FDA OKs Tyber Medical’s NiTy+ One-Shot Staple Fixation System

Tyber Medical has earned U.S. Food and Drug Administration (FDA) 510(k) clearance for its new NiTy+ One-Shot staple fixation system.
 
According to the company, NiTy+ One-Shot is the first bone-fixation instrument of its kind with a uniquely designed, single-pass insertion instrument. It can be particularly beneficial for cases of fracture, osteotomy fixation, and joint arthrodesis.
 
“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,” Tyber Medical CEO and president Jeff Tyber told the press. “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.”
 
The insertion tool has preloaded staples and an integrated tamping mechanism so there’s no need for a second instrument to fully seat staples into the bone needing fixation. Two instruments are combined into one insertion tool, which can also reattach to the staple and boosting positioning control.
 
“The feedback we have received from surgeons involved in the cadaveric trials has been overwhelmingly positive,” said Abe Perryman, Tyber’s senior project engineer. “What they appreciate most is how our innovative insertion tool allows for streamlined bone staple implantation in orthopedic extremities surgery.”
 
NiTy+ One-Shot consists of sterile, single-use orthopedic implants and fully disposable instruments, removing the need for reprocessing. The compression staples are constructed from super-elastic nickel-titanium (Nitinol) and are available in two or four-legged designs with multiple combinations of bridge widths, leg lengths, and cross sections to accommodate various anatomies and pathologies. The staple implant applies optimum compression across bone segments when the staple implant legs are released. The disposable inserter supplies opposing forces to the staple legs to keep them parallel during implantation.