FDA clears 3D-printed implant tech to tackle aseptic loosening

Onkos Surgical, a developer of solutions for musculoskeletal oncology and complex orthopaedic procedures, has received FDA 510(k) clearance for its modular collar portfolio featuring the company's BioGrip 3D-printed implant technology.

The patented design, now available as part of the ELEOS Limb Salvage System, was created to help address the clinical challenge of aseptic loosening (also known as implant loosening) in musculoskeletal oncology and complex orthopaedic limb salvage surgery. 

With its new 3D-printed porous structure and novel Nano HA treatment, the BioGrip collar is designed to help provide bone ingrowth at the bone-implant interface which may help address aseptic loosening. The treatment helps to accelerate and enhance osseointegration.

The 3D-printed, nano HA treated design is one of two interchangeable collar designs that Onkos has added to its offering to address these complex clinical challenges. The clearance also includes an oval shaped collar design to provide greater contact in distal femoral replacements, where subsidence is a common challenge among complex revision and trauma applications.

Dr. Shervin Oskouei, division director of orthopaedic oncology at Emory University and chief of orthopaedic surgery at Emory University Hospital Midtown, said: "Research has shown that designs treated with hydroxyapatite provide greater surface area for bone ingrowth and may result in lower rates of implant loosening. 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."

Patrick Treacy, CEO and co-founder of Onkos Surgical said: "This is a historic day for Onkos Surgical. 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. Our latest innovation, the BioGrip collar portfolio, delivers on our promise to help address the challenge of implant loosening. With our focussed 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."