FDA approves 3D printed TOTAL ANKLE Patient-Matched Guides

The Food and Drug Administration (FDA) has provided 510(k) clearance for 3D Systems’ TOTAL ANKLE Patient-Matched Guides to be used with Smith+Nephew’s SALTO TALARIS Total Ankle Prosthesis and CADENCE Total Ankle System. The products feature individualized pre-surgical planning and a patient-specific 3D printed instrument set that ensures accurate implant alignment and sizing for tailored total ankle replacement surgery.

The collaboration between 3D Systems and Smith+Nephew, a medical technology company, achieved these patient-matched solutions that enable surgeons to prepare the bony anatomy of the tibia and talus for placement of implants intended to restore proper ankle joint function. These patient-matched guides are engineered and manufactured using 3D Systems’ VSP surgical planning solutions.

3D Systems’ personalized solutions are designed to enable surgeons to capitalize on benefits such as fewer procedural steps, shorter operating room (OR) time, and less intraoperative x-ray radiation, compared to procedures using standard non-patient-specific instruments.

“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,” said Ben Johnson, Vice President of Portfolio and Regulatory at 3D Systems.

“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 for Global Orthopedics at Smith+Nephew. “This advanced system is designed to offer unparalleled efficiency and accuracy, ultimately enhancing the overall experience for both surgeons and patients.”

3D Systems has manufactured more than 2 million medical device implants and supported over 100 FDA-cleared and CE-marked devices. 3D Systems’ 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 craniomaxillofacial applications to other parts of the human skeleton such as large joints. Additionally, the company sees tremendous opportunity for its solutions in trauma environments where both quality and response time are extremely important to patient outcomes.

“3D Systems is a recognized leader in supporting the medical device industry and surgeon community with early adoption in craniomaxillofacial procedures,” said Gautam Gupta, General Manager and Senior Vice President of Medical Devices at 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.”