FDA Clears GMReis’ Braided Surgical Sutures

GMReis has earned its second U.S. Food and Drug Administration (FDA) 510(k) clearance in less than a week, gaining its latest authorization for its STITCH Surgical Sutures.

The second FDA clearance follows last week’s sanction of its VersaLock Sterile Plating System (Aug. 20).

A key differentiator behind the latest FDA authorization is GMReis’ in-house braiding capability, company executives claim. GMReis controls the development and manufacturing of its high-strength braided sutures within its own production facility, a specialized capability held by a relatively limited number of orthopedic device manufacturers.

The STITCH portfolio includes non-absorbable, high-strength surgical sutures ranging from USP 4-0 through USP 5, as well as braided sleeves engineered for integration with suture anchors and flexible fixation systems.

GMReis’ braiding facility and manufacturing process were validated to produce these braided components within a controlled cleanroom environment without requiring a conventional post-braiding washing process. Eliminating this manufacturing step reduces the use of chemical mixtures, detergents and other processing agents typically associated with conventional washing processes while simplifying the manufacturing flow.

By bringing braiding technology in-house, GMReis gains direct control over critical product characteristics including fiber selection, diameter, braid architecture, mechanical performance and product configuration. This capability also provides greater flexibility to develop proprietary braided structures specifically engineered for different orthopedic applications.

The FDA clearance therefore represents more than the addition of another product family to GMReis’ U.S. portfolio, according to the company. It validates an important internal manufacturing technology platform that can support the development of sutures and braided sleeves for the company’s next generation of suture anchors, flexible fixation systems and soft-tissue repair technologies, GMReis management said.

“Vertical integration of braiding technology gives GMReis greater control over product development, manufacturing and innovation,” the company stated. “We can engineer the braided component together with the implant rather than treating the suture as a separate component, creating new opportunities for integrated orthopedic fixation solutions.”

The clearance further strengthens GMReis’ technology platform for sports medicine, foot and ankle, hand and wrist, trauma and soft-tissue fixation, while supporting the company’s continued expansion in the U.S. orthopedic market.

GMReis is a Brazilian company that develops, manufactures, and commercializes implants and surgical instruments for orthopedic and spine surgery.