TyPEEK, a proprietary titanium plasma-sprayed PEEK implant specifically indicated for fusion, now is available for the Tyber Medical TyWedge Opening Osteotomy Foot system. The TyWedge system features the radiolucent properties of PEEK with a titanium plasma spray coating, as well as an optimized tooth profile for initial stability, allowing for a versatile system for angular corrections in the foot, the company noted in a news release. The TyWedge System also is optimized for bone graft (autograft or allograft) containment, 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: The Evans TyWedge with nine foot prints and the Cotton TyWedge which will launch with six foot prints.
"The TyWedge system marries the radiolucency of PEEK-Optima with the osseointegration properties of titanium allowing for direct visualization of the healing process," said Selene G. Parekh, M.D., associate professor with the Department of Orthopedic Surgery at Duke University in Durham, N.C.
The TyWedge system adds another titanium plasma sprayed PEEK system to Tyber Medical's portfolio of CE-Marked and FDA-approved private labeled implants. Tyber Medical's portfolio now includes more than 26,000 different product configurations across 15 different product lines, including the titanium plasma sprayed Evans and Cotton Wedge system.
"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," said Chris Faresich, TyWedge team leader.
Based in Morristown, N.J., Tyber Medical designs and develops Class II orthopedic systems. TyWedge is the latest addition to a product portfolio in spine and orthopedics that includes headless compression trauma screws, an anterior cervical plating system, and a full line of spinal interbody spacers.
designs and develops Class II orthopedic systems. Its BioTy technology is the latest addition to a product portfolio in spine and orthopedics that includes headless compression trauma screws, an anterior cervical plating system, and a full line of spinal interbody spacers.