Smith+Nephew/3D Systems
3D printed tibia guide
The FDA has provided 510(k) clearance for a new 3D printing-enabled pre-surgical planning and tooling set, which aims to improve efficiencies in total ankle replacement surgery.
The TOTAL ANKLE Patient-Matched Guides used with Smith+Nephew’s Total Ankle replacement solution are the result of a collaboration between 3D Systems and UK-founded medical equipment manufacturer Smith+Nephew, designed to save time and ensure accuracy during surgery. It includes customised pre-surgical planning and patient-specific 3D printed instruments that ensure accurate implant alignment and sizing for tailored total ankle replacement surgery. Ben Johnson, 3D Systems’ vice president, portfolio & regulatory, said the company’s biomedical expertise, selective laser sintering technology, and DuraForm ProX PA materials were “instrumental in the success of this program within a short timeframe.”
“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.”
To date, 3D Systems is said to have manufactured more than 2 million medical device implants and supported over 100 FDA-cleared and CE-marked devices. Earlier this year, for example, it achieved FDA 510(k) clearance for 3D printed PEEK cranial implant, which is said to save up to 85% less material compared to similar implants produced by traditional machining. These latest guides are engineered using the 3D printing company's VSP surgical planning solutions, which combine medical image processing, surgical planning, and additive manufacturing.
Gautam Gupta, Ph.D., general manager and senior vice president, medical devices, 3D Systems added, “Over the last several years, we have continued to leverage our VSP surgical planning workflows to expand into other personalised total joint orthopedic applications like shoulders and ankles.
“This is yet another great example of how our personalised orthopedics business continues to grow.”
