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Tyber Medical’s PEEK ToeGrip Hammer Toe implant family has received Medical Device Regulation (MDR) certification from TÜV Rheinland. This marks the first time a hammer toe implant has achieved both FDA 510(k) clearance and MDR certification.
The ToeGrip family, which includes the ToeGrip Classic, ToeGrip Evo and ToeGrip Retrograde, offers versatile solutions for hammer toe deformities. The ToeGrip Retrograde, designed specifically for the U.S. market, allows for additional K-Wire fixation to enhance stability.
These implants have demonstrated success in clinical settings, having been used in over 55,000 patients with a clinical history spanning more than 14 years.
Clinical studies have consistently highlighted the effectiveness of the ToeGrip implant. A retrospective study by Harmer et al. demonstrated a high patient satisfaction rate, with 94.7% of patients reporting improvements at six months and 92.8% at three years post-operation.
“Achieving MDR certification for our ToeGrip implant family is a significant milestone for Tyber Medical,” said Jeff Tyber, CEO and President 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.”
ToeGrip implants, made from biocompatible PEEK material, offer a versatile solution for the correction of hammer toe deformities. With the addition of MDR certification, the ToeGrip family is now available to a broader market. Tyber Medical provides rapid access to FDA-cleared and CE-Marked, private label, portfolio-enhancing regulatory-approved orthopedic implants for the spinal, extremity and trauma markets.
Source: Tyber Medical LLC
