Tyber Medical has secured the US Food and Drug Administration (FDA)’s 510(k) clearance for expanding its anatomical plate portfolio along with an additional clearance for MR Conditional labelling.
The orthopedic device manufacturer said that the latest clearance from the regulator extends its Anatomical Plating System’s breath with 391 more plate configurations. These include 100 new plates that target indications in the foot, ankle, and wrist.
Tyber Medical senior design engineer Logan Schleicher said: “Our latest 510(k) clearance, including the MR Conditional designation from the FDA, expands the scope and impact of our product portfolio, giving our customers rapid access to a greater breadth of regulatory-cleared, innovative orthopedic devices that enhance patient care.
“The MR Conditional labelling is an important designation that brings greater value to the full portfolio of orthopedic plating devices we offer to our customers.”
The company’s 510(k) cleared plating system is authorised to be used for the treatment of a variety of deformity, degenerative, and trauma, conditions of the foot, ankle, wrist, and long bones.
According to Tyber Medical, the MR Conditional term lets the company’s Anatomical Plating System to be used safely in the MRI environment under some tested conditions.
The Anatomical Plating System was launched officially by the orthopedic device manufacturer in 2020 after the product line was granted its initial 510(k) clearance from the FDA.
The latest FDA filing included new plate sizes, instrumentation and configurations for long bones, short bones, and ankle fracture/fusion.
Tyber Medical’s new submission also covered ASTM testing and analysis, which showed that the system can be safely employed in the MRI environment.
Tyber Medical regulatory affairs director Lisa Boyle said: “Over the past two years, the FDA has raised the bar for the industry to meet the MR compatibility requirements.
“Our vertically integrated team has gone above and beyond to meet these requirements, and is very excited that our Anatomical Plating System has demonstrated safety in the MR environment, permitting us to label our system as MR Conditional.”
