restor3d Announces FDA Clearance of Ossera™ AFX Ankle Fusion System, Showcasing Innovations at ACFAS 2025
restor3d Announces FDA Clearance of Ossera™ AFX Ankle Fusion System, Showcasing Innovations at ACFAS 2025
DURHAM, N.C.--(BUSINESS WIRE)--restor3d, a leader in 3D-printed, personalized orthopedic implant care, will showcase its latest foot and ankle innovations at the American College of Foot & Ankle Surgery (ACFAS) Annual Meeting in Phoenix, Ariz., from March 27-30, 2025. Among the highlights is the newly FDA 510(k)-cleared Ossera™ AFX Ankle Fusion System, engineered to advance fusion procedures through cutting-edge 3D printing and TIDAL Technology™.
"Our goal is to ensure that every surgeon has access to the right tools to achieve the best possible outcomes."
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"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."
Featured Innovations at ACFAS 2025 with personalized offerings:
Ossera™ AFX Ankle Fusion System: Newly FDA 510(k) cleared, Ossera™ AFX is a breakthrough 3D-printed fusion system featuring TIDAL Technology™, engineered for optimized osseointegration and biomechanical stability. Available commercially in May 2025.
Kinos Total Ankle System: A fully personalized total ankle arthroplasty solution designed for precision, stability, and surgical efficiency, redefining what’s possible in total ankle replacement.
Ossera™ Wedge Family: An array of geometries for corrective foot and ankle procedures such as Cotton & Evans osteotomies and subtalar distraction arthrodesis. Featuring TIDAL Technology, Ossera™ wedges are engineered to eliminate graft failure concerns while providing an optimized design for osseointegration and biomechanical stability.
MTP Hemiarthroplasty: A bone sparing implant system with streamlined instrumentation designed for procedural efficiency.
Visit Booth #1030 to explore our cutting-edge implants and technology. For live updates during the conference, follow restor3d on LinkedIn.
Outside of the conference attendees are invited to an ACFAS Private Educational Dinner Event on Friday, March 28, at 6:45 PM, featuring presentations from Dr. Douglas Pacaccio, DPM, FACFAS, and Dr. Jason Miller, DPM. This session will explore real-world clinical cases and the latest advancements in patient-specific foot and ankle solutions.
Reserve your spot here: Registration Link
About restor3d, Inc.
restor3d is a world leader in 3D printed patient specific musculoskeletal implants and driven by the belief that every patient deserves personalized care. The company holds proprietary expertise and intellectual property in 3D printing of osseointegrative materials, AI-based planning and design automation tools, and digital health solutions to provide seamless data-backed care to optimize individual patient outcomes. Alongside its customers, restor3d is reimagining the musculoskeletal reconstruction landscape. More information is available at www.restor3d.com.
Forward Looking Statements
Certain statements made in this release that are not statements of historical or current facts are forward-looking statements which involve known and unknown risks, uncertainties and other factors that may cause the actual results, performance or achievements of the company to be materially different from historical results or from any future results or projections expressed or implied by such forward-looking statements. In many cases, forward-looking statements can be identified by terms such as “future,” “believes,” “expects,” “may,” “will,” “should,” “potential,” “estimates,” “intends,” “anticipates” or “plans” or the negative of these terms or other comparable terminology. Forward-looking statements are based upon management’s beliefs, assumptions and current expectations but are subject to known and unknown risks and uncertainties including, without limitation, distribution challenges, market trends and demand, product efficacy and safety concerns, product or raw material availability and other supply constraints. Although management believes that the expectations reflected in the forward-looking statements are reasonable, forward-looking statements are not, and should not be relied upon as a guarantee of future performance or results. The forward-looking statements included are made only as the date of this release. The company assumes no obligation to update any information or forward-looking statement contained herein, save for any information required to be disclosed by law.
Contacts
Jordan Wagner
Vice President of Marketing, restor3d
Phone: (281) 866-4988
Email: Jordan.Wagner@restor3d.com