FDA Approves 3D Systems’ Orthopedic Patient-Specific Guides for Ankle Replacements

3D Systems has received the Food and Drug Administration (FDA) 510(k) clearance for 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 presurgical planning and a patient-specific 3D printed instrument set that is said to ensure accurate implant alignment and sizing for tailored total ankle replacement surgery.

The collaboration between 3D Systems and Smith+Nephew 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 function of the ankle joint. These patient-matched guides are engineered and manufactured using 3D Systems’ VSP surgical planning solutions that combine digital workflows with one of the industry’s broadest additive manufacturing (AM) portfolio of printers and materials.

3D Systems’ personalized solutions are designed to enable surgeons to capitalize on benefits such as performing the operation with fewer procedural steps, shorter operating room (OR) time and less intraoperative X-ray radiation compared to procedures using standard nonpatient-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,” says Ben Johnson, 3D Systems’ vice president, portfolio and regulatory. “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 time frame.”

Smith+Nephew is now partnering with 3D Systems to unveil its new Total Ankle Patient-Matched Guides for total ankle replacement. “(It’s) a breakthrough to help transform the way health care professionals approach surgical precision and improved patient outcomes,” says Mark McMahan, vice president of marketing, 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 been a pioneer in the personalized medicine space. The company has manufactured more than 2 million medical device implants and supported more than 100 FDA-cleared and CE-marked devices. The company’s 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 says its AM solutions are helping to drive innovation in the global orthopedic devices market which is growing at a CAGR of 11.2% and is anticipated to reach $5.3 billion by 20233.

“3D Systems is a recognized leader in supporting the medical device industry and surgeon community with early adoption in craniomaxillofacial procedures,” says 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.”