Dymicron receives ISO13485 certification and CE mark for Triadyme-C

Dymicron announced recently that its Triadyme-C cervical total disc replacement device, previously the Tri-Lobe cTDR, has earned its CE mark. The company has also completed ISO13485 certification of its quality management system, according to a press release.

The achievement of these benchmarks now allows for the marketing and commercialization of the company’s next-generation Orthopedic Diamond cervical disc in the European Union countries and other countries around the world that recognize the CE mark approval process.

Dymicron’s biocompatible Orthopedic Diamond material is made of polycrystalline diamond compact, a surface meant to resist structural breakdown that can release dangerous wear debris into the body. Additionally, the proprietary tri-lobe technology features an articulation mechanism made of three spherical lobes seated within three non-congruent, spherical pockets. The motion of the three lobes within their associated pockets generates a smooth, gentle centering force that emulates the natural motion of the spine, according to the release.

Triadyme-C was recently implanted in two patients, marking the first in vivo placement of Dymicron’s unique cervical total disc replacement device, the release stated.

Reference: www.dymicron.com.