restore3d recently received FDA approval for the first all-metal patient specific instrument (PSI) in ankle arthroplasty. This product, named Axiom PSR, will be added to Kinos Medical’s total ankle system, which hosts a portfolio of ankle implants. The development may contribute to the continued growth of the ankle replacement market, which was estimated to be worth $309.1 million in 2022 and is anticipated to reach $618.7 million by 2033, according to GlobalData, a leading data and analytics company.

Aidan Robertson, Medical Analyst at GlobalData, comments: “New developments in the patient-specific instrumentation space are sure to bolster and push forward the joint replacement market. With the approval of restore3d’s latest ankle arthroplasty product, there is a slight shift towards more customized surgeries, which are largely aided by advancements in 3D printing.”

The Axiom PSR functions as the bone contact interface in order to maintain the stability of the joint and incorporates radiographic markers to make fluoroscopic imaging possible.

Robertson continues: “Patient-specific instrumentation works by collaborating with the operative surgeon in the design process and utilizing pre-operative imaging in order to manufacture an implant that meets the unique surgical needs of each patient. Essentially, the main goal of patient-specific instrumentation is to enhance surgical accuracy compared to that of standard instrumentation.”

While the Axiom is not the first PSI in ankle arthroplasty, it is the first all-metal PSI, made using titanium alloy to provide durability compared to implants made from ceramic or polyethylene. Although rare, a drawback is that a small percentage of patients may have an allergic reaction to the titanium in the body, which would not make this a compatible product for all.

Robertson concludes: “Standard instrumentation still dominates the ankle replacement market with major players such as Stryker and Zimmer Biomet, whereas PSI products make up a small portion. However, it is expected that the benefits of a customized surgical implant will continue to gain interest as more devices like the Axiom PSR become common in the market.”