Tyber Medical today said it received FDA clearance for its new line of foot and ankle plating systems.
The clearance covers more than 42 different indication-specific anatomical plating families that are developed using a combination of CT scans, cadaveric labs and consultation with surgical thought leaders.
Tyber Medical’s foot plating system is designed to treat a number of deformity, trauma and degenerative conditions to the forefoot, mid foot, rear foot and ankle. The company said it plans to launch some of its plates in the first half of 2021 and will pursue CE mark approval in Europe in the second half of next year.
“We are excited to receive the FDA clearance that officially launches Tyber Medical into the orthopedic plating arena,” president and CEO Jeff Tyber said in a news release. “Our team has developed a robust method linking intrinsic design and ease of use for a variety of surgical indications. We expect to expand this methodology beyond the lower extremities and into all areas of the skeletal anatomy.”
The plating systems feature a 30º, multi-angle, locking mechanism that is designed for superior stability between the plate and screws. The modular, tray delivery system is also customizable with a color-coded, clean layout that helps meet surgeons’s instrumentation needs. It also features a 1.3 mm low profile plates to minimize soft tissue irritation and maximize the variable locking technology to reduce screw head prominence.
“Our system is designed to minimize soft tissue trauma during the procedure,” senior engineer Melissa Coale said. “Our plates feature geometry to reduce overall prominence, especially in areas with minimal soft tissue coverage.”
Tyber Medical’s ankle plating system is designed for fore-, mid-, hind foot, ankle repair and ankle fusion. They are indicated for use in the fixation of phalanges, metatarsals and small bone fragments in the forefoot and medium-to-large bones and multi-fragments in the mid- and hindfoot.