Corentec Gains FDA Clearance for Hip Implants with DMT Coating

By Julie A. Vetalice

Corentec Gains FDA Clearance for Hip Implants with DMT Coating

Corentec obtained FDA 510(k) clearance to market the BENCOX Mirabo Z Cup Cortinium, an artificial hip cup.

Corentec's artificial hip joint is reported to be the world's first to be applied with Directed Energy Deposition (DED) biometallic 3D-printed coating technology, and is a product that replaces the nasal part of the hip joint damaged by indications such as degenerative lesions, fractures, rheumatoid arthritis and tumors.

DMT coating technology irradiates the surface of an artificial joint with a laser and melts medical titanium powder to create a porous structure similar to a bone.

Further details on the technology:

  • The coating is completely fused to the surface of the artificial cup to maintain firm fixation after surgery
  • Company claims it is the world's only second-grade pure titanium (Grade II) application
  • Forms pores of approximately 200 to 500 μm size to provide the optimal pore size for the best production of human bones
  • Exhibitis strong initial fixing power immediately after surgery by forming about three times the surface roughness compared to titanium plasma coating

Corentec expects to increase supply in earnest by securing global technology competitiveness with this FDA clearance of artificial hip joint cups, and will supply products to the U.S. market in the near future.

Further, Corentec is developing an ankle joint replacement and an artificial knee joint made of cobalt-chrome alloy using DMT coating technology, and plans to complete and release the products in 2023 and 2024, respectively.

"BENCOX Mirabo Z Cup Cortinium, which was created after more than 10 years of development, is a next-generation product that replaces existing titanium plasma coating products and changes the paradigm of coating technology," said Michael Sun, CEO of Corentec.

Source: Corentec

Product Labels: Hip Replacement

Tags: 510(k) Clearance, Regulatory