Private-label orthopaedic implant provider Tyber Medical has received clearance from Health Canada for its anatomical plating system.
The system previously received approval by the US Food and Drug Administration (FDA).
Tyber Medical CEO and president Jeff Tyber said the company secured approval for a comprehensive plating solution for long and short bone trauma and deformity.
Tyber commented: “We are excited about this development and look forward to expanding our presence in the orthopaedic plating arena.”
The anatomical plating system includes a range of stainless steel and titanium plates.
It also features both standard and variable angle locking compression plates and screws in different lengths, thicknesses, and configurations.
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Tyber said that the low-profile design of the plating system is intended to minimise soft tissue irritation.
Moreover, the system’s variable locking technology is engineered to reduce the prominence of screw heads.
The plates are available in both sterile and non-sterile options, with an emphasis on material and surface modification to significantly increase fatigue resistance.
Tyber chief commercial officer Kevin Brothen said: “This additional clearance for Canada further cements Tyber Medical as a complete global source for orthopaedic plating and we are excited for the future.”
Recently, Tyber secured 510(k) clearance from the FDA for an extension to its Mini-Frag System.
The approval introduces further screw and plate options, along with expanded indications, improving the system’s adaptability for various surgical needs.
The Mini-Frag System is designed for the fixation of fractures, osteotomies, nonunions, and fusions in small bones such as those in the hand, wrist, ankle and foot.