Among First Hammer Toe Implants to Achieve Both FDA 510(k) and MDR Clearance
Newswise — BETHLEHEM, Pa., Sept. 10, 2024 /PRNewswire/ -- Tyber Medical LLC, a leading orthopedic device manufacturer specializing in private label implants for the extremity, trauma, and spine markets, is proud to announce that its PEEK ToeGrip Hammer Toe implant family has received Medical Device Regulation (MDR) certification from TÜV Rheinland. This prestigious certification marks the first time a hammer toe implant has achieved both FDA 510(k) clearance and MDR certification, setting a new standard for orthopedic implants.
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. The proven clinical experience and efficacy of the ToeGrip implants underscore Tyber Medical's commitment to advancing patient care and delivering innovative solutions that meet the highest regulatory standards.
Clinical studies have consistently highlighted the effectiveness of the ToeGrip implant¹²³. 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-operation².
"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."
The ToeGrip implants, made from biocompatible PEEK material, offer our customers a versatile and effective solution for the correction of hammer toe deformities. With the addition of MDR certification, the ToeGrip family is now available to a broader market, further solidifying Tyber Medical's position as a leader in orthopedic innovation.
About Tyber Medical LLC
Tyber Medical LLC is a leading orthopedic device manufacturer providing rapid access to FDA-cleared and CE-marked, private label, portfolio-enhancing regulatory-approved orthopedic implants for the spinal, extremity, and trauma markets. Since its founding in 2012, the company has released more than 50 spine, extremity, and trauma systems. Tyber Medical aims to develop and utilize differentiated bioengineered technologies, including surface treatments and coatings, to create advanced orthopedic implants.
References:
- Averous, C., Leider, F., Rocher, H., et al. (2015). Interphalangeal Arthrodesis of the Toe With a New Radiolucent Intramedullary Implant. Foot & Ankle Specialist, 12(5), 458-464. doi:10.1177/1938640015599031.
- Harmer, J. L., Wilkinson, A., & Maher, A. J. (2017). A Midterm Review of Lesser Toe Arthrodesis With an Intramedullary Implant. Foot & Ankle Specialist, 10(5), 458-464. doi:10.1177/1938640017704943.
- Hendrick, S. E., & Kannegieter, E. (2020). SmartToe, ToeGrip and buried k-wire versus percutaneous k-wire fixation for 2nd PIPJ arthrodesis: A comprehensive review of outcomes. The Foot, 45, 101692. doi:10.1016/j.foot.2020.101692.
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