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Tyber Medical obtains FDA 510(k) for TyWedge Opening Osteotomy Wedge systems

Medical device firm Tyber Medical has received 510(k) approval from the US Food and Drug Administration (FDA) for its TyWedge Opening Osteotomy Wedge systems.

TyPEEK, a proprietary titanium plasma sprayed PEEK implant specifically indicated for fusion, can now be used for the TyWedge Opening Osteotomy Foot system.

TyWedge team leader Chris Faresich said: "This FDA clearance is an important milestone for Tyber Medical where a superior wedge design allows for fusion with the use of allograft or autograft for an optimal flat foot opening osteotomy correction."

The TyWedge system features the radiolucent properties of PEEK with a titanium plasma spray coating and an optimized tooth profile for initial stability, allowing the system to use for angular corrections in the foot.

The system is available in two configurations with a total of 15 footprints, including the Evans TyWedge with nine foot prints and the Cotton TyWedge that will be launched with six foot prints.

Tyber Medical produces around 26,000 different product configurations across 15 different product lines.