Fact checked byGina Brockenbrough, MA

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September 15, 2024
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3D Systems, Smith & Nephew announce FDA clearance for total ankle replacement solution

Fact checked byGina Brockenbrough, MA
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Key takeaways:

  • 3D Systems announced FDA clearance of its total ankle patient-matched guides for use with the total ankle platforms from Smith & Nephew.
  • The collaboration offers a solution for personalized ankle replacement.

3D Systems announced FDA 510(k) clearance of its total ankle patient-matched guides for use with the Salto Talaris total ankle prosthesis and the Cadence total ankle system from Smith & Nephew, according to a company press release.

“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,” Gautam Gupta, PhD, general manager and senior vice president of medical devices at 3D Systems, said in the release. “This is yet another great example of how our personalized orthopedics business continues to grow.”

Generic FDA News infographic
3D Systems announced FDA clearance of its total ankle patient-matched guides for use with the total ankle platforms from Smith & Nephew.

The combination of platforms from 3D Systems and Smith & Nephew will offer surgeons a complete solution for personalized total ankle replacement with 3D-printed instruments, according to the release.

“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 health care professionals approach surgical precision and improved patient outcomes,” Mark McMahan, vice president of marketing for global orthopedics at Smith & Nephew, said in the release. “This advanced system is designed to offer unparalleled efficiency and accuracy, ultimately enhancing the overall experience for both surgeons and patients.”

According to the release, 3D Systems and Smith & Nephew will feature the systems at the American Orthopaedic Foot and Ankle Society Annual Meeting from Sept. 11-14.