Onkos’ new 3D printed biological fixture obtains FDA approval

The modular 3D printed BioGrip collar combination of Onkos Surgical, a supplier of orthopedic oncology medical devices, has obtained 510(k) approval from the U.S. Food and Drug Administration (FDA). As part of the company’s ELEOS limb salvage system, these porous medical devices are designed to support bone growth in bone cancer survivors and other complex limb salvage cases. These patented designs work by improving the contact between the bone implant and the patient’s body, reducing the risk of aseptic loosening (also known as implant loosening), and enhancing the postoperative healing process.

Patrick Treacy, CEO and co-founder of Onkos Surgical, said: “This is a historic day for us. When we started the company, our goal was to provide innovation that directly addresses the long-standing clinical practice of limb salvage surgery. Challenges-soft tissue attachment, implant loosening and infection. In the past six months, we have made significant progress and launched a new ELEOS product aimed at improving the challenges of soft tissue attachment.”

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The American Cancer Society estimates that 3,610 new cases of bone and joint cancer will be diagnosed in 2021, and about 2,060 people will die. In addition to chemotherapy and radiotherapy, one of the main treatments for bone cancer is to remove the cancerous part through surgery. Fortunately, for some people, it is usually possible to rebuild or replace the removed bone by using bone implants, which are often made of titanium. In the final analysis, the main purpose of bone implant surgery is to extend the life of the implant to the patient. Therefore, to ensure long-term success, a stable initial implant fixation is absolutely critical. According to Onkos Surgical, aseptic loosening failure is one of the main reasons for the failure of limb salvage prosthesis, and may cause significant damage to the entire healing process. The company’s 3D printed BioGrip collar is designed to solve this problem. Treacy added: “Our latest innovative product, the BioGrip collar combination, fulfills our commitment to help solve the challenge of implant loosening. With our focused business approach and substantial R&D investment, we will continue to be a musculoskeletal tumor. A leading supplier of innovative solutions for medical and other complex orthopedic surgery. “Onkos Surgical’s BioGrip collar has a 3D printed porous structure and has been treated with a new type of nano-hydroxyapatite. According to reports, this combination helps accelerate the process of osseointegration, where the patient’s bones connect with the implant and begin to grow around it.

The 3D printed collar is one of two interchangeable collar designs recently launched by Onkos Surgical. The new US Food and Drug Administration license also includes the company’s oval collar design, which is suitable for distal femoral replacement surgery. “Research shows that the design with hydroxyapatite treatment provides a larger surface area for bone growth and may result in a lower rate of implant loosening,” concluded Dr. Shervin Oskouei, director of orthopedics at Emory University Midtown Hospital. “Having this technology at the bone-implant junction is essential to support reconstruction, which may increase the implant lifespan of these complex surgeries.” This is certainly not the first time that the US Food and Drug Administration has approved medical devices and other products manufactured through 3D Printing technology. Just last month, 3D printer manufacturer Desktop Metal’s recently launched health business, Desktop Health, received a 510(k) license for its proprietary Flexcera Base resin. The material is optimized for 3D printing dental restorations.

Elsewhere, Triastek, a Chinese pharmaceutical company, recently obtained New Drug Research (IND) approval from the FDA for its first 3D printed drug product. The 3D printed pill, called T19, is designed to treat rheumatoid arthritis, an autoimmune disease that makes joints stiff and swollen. 

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