Onkos Surgical, a provider of orthopaedic oncology medical devices, has received 510(k) clearance from the Food and Drug Administration (FDA) for its portfolio of modular 3D printed BioGrip collars.
Available as part of the company’s ELEOS Limb Salvage System, the porous medical devices are designed to support bone growth in bone cancer survivors and other complex limb salvage cases. The patented designs work by improving contact between bone implants and the patient’s body, alleviating the risk of aseptic loosening (aka implant loosening) and enhancing the post-op healing process.
Patrick Treacy, CEO and co-founder of Onkos Surgical, said, “This is a historic day for us. When we started the company, we set out to deliver innovation that would directly address the long-established clinical challenges of limb salvage surgery – soft-tissue attachment, implant loosening, and infection. In the past six months, we have made significant progress by launching new ELEOS products aimed at improving the challenges of soft tissue attachment.”
Challenges in orthopaedic oncology
The American Cancer Society estimates that 3,610 new cases of bone and joint cancer will be diagnosed in 2021, with about 2,060 deaths to boot. As well as chemotherapy and radiotherapy, one of the main treatments for bone cancer is the surgical removal of the cancerous section. Luckily for some, it’s often possible to reconstruct or replace the bone that’s been removed via the use of a bone implant, which tends to be made of titanium.
Ultimately, the main aim of a bone implant surgery is for the implant to outlast the patient. Therefore, to ensure long term success, a stable initial implant fixation is absolutely crucial. According to Onkos Surgical, aseptic loosening failures are one of the leading causes of limb salvage prosthesis failure, and can be a major detriment to the overall healing process. The company’s 3D printed BioGrip collars are built to address exactly this.
Treacy adds, “Our latest innovation, the BioGrip collar portfolio, delivers on our promise to help address the challenge of implant loosening. With our focused commercial approach and substantial R&D investments, we will continue to be the leading provider of innovative solutions for musculoskeletal oncology and other complex orthopaedic procedures.”
The 3D printed BioGrip collars
Onkos Surgical’s BioGrip collars feature a 3D printed porous structure and have undergone a novel nano hydroxyapatite treatment. This combination reportedly helps accelerate the process of osseointegration, whereby the patient’s bone connects with the implant and starts to grow around it.
The 3D printed collar is one of two interchangeable collar designs recently launched by Onkos Surgical. The new FDA clearance also covers the company’s oval-shaped collar design, which is suitable for use in distal femoral replacement procedures.
“Research has shown that designs treated with hydroxyapatite provide greater surface area for bone ingrowth and may result in lower rates of implant loosening,” concludes Dr. Shervin Oskouei, Chief of Orthopedic Surgery at Emory University Hospital Midtown. “Having this technology available at the bone-implant junction is critical to supporting a reconstruction that may lead to improved implant longevity for these complex procedures.”
This certainly isn’t the first time the FDA has approved medical devices and other products created via 3D printing technology. Just last month, Desktop Health, the recently launched health business of 3D printer manufacturer Desktop Metal, received 510(k) clearance for its proprietary Flexcera Base resin. The material is optimized for the 3D printing of dental prosthetics.
Elsewhere, Chinese pharmaceutical firm Triastek recently received Investigational New Drug (IND) approval from the FDA for its first 3D printed drug product. Named T19, the 3D printed tablet is designed to treat rheumatoid arthritis, an autoimmune disease that makes joints stiff and swollen.
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Featured image shows products in the ELEOS Limb Salvage System. Photo via Onkos Surgical.
