restor3d has received U.S. Food and Drug Administration (FDA) 510(k) clearance for its Ossera AFX ankle fusion system, which features cutting-edge 3D printing and TIDAL technology.

The company will highlight the newly FDA-cleared system among other foot and ankle innovations at the American College of Foot & Ankle Surgery (ACFAS) annual meeting this week. Ossera was engineered for optimized osseointegration and biomechanical stability and become commercially available in May 2025.

“We understand that every surgeon has unique preferences and approaches when it comes to patient care,” said Ken Gall, chief commercial officer at restor3d. “That’s why we offer a comprehensive array of personalization options—ranging from standard implants with advanced design features to fully patient-specific solutions—allowing each surgeon to select the right level of customization to best fit their practice and patient needs. Our goal is to ensure that every surgeon has access to the right tools to achieve the best possible outcomes.”

In addition to Ossera, the company plans to highlight several other technologies at ACFAS 2025:

• Kinos total ankle system: a personalized total ankle arthroplasty solution engineered for stability, precision, and surgical efficiency.
• Ossera wedge family: an array of geometries for corrective foot and ankle procedures like Cotton & Evans osteotomies and subtalar distraction arthrodesis. Ossera wedges were designed to remove graft failure concerns.
• MTP hemiarthroplasty: a bone sparing implant system with streamlined instrumentation.