Medacta wins FDA nod for 3DMetal knee revision implants

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Medacta said today it won FDA clearance for its 3DMetal tibial cones designed for knee revision surgery.

The first procedures with the device were recently performed by Dr. Kevin Hardt and device designer Dr. David Manning of Chicago’s Northwestern University Feinberg School of Medicine and Dr. Dragan Jeremic of Brakel, Germany’s St. Vincenz Krankenhaus, the Switzerland-based compay said..

“Medacta’s 3DMetal Tibial Cones recreate a proximal structural foundation for the intended revision implant by achieving proximal fixation and force transmission in the remaining host bone,” Dr. Manning said in a prepared statement.

“The instrumentation was straightforward to use and complementary to my typical revision workflow. I was impressed with the surgical press fit of the implant,” Dr. Hardt said in a press release.

“I am very satisfied with this new implant and the result. From now on, this will be an excellent option for my patients,” Dr. Jeremic said in prepared remarks.

The newly cleared 3DMetal tibial cones are designed to be used as structural support in areas of bone deficiencies which could compromise revision implant fixation and are cleared for use with the company’s GMK revision and GMK hinge knee systems and GMK tibial extension stems and offsets.

“It is Medacta’s mission to be a partner for our surgeons, even in the most challenging scenarios. With our innovative 3DMetal technology, we have extended the range of advanced solutions for our surgeons and we will continue to do so in the future,” Medacta EVP Francesco Siccardi said in a press release.

Last month, Medacta said it won FDA clearance for its Anatomic shoulder and reverse shoulder components designed as part of its Medacta shoulder system.

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