Armis Biopharma Gains FDA Clearance for VeriFixx Small Bone Implant

By Julie A. Vetalice

Armis Biopharma Gains FDA Clearance for VeriFixx Small Bone Implant

Armis Biopharma received FDA 510(k) clearance to market the VeriFixx™ Small Bone Implant for fixation of osteotomies and reconstruction of the lesser toes following correction procedures for hammertoe, claw toe and mallet toe.

VeriFixx is designed to support shorter time to ambulation, shorter overall recovery time and reduced pain.

VeriFixx employs an alignment fin design and a sub-micron layer of titanium molecularly bonded to a PEEK implant using atomic fusion deposition. It is designed to provide ideal fixation alignment and a bone-friendly surface, while retaining PEEK's biocompatibility,  modulus of elasticity similar to bone and radiographic visibility.

"For patients requiring a small bone implant, the length of recovery and pain are common concerns," said Ted Ziemann, Chairman and CEO of Armis Biopharma. "With our unique proprietary design, we are excited to bring a new technology to the medical device market that specifically addresses these concerns while maintaining the benefits of current standard of care."

Product Labels: Lower Extremity

Tags: 510(k) Clearance, Regulatory