RōG Sports Medicine Inc., an environmentally-focused start-up company which produces affordable, high-quality implants, has received 510(k) clearance from the U.S. Food & Drug Administration (FDA) for its new RōG Suture Anchor made of Zeniva polyetheretherketone (PEEK) resin from Solvay Advanced Polymers, LLC, a Solvay Specialty Polymers company.Zeniva PEEK – part of Solvay’s line of Solviva Biomaterials – has a modulus very close to that of bone plus excellent toughness and fatigue resistance. The FDA clearance was based in part on Solvay’s well-developed master access file for Zeniva PEEK.
The three suture anchors made from 6-mm diameter Zeniva PEEK rod stock are implants that aid in re-attaching soft tissue to bone. These implants are threaded so they screw into bone, thus securing the soft tissue to the prepared bone surface so that the soft tissue and bone re-unite.
These high-quality RōG suture anchors provide the surgeon with high strength and functional performance. They come in a range of sizes and variable diameters to maximize a surgeon’s options to accommodate a patient’s natural anatomy. The implants are widely used in many parts of the body where soft tissue and bone have been separated, resulting in pain and loss of motion.
“Zeniva PEEK provides not only the exceptional properties that are required of high-precision implants, but has lowered the barrier for a small company like ours to afford this high-tech material and help to lower the high price of health care,” said Dr. Blair Rhode, president & CEO of RōG Sports Medicine. Dr. Rhode is also an owner of an out-patient surgery center and is determined to eliminate waste and change the way implants are distributed today.
RōG is solely focused on manufacturing high-quality implants and its sales and distribution will be handled by OrthoDirectUSA. “The cost of healthcare in the U.S. is not sustainable in its present form and the value stream needs to be re-defined,” said Tommy Mitchell, president of OrthoDirectUSA. “The true cost of the implant is a small part of the selling cost and it is our mission to teach, train, and coach hospitals and surgery centers to take back this responsibility and reap the associated savings.”
The cost of these implants will be 60% to 80% less than what facilities pay today for virtually the same implants, according to Mitchell. The direct access model eliminates the significant sales and marketing expense of the traditional orthopedic supply company today, he added.
Zeniva PEEK offers numerous advantages over metals such as titanium for these implantable devices. The material offers many important benefits including biocompatibility, chemical inertness, and a modulus of elasticity that is close to that of bone. It boasts high strength and stiffness and is totally radiolucent enabling the surgeon to clearly see the bone/soft tissue interface on x-rays without the shadows and opacity of titanium.
“We’re excited about the commercial adoption of Zeniva PEEK for these very popular implants,” said Judy Melville, global business development manager for Solviva Biomaterials. “With an aging population and more active lifestyles, there is a growing demand for these procedures.” The company has made significant investments and performed all applicable required testing to ensure that Zeniva PEEK meets or exceeds the critical regulatory and performance standards set by the FDA for this application.
Zeniva PEEK and the entire line of Solviva Biomaterials are manufactured in compliance with the relevant aspects of ISO 13485 and under the relevant aspects of current Good Manufacturing Practices. Solvay’s biomaterial manufacturing processes are carefully validated and enhanced controls provide product traceability. In addition, all materials are tested in an accredited lab that is ISO 17025 compliant. Solvay is currently in active product trials with several medical device manufacturers using Zeniva PEEK as well as other Solviva biomaterials.
In addition to Zeniva PEEK, the Solviva Biomaterials line includes Proniva self-reinforced polyphenylene (SRP), one of the world’s stiffest and strongest unreinforced thermoplastics that offer exceptional hardness and biocompatibility; Veriva polyphenylsulfone (PPSU), which provides unsurpassed toughness combined with transparency and excellent biocompatibility; and Eviva polysulfone (PSU), which offers practical toughness in a strong, transparent polymer.
