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Tyber Medical receives 510(k) clearance for opening osteotomy wedge systems

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Tyber Medical LLC has received 510(k) clearance from the FDA for its TyWedge Opening Osteotomy Wedge Systems.

“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,” Chris Faresich, TyWedge team leader, stated in a company press release.

Featuring radiolucent properties of PEEK with a titanium plasma spray coating, the TyWedge system allows for angular corrections in the foot with an optimized tooth profile for initial stability, according to the release. Optimized for bone graft containment, the TyWedge has radiographic markers for intraoperative visualization and simple instrumentation for precise implant placement.

The TyWedge comes in two configurations with a total of 15 footprints, which includes the Evans TyWedge with nine foot prints and the Cotton TyWedge, which will launch with six footprints.

Reference: www.tybermedical.com