Tyber Medical’s Innovative PEEK ToeGrip Implants Win Certification
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Tyber Medical Celebrates Major Certification Milestone
Tyber Medical LLC, a distinguished manufacturer in the orthopedic device industry, has recently reached a significant achievement. The company proudly announces that its PEEK ToeGrip Hammer Toe implant family has obtained Medical Device Regulation (MDR) certification. This remarkable achievement establishes Tyber Medical's implants as one of the few in the market to have secured both FDA 510(k) clearance and MDR certification.
Innovative Hammer Toe Solutions
The ToeGrip family comprises several models, including the ToeGrip Classic, ToeGrip Evo, and ToeGrip Retrograde. These aligners are thoughtfully designed to address hammer toe deformities effectively. Notably, the ToeGrip Retrograde version has been specifically crafted for the U.S. audience, featuring an option for K-Wire fixation to provide enhanced stability during procedures.
Clinical Success and Proven Efficacy
The ToeGrip implants are not just innovative; they have also shown impressive results in clinical practice. Over 55,000 patients have benefitted from these implants, with a collective clinical experience exceeding 14 years. The data gathered underscores Tyber Medical's unwavering commitment to fostering superior patient care through cutting-edge solutions that adhere to rigorous regulatory mandates.
Patient Satisfaction and Clinical Studies
Clinical investigations consistently reveal the effectiveness of the ToeGrip implants. A retrospective study highlighted a remarkable satisfaction rate, demonstrating that 94.7% of patients experienced noticeable improvements at six months post-operation, and 92.8% maintained positive outcomes at the three-year mark.
Leadership Insights
“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.”
Material Innovations in Orthopedic Technology
The ToeGrip implants are constructed from biocompatible PEEK material, which provides versatility and allows for effective correction of hammer toe deformities. With the addition of MDR certification, these implants are positioned to reach a more extensive market, solidifying Tyber Medical's reputation as a pioneer in orthopedic innovation.
About Tyber Medical LLC
Tyber Medical LLC stands at the forefront of orthopedic device manufacturing, offering rapid access to regulatory-approved implants that enhance private label portfolios within the spinal, extremity, and trauma sectors. Since its inception in 2012, the company has introduced over 50 distinct orthopedic systems. The mission of Tyber Medical revolves around the development and utilization of innovative bioengineered technologies, which includes specialized surface treatments and coatings to create advanced orthopedic implants.
Frequently Asked Questions
What is the significance of the MDR certification for Tyber Medical's implants?
The MDR certification signifies that the ToeGrip implants meet the highest safety and effectiveness regulations within the European market, enhancing their credibility and market reach.
How many patients have used the ToeGrip implants?
Over 55,000 patients have utilized the ToeGrip implants, showcasing their widespread acceptance and effectiveness in clinical settings.
What material are the ToeGrip implants made from?
The ToeGrip implants are made from biocompatible PEEK material, which is well recognized for its strength and compatibility with the human body.
What types of ToeGrip implants are available?
The ToeGrip family includes the ToeGrip Classic, ToeGrip Evo, and ToeGrip Retrograde, each designed to cater to different aspects of hammer toe deformities.
What does the future hold for Tyber Medical?
With the recent MDR certification, Tyber Medical aims to expand the availability of its ToeGrip implants, continuing its mission to innovate and lead in the orthopedic device market.
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