Tyber Medical’s Hammertoe Implant Family Earns MDR Cert

Tyber Medical has received Medical Device Regulation (MDR) certification from TÜV Rheinland for its PEEK (polyether ether ketone) ToeGrip hammertoe implant family.
 
This certification, according to the company, is the first time a hammertoe implant has earned both U.S. Food and Drug Administration (FDA) 510(k) clearance and MDR certification.
 
The ToeGrip family includes ToeGrip Classic, TeoGrip Evo, and TeoGrip Retrograde. The latter was designed for the U.S. market and allows for additional K-Wire fixation for enhanced stability.
 
Tyber Medical boasts that these implants have been used in more than 55,000 patients in a clinical history totaling over 14 years. A retrospective study of the ToeGrip implant showed that 94.7% of patients reported improvements at six months, and 92.8% at three years after operation.
 
“Achieving MDR certification for our ToeGrip implant family is a significant milestone for Tyber Medical,” said Jeff Tyber, president and CEO of Tyber Medical. “This certification not only validates the safety and effectiveness of our implants but also reflects our dedication to complying with the most stringent regulatory requirements. We are excited to continue providing our customers with high-quality, reliable solutions that improve patient outcomes.”
 
In February of this year, Tyber obtained FDA clearance for its Proximal Tibia Plating System for complete and partial articular fractures.