Medacta’s 3D Tibial Cones Cleared in U.S.

Medacta International’s 3DMetal Tibial Cones for knee revision surgery are now cleared for use in U.S. patients.

On November 3, 2017, in addition to announcing the FDA 510(k) clearance, the company also announced that Kevin Hardt, M.D., and David Manning, M.D., of the Northwestern University Feinberg School of Medicine in Chicago, Illinois and Dragan Jeremic, M.D., of St. Vincenz Krankenhaus Brakel in Brakel, Germany, performed the first surgeries using the cones.

The cones can be used for structural support, says the company, in areas of bone deficiencies that may compromise revision implant fixation, and are indicated for use with Medacta’s GMK Revision and GMK Hinge Knee systems, as well as the GMK tibial extension stems and offset.

Manning, designer of the cones, said the cones, “recreate a proximal structural foundation for the intended revision implant by achieving proximal fixation and force transmission in the remaining host bone.” Hardt said the instrumentation was straightforward to use and, “complementary to my typical revision workflow. I was impressed with the surgical press fit of the implant.”

According to the FDA clearance summary, the cones have a full-density layer that prevents cement occluding the pores of the external layer.

The cones are available in centered and eccentric versions and in sizes XS, S, M, and L with heights of 20 mm and 25 mm.

Predicate Differences

The summary states the cones are substantially equivalent to Zimmer Biomet Holdings Inc.’s Trabecular Metal Tibial Cone Augments and Regenerex Porous Titanium Sleeve Augments.

The differences between Medacta’s cones and the predicate devices, according to the summary, are that Medacta’s cones have different heights than the predicate devices. “Although the subject devices and predicate devices are made of titanium alloy, the manufacturing process method is different because the subject devices use electron beam melting to process the titanium. This technological difference does not raise new questions of safety or effectiveness and a comparison evaluation shows there are no new risks associated with the subject devices design.”

Medacta will launch its tibial cones for the U.S. market at the American Academy of Orthopaedic Surgeons Annual Meeting held in New Orleans in March 2018.