The prodisc® L Lumbar Total Disc Replacement (TDR) system has received certification under the European Union Medical Device Regulation (MDR), meeting rigorous European standards for quality, safety, and performance.
Backed by more than 35 years of clinical experience with prodisc technology, prodisc L offers a proven motion-preserving treatment option for appropriately selected patients with degenerative disc disease.
The prodisc L certification follows the September 2025 MDR certification of the prodisc C Vivo and prodisc C Nova Cervical Total Disc Replacement Systems, marking another important regulatory milestone for Centinel Spine and its global TDR portfolio.
Centinel Spine® Receives MDR Certification for prodisc® L Lumbar Total Disc Replacement System
Centinel Spineprodisc C Vivototal disc replacementcertificationprodisc C NovacervicalEUMDR
WEST CHESTER, Pa., Nov. 12, 2026 /PRNewswire/ -- Centinel Spine®, LLC ("the Company"), a commercial-stage medical technology company focused exclusively on total disc replacement (TDR) and advancing motion-preserving solutions for the cervical and lumbar spine, today announced that its prodisc L Lumbar TDR system has received certification under the European Union Medical Device Regulation (MDR).
prodisc L
This achievement demonstrates compliance with rigorous European regulatory standards for medical device quality, safety, and performance—supporting the continued availability of prodisc L throughout the European market.
Speaking about the importance of continued access to motion-preserving TDR technologies, Orthopedic Spine Surgeon Dr. Caroline Hirsch of the CCV Montpellier in Castelnau-le-Lez, France stated, "Patients are no longer satisfied with fusion when other options may be available. They are increasingly well informed and rightfully seek motion-preserving alternatives. Thanks to Centinel Spine's relentless work, we are able to provide this type of care to patients in France and across Europe. In my opinion, as a spine surgeon, both lumbar and cervical total disc replacement have become an established and essential part of spinal care."
Centinel Spine CEO Steve Murray added, "Achieving MDR certification for prodisc L is an important milestone that reflects our longstanding commitment to globally delivering clinically-proven technologies. This accomplishment builds on the legacy of prodisc and our dedication to advancing total disc replacement solutions for patients worldwide."
The prodisc L certification follows the Company's September 2025 announcement of MDR certification for its prodisc C Vivo and prodisc C Nova cervical total disc replacement systems. Together, these certifications support Centinel Spine's continued cervical and lumbar TDR leadership in the European markets.
The prodisc L Lumbar TDR system has been in clinical use internationally since 1990 and is designed to preserve motion at the treated spinal level while providing an alternative to fusion for appropriately selected patients with degenerative disc disease. The device incorporates prodisc CORE technology, featuring a fixed core design intended to provide controlled motion and is the basis behind the predictable clinical outcomes of every prodisc device after over 35 years and 300,000 implantations worldwide.
With decades of clinical use and extensive long-term published evidence, prodisc L reflects Centinel Spine's longstanding history of delivering clinically proven total disc replacement technologies to surgeons and patients worldwide.
About Centinel Spine, LLC
Centinel Spine®, LLC is a commercial-stage medical technology company with a singular mission to transform spine surgery by advancing motion-preserving solutions for the cervical and lumbar spine. The Company is exclusively focused on total disc replacement (TDR), which the Company believes represents a fundamentally different and increasingly important approach to spine surgery compared to traditional fusion techniques that permanently eliminate motion. Centinel Spine's prodisc platform is designed to improve the long-term quality of life for patients suffering from chronic neck and back pain while preserving the spine's natural movement. The Company believes that its depth of technology, exclusive focus, and long history of clinical success uniquely position it to lead the continued evolution of spine surgery toward motion-preserving solutions.
For more information, please visit the company's website at www.CentinelSpine.com or contact:
Varun Gandhi
Chief Financial Officer
900 Airport Road, Suite 3B
West Chester, PA 19380
Phone: 484-887-8871
Email: v.gandhi@centinelspine.com
SOURCE Centinel Spine, LLC
Author
TH
TJ Halvorson
The De Angelis Group | Orthopedics This Week | MSK Innovations
Why This Matters
Two Perspectives
MBA Lens: Economic and industry impact
Centinel Spine secured EU MDR certification for its prodisc L Lumbar TDR system, ensuring continued market access and strengthening its competitive position in Europe. This follows prior cervical TDR certifications, solidifying the company's strategic focus on motion-preserving solutions and global leadership in the total disc replacement market. This regulatory achievement supports Centinel Spine's portfolio expansion and market penetration.
- The MDR certification ensures Centinel Spine's continued market access and compliance in the rigorous European medical device landscape.
- This milestone reinforces the company's exclusive TDR strategy and strengthens its leadership in both cervical and lumbar European markets.
PhD Lens: Clinical and outcomes impact
The prodisc L Lumbar TDR system achieved EU MDR certification, validating its quality, safety, and performance. Leveraging over 35 years of prodisc technology and 300,000 implantations, it offers a motion-preserving alternative to fusion for degenerative disc disease. Its fixed core design, prodisc CORE technology, provides controlled motion, supported by extensive long-term clinical evidence for predictable outcomes.
- The prodisc L system utilizes a fixed core design (prodisc CORE technology) to provide controlled motion, preserving spinal movement.
- Clinical evidence spans over 35 years and 300,000 implantations, demonstrating predictable outcomes and safety for degenerative disc disease.
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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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