Onkos Surgical today announced that it received FDA 510(k) clearance for its BioGrip 3D-printed implant technology.
The Parsippany, N.J.–based company designed BioGrip to address the clinical challenge of aseptic loosening in musculoskeletal oncology and complex orthopedic limb salvage surgery. It helps provide bone ingrowth at the bone-implant interface.
The 3D-printed porous structure, nano HA treated design is one of two interchangeable collar designs, according to the company. The FDA clearance also includes an oval-shaped collar design for greater contact in distal femoral replacements where subsidence is a common challenge.
“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,” CEO Patrick Treacy said in a news release. “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 orthopedic procedures.”
BioGrip available as a part of the Onko Surgical’s Eleos limb salvage system.