Restor3d has received approval from the Food and Drug Administration (FDA) 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 has a portfolio of various ankle implants. This development may contribute to the continued growth of the ankle replacement market, which was estimated to be worth $309.1m in 2022 and is anticipated to reach $618.7m by 2033, according to leading data and analytics company GlobalData.

New developments in the patient-specific instrumentation space are sure to bolster and push forward the joint replacement market. The approval of restore3d’s latest ankle arthroplasty product is indicative of a slight shift towards more customised surgeries, which are largely aided by advancements in 3D printing, as seen in the case of Axiom PSR.

Axiom PSR functions as the bone contact interface in order to maintain the joint’s stability and incorporates radiographic markers in order to make fluoroscopic imaging possible. Patient-specific instrumentation is developed in collaboration with an operative surgeon and manufacturer to help guide by collaborating with the operative surgeon the design process. It utilises pre-operative imaging in order to produce 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 Axiom PSR is not the first PSI in ankle arthroplasty, it is the first all-metal PSI. Specifically, Axiom PSR is made of titanium alloy, which means it will have better durability compared to implants made from ceramic or polyethene. While it is rare, one drawback of the material 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.

The ankle replacement market, which includes major players such as Stryker and Zimmer Biomet, is dominated by standard instrumentation, with PSI products making up just a small portion of the market. However, the benefits of a customised surgical implant are expected to continue to gain interest as more devices like Axiom PSR become commonplace in this market.

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