Additional screw and plate options, and indications for Mini-Frag System. Credit: PRNewsfoto/Tyber Medical.

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.

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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.

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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.