3D Systems expands its portfolio for orthopaedic surgical planning and receives FDA approval

3D Systems announced that the Food and Drug Administration (FDA) has granted 510(k) clearance for the patient-specific TOTAL ANKLE Guides to be used with the SALTO TALARIS Total Ankle Prosthesis and Smith+Nephew‘s CADENCE Total Ankle System.

Ben Johnson, 3D Systems’ vice president, portfolio & regulatory, commented, “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. Our VSP surgical planning workflow including the expertise of our biomedical engineers, our Selective Laser Sintering technology, and our DuraForm ProX PA materials is a differentiator in the market and was instrumental in the success of this program within a short timeframe.”

The partnership between 3D Systems and Smith+Nephew, a global medical technology company, has developed an innovative solution that enables surgeons to prepare the bones of the tibia and talus specifically for the use of prostheses. This development is based on 3D Systems’ VSP planning technology, which combines digital workflows with a wide range of additive manufacturing solutions.

“We are excited to partner with 3D Systems and unveil our new TOTAL ANKLE Patient-Matched Guides for total ankle replacement — a breakthrough to help transform the way healthcare professionals approach surgical precision and improved patient outcomes,” said Mark McMahan, vice president of marketing, global orthopaedics at Smith+Nephew. “This advanced system is designed to offer unparalleled efficiency and accuracy, ultimately enhancing the overall experience for both surgeons and patients.”

A decisive advantage of these patient-specific guides is the reduction in the number of steps during the operation and the shortening of the operating time. In addition, the radiation exposure from X-rays during the procedure can be reduced. This could not only increase efficiency in the operating theatre, but also reduce stress for patients.

“3D Systems is a recognized leader in supporting the medical device industry and surgeon community with early adoption in craniomaxillofacial procedures,” said Gautam Gupta, Ph.D., general manager and senior vice president, medical devices, 3D Systems. “Over the last several years, we have continued to leverage our VSP surgical planning workflows to expand into other personalized total joint orthopedic applications like shoulders and ankles. Through our collaboration with an industry leader such as Smith+Nephew, we leveraged our collective expertise in orthopedics to develop an end-to-end solution for total ankle replacements that is helping surgeons perform surgeries more efficiently. This is yet another great example of how our personalized orthopedics business continues to grow.”

3D Systems’ VSP technology, originally developed for craniofacial surgery, is now being extended to other joint prosthesis applications. This emphasises the growing influence of 3D printing in orthopaedics.