www.fdanews.com/articles/210204-tyber-medicals-nity-one-shot-staple-bone-fixation-system-cleared
Tyber Medical’s NiTy+ One-Shot Staple Bone Fixation System Cleared
November 17, 2022
The FDA has granted 510(k) clearance to Tyber Medical for its NiTy+ One-Shot staple fixation system, that combines pre-loaded staples with a tamping mechanism, eliminating the need for a second instrument to fully seat staples into the bone.
The sterile system, which includes single-use orthopedic implants and disposable instruments, is especially useful in cases of fracture, osteotomy fixation and joint arthrodesis, the company said.
The staples are constructed from super-elastic nickel-titanium and are available in multiple combinations of bridge widths, leg lengths, and cross sections.
The insertion tool can also reattach to the inserted staple to adjust its positioning.