FDA clears Medacta’s Mpact 3D Metal hip implants

Medacta recently received FDA clearance for its Mpact 3D metal implants and Augments 3D metal to enhance its Impact system for hip revision procedures.

The new Mpact 3D Metal Acetabular Two-Hole and Multi-Hole Shells are hemispherical porous shells that feature multiple cross-linked polyethylene liner options. Its ultra-porous material makes the implants ideal for more demanding primary patient cases to fix compromised bone. Porous 3D Metal Augments complement the implants and are designed to act as a defect-filling implant in cases of severe bone loss to help increase the stability of implants.

Augments are available in a number of shapes and sizes to give surgeons the intraoperative flexibility to fix different acetabular defects.

“I was impressed with how firm the Mpact 3D Metal Implant was upon initial impaction,” said Dr. Tyler Goldberg, a surgeon who was the first to use the implant and augments in the U.S. “The shell has exceptional grip, making primary fixation easy and solid. Knowing the shell is of high porosity and solid nature gave me great confidence for durable bone ingrowth and my patient is recovering very well.”

Mpact 3D Metal Implants also feature the company’s 3D Metal technology and were made using additive manufacturing in a 3D printer. As a result, the implants had enhanced stability from a high coefficient of friction at the bone interface with a favorable environment for bone without the need for additional coating. The Augments and 3D Metal Shells have pore sizes of 600-800 micrometers and have continuously interconnected open pores with a high-porosity level of 75%.

“Medacta continues to expand upon its product portfolios as we seek to help our surgeon partners address more patient cases than ever before, whether it’s a complex primary case or a difficult revision,” said Francesco Siccardi, executive VP of Medacta. “With the new Mpact 3D Shells and 3D Metal Augments, our Mpact System offers even greater versatility and continues to instill confidence, thanks to both the high-grade materials used and the built-in surgeon education and support system for which Medacta is well known.”