Tyber Medical receives FDA clearance for single-step staple fixation system
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Tyber Medical has announced FDA 510(k) clearance of the company’s NiTy+ One-Shot staple fixation system for use in patients undergoing fracture, osteotomy fixation and joint arthrodesis surgery, according to a press release.
The NiTy+ One-Shot system uses a single insertion tool with pre-loaded compression staples made of super-elastic nickel-titanium and a tamping mechanism, which eliminates the need for secondary instrumentation. The staples are available in two- or four-legged designs in various bridge widths, leg lengths and cross sections to accommodate a variety of anatomies and pathologies, according to the release.
“We are pleased to receive another FDA clearance that extends our reach into the orthopedic device market with our ever-growing suite of cleared bone-fixation devices,” Jeff Tyber, CEO and president of Tyber Medical, said in the release. “Our product design and engineering team developed a superior method for staple implantation that enhances surgical efficiency. With one instrument, surgeons can deploy and insert staples, while remaining focused on the field of view at all times,” Tyber said in the release.
“The feedback we have received from surgeons involved in the cadaveric trials has been overwhelmingly positive,” Abe Perryman, senior project engineer at Tyber Medical, said in the release. “What they appreciate most is how our innovative insertion tool allows for streamlined bone staple implantation in orthopedic extremities surgery,” he said.
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