US-based medical device firm restor3d has received the US Food and Drug Administration (FDA) 510(k) clearance for use of its Axiom PSR (patient-specific resection) System with the company’s Kinos Axiom Total Ankle System.
The company has designed the Axiom PSR System using titanium alloy.
The Axiom PSR System is said to be the first patient-specific all-metal instrument approved for use with an ankle arthroplasty system.
Developed in partnership with the operative surgeon for each patient’s distinctive surgical goals, Axiom PSR System can offer precision, accuracy, and efficiency during total ankle procedures.
The system’s all-metal resection guides are 3d printed at restor3d’s plant in Durham, North Carolina, US.
According to the medical device company, the guides ensure perfect anatomic fit and exact placement of the pre-planned cut to place the Kinos Axiom Total Ankle System Implants.
The patient-specific resection system’s customised design intends to lower operative time during total ankle surgeries.
restor3d product development SVP 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 in-house 3d printing capabilities, advanced engineering, and clinically focused research teams allow us to provide 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 all-metal resection guides have a proprietary surface topography to maintain added stability at the bone contact interface.
Additionally, the Axiom PSR features an integrated radiographic marker for fluoroscopic visualisation and a small footprint which minimises soft tissue disruption.
The initial release of the patient-specific resection system is expected this month with full availability in June 2023.
The Axiom PSR System is the new member of the restor3d’s lower extremity range. The list already includes the TIDAL Osteotomy Wedge Systems, Kinos Axiom Total Ankle System and MTP Hemiarthroplasty System, and the mobile companion App for the r3id Personalised Surgery platform.
