GENEVA, Aug. 11, 2026 /PRNewswire/ -- Spineart announces that the BAGUERA® C cervical disc has received FDA approval for 1 and 2 contiguous levels, expanding access in the United States to a motion-preserving solution for patients suffering from cervical disc disease.
Spineart Announces FDA Approval of BAGUERA® C Cervical Disc
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As one of Spineart's foundational technologies and a cornerstone of its cervical portfolio, BAGUERA® C brings nearly two decades of international clinical experience to a market with relatively few cervical disc replacement options. Since its introduction, over 80,000 devices have been sold worldwide, establishing a long track record of clinical use.
The FDA approval is supported by two randomized controlled trials with nearly 600 patients enrolled in the United States. Additional clinical evidence, including a 10-year follow-up study published in The European Spine Journal in 2023, demonstrated that 85% of implants maintained motion a decade after treatment, providing long-term data on preservation of motion at the treated level.
"This approval represents an important milestone for Spineart and for surgeons seeking an alternative to spinal fusion in appropriately selected patients," said Jerome Trividic, CEO of Spineart. "With nearly 20 years of international experience and proven long-term clinical outcomes, BAGUERA® C delivers robust evidence and real-world performance."
The addition of BAGUERA® C in the United States further strengthens Spineart's comprehensive portfolio of spine technologies and reinforces the company's commitment to providing surgeons with innovative solutions backed by clinical evidence, global experience, and a relentless focus on patient outcomes.
To learn more about BAGUERA® C, visit: https://www.spineart.com/us/solutions/baguera-c/
About Spineart
Spineart is a global fast-growing company in spine surgery innovation, dedicated to accelerating the adoption of cutting-edge technologies for surgeons and hospitals worldwide for the benefit of their patients. Renowned for its commitment to Quality, Innovation, and Simplicity, Spineart continues to push the boundaries of spinal surgery with its comprehensive portfolio of procedural solutions and digital technologies. Spineart was awarded the "Prix de l'Economie Genevoise 2022" for its contribution to technological and scientific innovations, commercial activities, job creations and ESG principles.
Please visit www.spineart.com and follow on LinkedIn.
Author
TH
TJ Halvorson
The De Angelis Group | Orthopedics This Week | MSK Innovations
Why This Matters
Two Perspectives
MBA Lens: Economic and industry impact
Spineart secured FDA approval for its BAGUERA® C cervical disc for 1 and 2 contiguous levels, significantly expanding its market presence in the U.S. This approval leverages nearly two decades of international experience and over 80,000 devices sold, positioning Spineart as a stronger competitor in the motion-preserving spine market. The company aims to provide an alternative to spinal fusion, reinforcing its comprehensive portfolio.
- This strategic approval enhances Spineart's competitive stance in the U.S. cervical disc replacement market, which has limited options.
- The long-standing international clinical track record supports market adoption and strengthens the company's value proposition.
PhD Lens: Clinical and outcomes impact
Spineart's BAGUERA® C cervical disc received FDA approval for 1 and 2 contiguous levels, offering a motion-preserving solution for cervical disc disease. Clinical evidence includes two randomized controlled trials with nearly 600 U.S. patients. A 10-year follow-up study demonstrated 85% of implants maintained motion, highlighting long-term functional preservation at the treated level.
- The device's efficacy is supported by robust clinical trials and a decade of follow-up data on motion preservation.
- Over 80,000 devices sold worldwide underscore its established safety and performance profile in real-world settings.
React:
Discussion
This is a fascinating development. In my practice we've seen similar outcomes with the revised protocol. The key differentiator seems to be patient selection criteria. Has anyone else noticed the correlation with BMI thresholds?
Great point. I'd push back slightly on the conclusion, the sample size in the cited study is too small to draw population-level inferences. That said, the directional signal is compelling and worth a larger RCT.
We implemented a similar approach last year. Early results are promising but we're still gathering 12-month follow-up data. Happy to share our protocol if anyone is interested.
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