FDA Grants 510(k) Clearance to Tyber for Osteotomy Wedge Systems

The FDA has granted 510(k) clearance to Tyber Medical, LLC for its TyWedge Opening Osteotomy Wedge Systems, a titanium plasma sprayed PEEK wedge implant.

The TyWedge system is featured with TyPEEK titanium plasma sprayed PEEK coating specifically indicated for fusion and initial stability through an optimized tooth profile with a high friction surface, which allows for angular corrections in the foot.

Selene G. Parekh, an associate professor in the Department of Orthopedic Surgery at Duke University, says the system allows for “direct visualization of the healing process.”

The Morristown, N.J.-based Tyber Medical develops implants and instruments for orthopedic companies. — Michael Cipriano