Tyber Medical Reaches a Key Certification Milestone
Tyber Medical LLC, a manufacturer known in orthopedic devices, has cleared a major hurdle. The company’s PEEK ToeGrip Hammer Toe implant family has earned Medical Device Regulation (MDR) certification. With this addition, the ToeGrip line joins a short list of options that hold both FDA 510(k) clearance and MDR certification—two demanding regulatory benchmarks that speak to safety, performance, and quality.
Hammer Toe Solutions Built for Real-World Surgery
The ToeGrip family includes three models: ToeGrip Classic, ToeGrip Evo, and ToeGrip Retrograde. Each implant is engineered to address hammer toe deformities efficiently and predictably. The ToeGrip Retrograde model is tailored for use in the U.S. and offers an option for K-Wire fixation, giving surgeons added stability during the procedure when they need it.
Clinical Use, Measured Over Time
These implants aren’t just novel on paper—they’ve been used broadly and for years. More than 55,000 patients have been treated with ToeGrip implants, supported by over 14 years of combined clinical experience. That track record reflects Tyber Medical’s focus on patient care and on meeting strict regulatory requirements through consistent, real-world performance.
Patient Satisfaction Backed by Studies
Clinical investigations continue to show strong outcomes. In a retrospective study, 94.7% of patients reported noticeable improvement at six months after surgery, and 92.8% maintained positive results at three years. The durability of those outcomes—early and sustained—matters to patients and surgeons alike.
Leadership Perspective
“Acquiring MDR certification for our ToeGrip implant family marks a pivotal moment for Tyber Medical,” stated Jeff Tyber, the CEO and President of Tyber Medical. “This accomplishment reaffirms the safety and effectiveness of our implants and showcases our steadfast commitment to meeting stringent regulatory standards. We look forward to continuing to provide high-quality, reliable solutions that enhance patient outcomes.”
Materials and Design That Support Outcomes
The ToeGrip implants are made from biocompatible PEEK, a material chosen for its versatility and compatibility in the body. That foundation supports effective correction of hammer toe deformities while maintaining options for surgical technique. With MDR certification now in place, Tyber Medical is positioned to serve a broader market, reinforcing the company’s role in orthopedic innovation.
About Tyber Medical LLC
Tyber Medical LLC supports private label programs with rapid access to regulatory-cleared implants across spinal, extremity, and trauma applications. Since 2012, the company has launched more than 50 orthopedic systems. Its work centers on innovative bioengineered technologies—including specialized surface treatments and coatings—to advance implant performance while meeting rigorous regulatory standards.
Frequently Asked Questions
What does MDR certification mean for the ToeGrip implants?
It confirms the implants meet the European Union’s Medical Device Regulation requirements for safety and performance, strengthening their credibility and opening access to EU markets.
How widely have ToeGrip implants been used?
They’ve been used in more than 55,000 patients, supported by over 14 years of cumulative clinical experience.
What material are the ToeGrip implants made from?
They’re made from biocompatible PEEK, selected for its strength, stability, and compatibility with the human body.
Which models are in the ToeGrip family?
The lineup includes ToeGrip Classic, ToeGrip Evo, and ToeGrip Retrograde. The Retrograde model also offers an option for K-Wire fixation, particularly aligned with U.S. surgical practice.
How might this certification affect Tyber Medical’s plans?
With MDR certification secured, Tyber Medical can broaden availability of the ToeGrip implants while continuing its focus on innovation and patient outcomes in the orthopedic device space.
