3D Systems and Smith+Nephew Get 510(k) Clearance for 3D Printed Ankle Replacement Treatment

3D Systems (NYSE: DDD) has received 510(k) clearance for its TOTAL ANKLE Patient-Matched Guides. The guide system will be used in conjunction with Smith+Nephew’s SALTO TALARIS Total Ankle Prosthesis and CADENCE Total Ankle System. The solution integrates pre-surgical planning with patient-specific custom surgical instrument tools, enabling more accurate total ankle replacement surgery. This treatment is often used for osteoarthritis in the ankle, which has a global incidence of around 1 to 3 per 100,000 people, most likely in wealthier nations.

The system is designed to improve surgical accuracy and reduce errors by minimizing the number of steps involved. Correct alignment of the guides on the bone is crucial for the success of the procedure, as the guides must be precise for the patient to walk properly. Additionally, the company hopes to reduce the procedure’s duration, which benefits both doctors and hospital bottom lines. This software tooling is built onto 3D Systems’ Virtual Surgical Planning (VSP) suite, which also addresses craniomaxillofacial (CMF) and extremities. 3D Systems aims to use this as a stepping stone to develop more procedure-specific software solutions and to drive its implant printing business.

“With over 25 years of experience, our solutions have supported more than 175,000 patient-matched cases with the goal of improving surgical outcomes and the overall patient experience. Our VSP surgical planning workflow including the expertise of our biomedical engineers, our Selective Laser Sintering technology, and our DuraForm ProX PA materials is a differentiator in the market and was instrumental in the success of this program within a short timeframe,” stated Ben Johnson, 3D Systems’ Vice President of Portfolio & Regulatory.

“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. This advanced system is designed to offer unparalleled efficiency and accuracy, ultimately enhancing the overall experience for both surgeons and patients,” said Smith+Nephew´s Vice President of Marketing of Global Orthopaedic, Mark McMahan.

“Over the last several years, we have continued to leverage our VSP surgical planning workflows to expand into other personalized total joint orthopedic applications like shoulders and ankles. 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. This is yet another great example of how our personalized orthopedics business continues to grow,” said 3D Systems General Manager and Senior Vice President, Medical Devices, Gautam Gupta.

3D Systems states that it has produced over 2 million devices, and the business appears promising moving forward. The firm aims to expand into trauma and orthopedics, where it is likely to encounter Materialise, a long-time leader in the field. Indeed, 3D Systems’ strategy positions it as a direct competitor to Materialise in personalized surgical guides, both in CMF and beyond. In the realm of surgical planning software, the company is already a direct competitor.

The customized surgical guide space is a lucrative one that is poised for expansion. Over a million customized surgical guides have been produced for dental and medical applications across the body. Generally, workflows are faster and more accurate, reducing the likelihood of errors. By improving the precision of holes, incisions, and placements, patient outcomes are enhanced. Instruments, trays, and plugs can all be customized, making procedures less prone to mistakes. While it is a straightforward application, it requires significant regulatory work and consistent excellence to succeed. This also makes it a trust-based business with a substantial moat. If someone could offer a cheaper solution, skepticism would likely precede interest. Across CMF, orthopedics, extremities, oncology, and trauma, there are numerous procedures that could benefit from improved guides. As more countries become wealthier, they will be able to undertake more of these procedures. At the same time, more accurate and streamlined surgical planning allows doctors to be more efficient, increasing revenue while reducing errors. This is a promising business for 3D Systems, and it will be interesting to observe their growth in this sector in the coming years.