The prodisc® C Vivo and prodisc® C SK are now indicated for reconstruction of a C3 to C7 vertebral disc after discectomy at one or two contiguous levels. A landmark IDE clinical study successfully demonstrated the safety and clinical efficacy of prodisc C Vivo and prodisc C SK, achieving the highest overall two-level composite clinical success rate compared to any other approved cervical total disc replacement (TDR) device.1 The prodisc C Vivo and prodisc C SK Match-the-Disc™ system has now become the first and only cervical TDR system with two Different devices approved for one and two level use. Centinel Spine’s prodisc technology is now the only TDR solution in the US approved for single- and two-level use in both the cervical and lumbar spine.
WEST CHESTER, Pa., Oct. 14, 2025 /PRNewswire/ — Centinel Spine®, LLC (“the Company”), the leading global medical device company focused exclusively on the treatment of cervical and lumbar spine diseases with the world’s most comprehensive and clinically proven total disc replacement (TDR) technology platform (prodisc®), today announced pre-approval Marketing (PMA) from the US Food and Drug Administration (FDA) for 2 levels. Indications for prodiscC Vivo and prodisc C SK Cervical TDR devices. Since receiving FDA approval for 1-level indications in July 2022, more than 1,100 surgeons in the U.S. have implanted nearly 20,000 prodiscC Vivo and prodisc C SK spinal levels.
“It’s an exceptional day for cervical arthroplasty!” commented Armen Khachatryan MD, orthopedic spine surgeon at the Disc Replacement Center in Salt Lake City, UT. “I am delighted to witness the culmination of our efforts in the prodiscC Vivo and prodiscCSK clinical trial for bi-level indications, which resulted in FDA approval. I am particularly excited about the integration of the various endplate configurations of the prodisc devices into my clinical practice. This approval expands the range of treatment options available to patients and underscores the continued evolution and refinement of surgical methods that preserve movement. techniques for cervical spine disorders,” Dr. Khachatryan concluded.
A total of 480 subjects were enrolled in the IDE clinical study at 31 centers, and the PMA is based on the analysis of 433 subjects, which is the largest number of subjects used to support a PMA for any cervical TDR device on the market. The clinical study was the first of its kind to evaluate two investigational TDR devices and the first PMA-based IDE clinical study comparing an investigational system to a PMA-approved cervical TDR device.
According to Dr. Jad Khalil, orthopedic spine surgeon at Michigan Orthopedic Surgeons, Southfield, MI, “Cervical disc arthroplasty is an excellent alternative to traditional fusion surgery. Multiple clinical trials have shown excellent results, and our research group was fortunate to be part of this innovative clinical trial on the next generation of devices.” prodisc cervical for 2-level arthroplasty. The difference between the prodiscC Vivo and prodiscC SK systems is the ability to adapt the implant to the patient’s anatomy for a more personalized approach to the procedure. “We are excited to see the launch of expanded indications for this system.”
For study patients who reached the 24-month endpoint, results from the IDE clinical study demonstrated:
Patients treated with prodisc C Vivo and prodisc C SK had statistically noninferior (i.e., equivalent) outcomes compared to patients treated with the control cervical TDR device.2 Patients treated with prodisc C Vivo and prodisc C SK achieved an overall composite clinical success rate of 87.1% (vs. 83.7% for control cervical TDR),2 which is the clinical success rate Higher overall composite by two levels compared to any other approved cervical TDR. TDR cervical device.1 93.9% of prodisc C Vivo and prodisc C SK patients achieved a significant improvement (15 points) in the neck disability index (NDI) versus 90.1% for the control cervical TDR.2 96.9% of prodisc C Vivo and prodisc C SK patients had no secondary surgical interventions (revision, removal, reoperation, supplemental fixation) at index vs. 95.7% for control cervical TDR.2
Centinel Spine CEO Steve Murray summarized: “This is a historic milestone for Centinel Spine and further advances treatment options for spine surgeons and their patients. The IDE trial supporting this FDA approval is a landmark study that uses another FDA-approved disc device as a control and includes two different investigational devices that could be used for the same patient. This 2-tier approval advances “The concept of uniquely matching the disc to each level of the patient’s cervical spine is a huge step forward in total disc replacement.”
The prodisc C Vivo has been used clinically internationally since 2009 and is currently one of the most frequently implanted TDR devices in the world. The device offers keelless insertion and combines a unique anatomically designed top endplate with side tips to optimize fit and provide immediate fixation. The prodisc C SK device features a flat end plate designed for optimized implant positioning that allows surgeons to address the patient’s individual anatomy, with a low-profile central keel that offers immediate fixation and allows for an optimized keel preparation technique. Both devices incorporate prodisc CORE technology, the basis behind the predictable clinical results of each prodisc device after more than 35 years and 275,000 implants worldwide.3
1 The reported study success rate is based on the overall success rate of the primary analysis population in the SSED for each cervical total disc replacement device with two-level indications.
2 For detailed information about the IDE study, see the Summary of Safety and Efficacy Data at 2level.centinelspine.com.
3 Data archived in Centinel Spine
About Centinel Spine, LLC
Centinel Spine®, LLC is the world’s leading medical device company focused exclusively on addressing cervical and lumbar spine diseases with prodisc®, the world’s most comprehensive total disc replacement (TDR) technology platform.
The company’s prodisc technology is the most studied and clinically tested TDR system in the world, validated by more than 540 published articles and more than 275,000 implants. Centinel Spine’s prodisc is the only TDR technology with multiple motion-preserving anatomical solutions, allowing the surgeon to Match-the-Disc™ with each patient’s anatomy for cervical and lumbar total disc replacement.
For more information, please visit the company’s website at www.CentinelSpine.com or contact:
Varun Gandhi
CFO
900 Airport Road, Suite 3B
West Chester, Pennsylvania 19380
Phone: 484-887-8871
Email: v.gandhi@centinelspine.com
SOURCE Centinel Spine, LLC
