restor3d has received U.S. Food and Drug Administration (FDA) 510(k) clearance for its Axiom PSR (patient-specific resection) system for use with its Kinos Axiom total ankle system. restor3d gained the Kinos ankle replacement implant with its July 2021 merger with Kinos Medical.
 
Axiom PSR is additively manufactured from titanium alloy, which makes it the first all-metal, patient-specific instrumentation system cleared for use with an ankle arthroplasty system, according to the company. The instruments can be designed collaboratively with the operative surgeon based on each one’s unique surgical goals.
 
The all-metal resection guides are 3D printed at restor3d’s Durham, N.C. facility and aim to facilitate ideal anatomic fit and exact placement of the pre-planned cut needed to place the Kinos Axiom ankle implants. Streamlined designed features also aim to minimize operative time during 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,” John Lewis, MD of Louisville Orthopaedic Clinic in Louisville, Ky. told the press.
 
Axiom PSR guides also have a proprietary surface topography for added stability at the bone contact interface. The all-metal resection guides also include integrated radiographic markers for fluoroscopic visualization and a limited footprint to reduce disruption of soft tissue.
 
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.”
 
Axiom PSR began initial release in April and the company anticipates full launch in June.