Medacta International SA, based in Castel San Pietro, Switzerland, has begun its commercial use of 3DMetal Femoral Cones for revision knee arthroplasty after receiving 510(k) clearance from the U.S. Food and Drug Administration (FDA) and CE marking.
The company describes its 3DMetal as an advanced biomaterial that employs a 3D printing technology. “Built upon the clinical success of 3DMetal Tibial Cones, the Femoral Cones can be used for structural support in areas of bone deficiencies that may compromise revision implant fixation and are indicated for use with Medacta’s GMK [Global Medacta Knee] Revision and GMK Hinge Knee systems.”
David W. Manning, M.D., vice chair of the Department of Orthopaedic Surgery at the Feinberg School of Medicine at Northwestern University in Chicago, Illinois, designer of the 3DMetal Femoral Cones said: “The 3DMetal Femoral Cones from Medacta are extremely versatile, utilize the clinically proven 3DMetal technology and are very user friendly for surgeons looking to restore metaphyseal and metadiaphyseal structures from which to build a revision TKA construct. The addition of these cones to the Medacta revision portfolio allows me to efficiently and reliably tackle the most difficult femoral revision scenarios.”
According to the company, “The 3DMetal Femoral Cones are characterized by a triple layer structure, patented by Medacta, with a middle full-density layer to avoid cement protrusion through the outer layer pores and increases the mechanical properties of the implant. The innovative interconnecting pore structure of these implants, similar to that of native cancellous bone, enables direct mechanical and functional connection with the bone.”
Dr. Manning described one of the key product features to OTW, “The high surface roughness of these cones, combined with central and eccentric shapes, facilitates excellent initial stability and long-term boney in-growth potential for cavitary, segmental and combined defects.”
