Tyber Medical said Wednesday it won FDA 510(k) clearance for its TyWedge osteotomy wedge system.
The TyWedge is a titanium plasma sprayed PEEK indicated for fusion in osteotomy operations, and allows for angular corrections in the foot, according to the Morristown, N.J.-based company.
“The TyWedge system marries the radiolucency of PEEK-Optima with the osseointegration properties of titanium allowing for direct visualization of the healing process,” Dr. Selene Parekh of Duke University said in prepared remarks.
The TyWedge system features radiolucent properties and an optimized tooth profile for initial stability, the company said. The device comes in 2 configurations with a total of 15 footprints.
“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,” Tywedge team lead Chris Faresich said in a press release.
In July, Tyber Medical acquired an exclusive licensing agreement for Northeastern’s BioTy antimicrobial surface coating technology designed for orthopedic applications. The agreement includes refining the manufacturing process as well as supplying funding for ongoing scientific studies, the company said.
