Sam Brusco, Associate Editor03.10.23
Tyber Medical, a company specializing in devices for major orthopedic trauma, extremity and spine, has received U.S. Food and Drug Administration (FDA) 510(k) clearance to expand its anatomical plate portfolio and a further clearance for MR conditional labeling.
The clearance expands the breadth of the company’s anatomical plating system with 391 additional plate configurations, including 100 targeting foot, ankle, and wrist indications.
"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," Logan Schleicher, Tyber Medical senior design engineer told the press. "The MR Conditional labeling is an important designation that brings greater value to the full portfolio of orthopedic plating devices we offer to our customers."
Tyber’s plating system is indicated to treat a range of deformity, trauma, and degenerative conditions of the wrist, foot, ankle, and long bones. The MR. conditional term means the company’s plating system can be safely used in MRI environments under certain tested conditions.
"Over the past two years, the FDA has raised the bar for the industry to meet the MR compatibility requirements," said Lisa Boyle, Tyber’s director of regulatory affairs. "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."
The company launched its anatomic plating system in 2020 when its received its initial 510(k) clearance. The latest FDA filing included new plate sizes, instrumentation, and configurations for short bones, long bones, and ankle fracture/fusion. This new submission also included ASTM testing and analysis, demonstrating the system can safely be used in the MRI environment.
The clearance expands the breadth of the company’s anatomical plating system with 391 additional plate configurations, including 100 targeting foot, ankle, and wrist indications.
"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," Logan Schleicher, Tyber Medical senior design engineer told the press. "The MR Conditional labeling is an important designation that brings greater value to the full portfolio of orthopedic plating devices we offer to our customers."
Tyber’s plating system is indicated to treat a range of deformity, trauma, and degenerative conditions of the wrist, foot, ankle, and long bones. The MR. conditional term means the company’s plating system can be safely used in MRI environments under certain tested conditions.
"Over the past two years, the FDA has raised the bar for the industry to meet the MR compatibility requirements," said Lisa Boyle, Tyber’s director of regulatory affairs. "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."
The company launched its anatomic plating system in 2020 when its received its initial 510(k) clearance. The latest FDA filing included new plate sizes, instrumentation, and configurations for short bones, long bones, and ankle fracture/fusion. This new submission also included ASTM testing and analysis, demonstrating the system can safely be used in the MRI environment.
