RōG Sports Medicine Gets FDA Nod for PEEK Suture Anchor

RōG Sports Medicine Inc., based in Orland Park, Ill., 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.

The three suture anchors made from 6-mm diameter Zeniva PEEK rod stock are implants that aid in re-attaching soft tissue to bone. The 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. The anchors 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 offers advantages compared to metals such as titanium for these implantable devices, according to RōG. Benefits include biocompatibility, chemical inertness, and a modulus of elasticity that is close to that of bone. It also has 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.

“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.
        
RōG’s sales and distribution will be handled by OrthoDirectUSA, based in Fort Wayne, Ind.

“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 the implants will be 60-80 percent 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.

“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.”