Tyber Medical today said it received FDA 510(k) clearance for its expanded line of anatomical plating system.
The Bethlehem, Pennsylvania-based Tyber Medical added mini-frag/small bone, long bone fracture and ankle fracture/fusion plates to its offering following the FDA clearance. The company designed the system to address the stabilization of fractures, osteotomies, joint fusions, non-unions and fusions of small bones and small bone fragments to the hand, wrist, foot and ankle.
“Tyber Medical now offers a comprehensive plating solution that bridges different indications and proliferates throughout the entire body to address trauma and deformity to the long and short bones,” director of research and development Melissa Coale said in a news release.
Tyber Medical’s long bone fracture plates have a straight, low-contact locking plate and a 1/3 locking tubular plate. It incorporates hybrid cortical/cancellous threat with both variable angle locking and standard non-locking screws.
“Our second and largest FDA Clearance makes Tyber Medical a complete source for orthopedic plating for our partners and the surgeons they serve,” said CEO Jeff Tyber. “It’s been less than 12 months from our first FDA clearance, underscoring the speed at which we can utilize our clinical research to develop, test, and iterate to fill the gaps in our partners’ product portfolios with innovative solutions that benefit patient outcomes.”
The company plans to launch its new fixation systems in 2022 while it seeks CE mark approval.