Spinal Resources Inc.’s (SRI) Bezier parametric curve spinal rod system has earned U.S. Food and Drug Administration (FDA) 510(k) clearance for compatibility with any cleared pedicle screw set available on the U.S. market, regardless of the manufacturer.

By allowing this clearance, the FDA took an important step toward acknowledging the design and compatibility of the system. It will also boost the reach and adoption of independent technologies for spine surgeons, the company said.

“From a surgeon perspective, the universal clearance for the Bezier Rod system is ground-breaking because it gives me clinical liberty to achieve the best possible outcomes with the best possible technology without being restricted to a single supplier or device manufacturer construct,” said Dr. Saman Shabani, MD, the Director of Spinal Oncology Surgery, Adult Spinal Deformity Surgery and the Spine Fellowship Program at the Medical College of Wisconsin.

Usually a spinal fixation rod is cleared for use only with pedicle screws from the same manufacturer. Hospital systems and group purchasing organizations also often restrict the number of vendors (and therefore, technology selections) available to surgeons in their facilities. Due to this, surgeon choice and patient benefit are limited to a subset of the tech available in the market.

The company said these factors limit the opportunity for the surgeon and patient communities to be made aware of the broadest possible tech options and related clinical benefits. The reality can be frustrating to surgeons who don’t want clinical decisions affected by product availability.

“We are thrilled to have achieved this universal clearance for our Bezier Rod platform,” said SRI president and CEO Bernie Bedor. SRI has taken another step towards our stated goal of addressing persistent challenges in spinal disease by developing the uniquely differentiated and biomechanically superior Bezier Rod system and successfully advocating for broad surgeon and patient access.”