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.

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