Tyber Medical said today it won FDA 510(k) clearance for its TyFix all-in-one extremity joint fixation system.
The TyFix system includes integrated implant and instrument design to minimize the number of procedure steps and improve operating room efficiency, the Bethlehem, Penn.-based company said.
“The TyFix system is the 1st device to fully integrate all instrumentation and implant into a unitary implant-instrument combination while also delivering a strong, robust construct, an efficient procedure, and minimal surgical time. The company continues to focus and enhance our distal extremity platform, is dedicated to accelerating the path to market for our private label customers and is always striving to add value through innovative solutions,” CEO Jeff Tyber said in a press release.
Tyber Medical said the kit eliminates the need for ancillary instrumentation for a “wide range of bone fixation procedures,” including hammertoe correction.
The system comes in an all-in-one sterile package to eliminate reprocessing costs, and includes the TyFix screw which combines an optimized bone thread and a barbed head to maximize bone purchase and compression in both proximal and distal phalanges, the company said.
In 2015, Tyber Medical said it licensed BioTy implant surface bacterial reduction technology from Northeastern University for use with its headless screw system.