The Bezier Parametric Curve Rod System from Spinal Resources (SRI) received FDA 510(k) clearance for compatibility with any cleared pedicle screw set available on the U.S. market, regardless of manufacturer.
By allowing this first-of-its-kind universal clearance, FDA acknowledges the sophistication of the design and compatibility of SRI’s system.
Typically, a spinal fixation rod is cleared for use with pedicle screws from the same manufacturer. In addition, hospital systems and group purchasing organizations often restrict the number of vendors available to surgeons in their facilities. The result is that surgeon choice and patient benefit are limited to a subset of the technologies available in the overall market.
This may limit the opportunity for surgeon and patient communities to be made aware of the broadest possible technology options and associated clinical benefits. This reality poses frustration to surgeons who do not want their clinical decisions impacted by product availability.
Bernie Bedor, President and Chief Executive Officer, notes, “We are thrilled to have achieved this universal clearance for our Bezier Rod platform. 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.”
The Bezier Parametric Curve Rod System from Spinal Resources (SRI) received FDA 510(k) clearance for compatibility with any cleared pedicle screw set available on the U.S. market, regardless of manufacturer.
By allowing this first-of-its-kind universal clearance, FDA acknowledges the sophistication of the design and compatibility of SRI's...
The Bezier Parametric Curve Rod System from Spinal Resources (SRI) received FDA 510(k) clearance for compatibility with any cleared pedicle screw set available on the U.S. market, regardless of manufacturer.
By allowing this first-of-its-kind universal clearance, FDA acknowledges the sophistication of the design and compatibility of SRI’s system.
Typically, a spinal fixation rod is cleared for use with pedicle screws from the same manufacturer. In addition, hospital systems and group purchasing organizations often restrict the number of vendors available to surgeons in their facilities. The result is that surgeon choice and patient benefit are limited to a subset of the technologies available in the overall market.
This may limit the opportunity for surgeon and patient communities to be made aware of the broadest possible technology options and associated clinical benefits. This reality poses frustration to surgeons who do not want their clinical decisions impacted by product availability.
Bernie Bedor, President and Chief Executive Officer, notes, “We are thrilled to have achieved this universal clearance for our Bezier Rod platform. 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.”
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