axiom Total Ankle System. The Axiom PSR (patient-specific resection) system is additively manufactured from titanium alloy.

The Axiom PSR System is designed in collaboration with surgeons* to achieve individual surgical goals. It offers precision, accuracy and efficiency for procedures across the entire ankle joint. The 3D-printed metal templates provide an ideal anatomical fit and precise placement of the Kinos Axiom Total Ankle System implants. The design is designed to reduce surgical time in total ankle surgeries.

“The Axiom PSR metal resection guides sit noticeably better on the bone and offer greater saw control compared to the historically polymer patient-specific instruments. The ability to place the PSR on the bone, confirm via x-ray and cut through the guide gives me greater confidence in reproducible cuts for Total Ankle procedures and reduces time for me in the OR,” said John Lewis, MD of Louisville Orthopaedic Clinic in Louisville, Kentucky.

The Axiom PSR guides offer proprietary surface topography for added stability at the bone contact surface. The all-metal resection guides also feature integrated radiographic markers and a limited footprint that minimizes soft tissue disruption.

Brian Garvey, SVP of Product Development at restor3d commented, “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.”

The Axiom PSR system will be launched in April and will be fully available in June 2023. It complements restor3d’s existing portfolio, which already includes the Kinos Axiom Total Ankle System, the TIDAL Osteotomy Wedge Systems, the MTP Hemiarthroplasty System and the mobile app for the r3id Personalized Surgery platform.

Find out more about restor3D at restor3d.com.

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