3D Systems Receives FDA Clearance for Orthopedic Kit

Total Ankle Patient-Matched Guides engineered and manufactured by 3D Systems for use with Smith+Nephew’s Salto Talaris Total Ankle Prosthesis and Cadence Total Ankle System have received 510(k) clearance from FDA. The products feature individualized pre-surgical planning and a patient-specific 3D-printed instrument set that ensure accurate implant alignment and sizing for tailored total ankle replacement surgery.

The collaboration between 3D-printing technology pioneer 3D Systems and medtech company Smith+Nephew enables surgeons to prepare the bony anatomy of the tibia and talus for placement of implants intended to restore proper function of the ankle joint. The patient-matched guides are produced using 3D Systems’ VSP surgical planning solutions that combine digital workflows with a broad additive manufacturing portfolio of printers and materials, said 3D Systems in the announcement.

The personalized systems help surgeons save time and ensure accuracy. Fewer procedural steps are required and operating room time and intra-operative x-ray radiation are reduced compared with procedures using standard non-patient-specific instruments, said 3D Systems.

“With over 25 years of experience, our solutions have supported more than 175,000 patient-matched cases with the goal of improving surgical outcomes and the overall patient experience,” said Ben Johnson, 3D Systems’ vice president, portfolio & regulatory. “Our VSP surgical planning workflow, including the expertise of our biomedical engineers, our selective laser sintering technology, and our DuraForm ProX PA materials are differentiators in the market and were instrumental in the success of this program within a short time frame.” 

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3D Systems has manufactured more than two million medical device implants and supported over 100 FDA-cleared and CE-marked devices. Its VSP surgical planning solutions include a service-based approach to personalized surgery, combining expertise in medical image processing, surgical planning, and 3D printing. As 3D Systems’ technology has evolved over the last several years, the company is expanding its expertise beyond cranio-maxillo-facial applications to other parts of the human skeleton such as large joints. 3D Systems said it also sees opportunities in trauma environments, where both quality and response time are extremely important to patient outcomes.

The global orthopedic devices market is growing at a CAGR of 11.2% and is anticipated to reach $5.3 billion by 2032, according to a market report from Allied Market Research.

3D Systems and Smith+Nephew are showcasing the newly cleared guides in their respective booths at the American Orthopaedic Foot & Ankle Society (AOFAS) annual meeting from September 11 to 14, 2024, in Vancouver, BC.