Spinal Elements’ cervical fixation system wins FDA nod

Spine surgery technology developer Spinal Elements announced today that it received FDA clearance for its Sapphire X product for anterior cervical fixation.
Sapphire X is comprised of integrated instrumentation and high-angulation screws designed to help surgeons perform a procedure while preserving the patient’s skeletal and muscle tissue. The instrumentation is designed to reduce procedural steps and complexity, while the low-overhang implant is designed to minimize disruption to the nearby healthy anatomy once the procedure has taken place, according to a news release.
The system joins Spinal Elements’ MIS Ultra platform, which the company launched last month to move beyond small incisions and consider the implications of spine surgery after the procedure has taken place, including reducing the disruption of the healthy anatomy surrounding the area of interest. Spinal Elements intends to begin the commercial introduction of the Sapphire X system in the coming months.
“We are thrilled that Sapphire X, another organically developed MIS Ultra solution, is one step closer to clinical use and commercial introduction,” Spinal Elements president & CEO Jason Blain said in the release. “We believe Sapphire X has the potential to improve the intra-operative experience while reducing long-term adjacent level degeneration, one of the recognized unintended consequences in this application.”

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