DURHAM, N.C.--(BUSINESS WIRE)--May 6, 2025--
restor3d, a leader in 3D printed, personalized orthopedic implant care, proudly announces the successful limited market release of the Aeros™ Modular Stem Total Ankle System, with five cases performed on launch day, May 5, 2025, at OrthoCarolina by renowned foot and ankle specialists Dr. Kent Ellington and Aeros design team member, Dr. Samuel Ford.
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The Aeros Modular Stem, the latest addition to the Kinos Total Ankle family, represents the first and only anteriorly inserted modular stem tibial implant available for Total Ankle Replacement (TAR). Cleared by the FDA for both primary and revision indications, the system enters a limited market release throughout 2025, with full commercial launch anticipated in 2026.
“We are exhilarated to see this system come to life in the OR with such a strong start,” said Dr. Samuel Ford. “The streamlined instrumentation and thoughtful design of the Aeros Modular Stem made for an efficient intraoperative experience, and it opens new doors for both primary and complex revision ankle arthroplasty cases.”
Designed for efficiency, versatility, and ease of use, the Aeros Modular Stem requires just three trays of procedure-specific instruments, compared to up to seven trays for competitive systems. The implant is inserted through a standard anterior TAR incision, avoiding violation of the heel, calcaneus, or subtalar joint—a key differentiator from other intramedullary systems. The refined instrumentation provides a hands-free working area for streamlined tibial canal preparation, with coupled and standalone Patient Specific Resection (PSR ™ ) Cut Guides providing greater intraoperative flexibility, particularly in complex deformity cases. Restor3D’s proprietary TIDAL Technology on all tibial and talar implants provides scientifically proven, research backed osseointegration potential, further emphasizing the role of the Kinos Total Ankle System in advancing total ankle arthroplasty.
The system is fully compatible with all existing Kinos Flat Cut Talus and bearing components, including its interchangeable Anatomic and Range articulations. In simulator testing, both articulating bearings demonstrated substantially improved polyethylene wear performance, with 200% less wear than Competitor A and 400% less than Competitor B¹. Competitors A and B were selected for comparison due to their length of time in the market and considerable clinical follow-up data presented in the literature. This advancement reflects the biomechanically accurate design of Kinos and directly addresses the growing demand for longer-lasting implants as survivorship rates improve.
Early retrospective studies are underway to validate an anticipated 30% reduction in operative time versus traditional stemmed systems—a meaningful objective given published data by Gross et al.², which links every 15-minute increase in TAR operative time with a 10% increase in complications, 33% increase in wound dehiscence, and 16% increase in reoperations.
“The Kinos Modular Stem system combines modularity, versatility, and simplicity in a way the TAR market has long needed,” added Dr. Ford. “This is a platform I’m confident will appeal to both experienced and new users alike.”
¹ Data on File
² As presented at AOFAS 2024 Annual Meeting “A Prospective Evaluation of a 4th Generation Total Ankle Prosthesis with Flat Cut vs Chamfer Cut Talar Component" 9/13/2024 Vancouver, British Columbia, Canada
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.
Drs. Kent Ellington, Sam Ford, and Scott Shawen, of OrthoCarolina Foot & Ankle Institute in Charlotte, NC were the first surgeons in the country to utilize the new Aeros™ Modular Stem Total Ankle System from restor3d (Raleigh, NC) during its limited market release.
