Tyber Medical has secured 510(k) clearance from the US Food and Drug Administration (FDA) for an extension to its Mini-Frag System.
The approval introduces additional screw and plate options, along with expanded indications, enhancing the system’s adaptability for various surgical needs.
The line extension includes 1.3mm screws and plates, broadening the Mini-Frag System’s applicability.
Tyber Medical worldwide strategic partnerships senior director Eric Dickson said: “The clearance for the additional plates and screws offers surgeons the ability to treat a larger population, specific to smaller anatomy.”
Tyber said the FDA clearance marks a significant expansion of its healing capabilities and adds to the company’s comprehensive restorative portfolio.
The Mini-Frag System is designed for the fixation of fractures, osteotomies, nonunions, and fusions in small bones such as those in the hand, wrist, ankle and foot.
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Available in both titanium and stainless steel, the Anatomical Plating System aims to provide surgeons with a versatile, precise and efficient solution for bone repair and healing.
Tyber Medical founder and CEO Jeff Tyber said: “We expect this product to drive significant growth for our customers.”
Last year, Tyber Medical secured approval from the FDA and European Union Medical Device Regulation (EU MDR) for its implantable K-Wires and Steinmann Pins.
Both the wires and pins are produced using 316L stainless steel and the titanium alloy Ti6AL4V ELI.
The K-Wires and Steinmann Pins are offered in several configurations, including combinations of trocar tip, diamond tip, fluted tip, partial thread, full thread, ball end and flat end.