Tyber Medical has secured approval from the US Food and Drug Administration (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.
Available in sterile and non-sterile options, the approved 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.
These wires and pins offer comprehensive solutions for healthcare professionals, with lengths ranging from 60mm to 450mm and diameters between 0.6mm and 6.35mm.
Tyber Medical CEO Jeff Tyber said: “Our focus has always been on developing products that are innovative, efficient and deliver unparalleled performance.
“Receiving the FDA and MDR clearance for these platforms is a testament to our rigorous pursuit of advancing patient care while helping our customers expand their brand.”
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Tyber Medical also secured a reusable indication for its K-Wires in Europe following its recent acquisition of ADSM-Synchro Medical.
Commenting on the European expansion, ADSM SAS (Tyber Medical France) president Luigi Bivi said: “This development is a key component of our strategic initiative to provide advanced medical solutions worldwide.
“Tyber Medical’s sterile-packed reusable platform in Europe enhances our capabilities and allows us to better serve high-quality standards while maintaining a cost-effective approach to our product offering.”
In May this year, Tyber Medical announced the expansion of its facility in Florida, US, by an additional 33,000ft².
The expansion included the addition of new manufacturing machines, secondary equipment and a range of advanced technologies.