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Synergy Spine Solutions Earns FDA Approval for the Synergy Disc, Advancing Cervical Disc Replacement in the U.S.

Milestone approval advances a new category of artificial cervical disc technology uniquely engineered to preserve motion and improve spinal alignment

Synergy Spine Solutions®, a medical device company focused on improving the quality of life for patients undergoing spine surgery, today announced it has received U.S. Food and Drug Administration (FDA) Premarket Approval (PMA) for the Synergy Disc® for 1-level indications at C3-C7. The Synergy Disc achieved superiority to the fusion control on the primary endpoint of composite clinical success.

The Synergy Disc is a unique motion-preserving artificial cervical disc designed to treat patients with degenerative disc disease (DDD) of the cervical spine. It is the first and only artificial cervical disc designed to improve anatomic alignment and to provide intentional motion preservation, using time-tested and trusted materials. FDA approval of the Synergy Disc is supported by clinical evidence generated through a rigorous prospective clinical study conducted under an Investigational Device Exemption (IDE) in the U.S. The company also has over 10 years of clinical experience with the Synergy Disc outside the United States in more than 10 countries, where the device has been commercially available and implanted in thousands of patients.

The IDE study results demonstrated that the Synergy Disc achieved superiority in composite clinical success compared to the anterior cervical discectomy and fusion (ACDF) control, with the following results at 24 months:

  • The Synergy Disc primary endpoint of composite clinical success was 87.1%, achieving superiority (p<0.0001) to the fusion control.
  • 91.7% of patients in the Synergy Disc group achieved a clinically meaningful improvement on the Neck Disability Index at 2 years, compared to 75.2% in the fusion group.
  • The mean Neck pain score of 15.6 (0-100 VAS) in the Synergy Disc group was lower than 30.2 in the fusion group.
  • Synergy Disc patients had lower worst arm pain scores (15.0) than the fusion group (32.2).
  • Disc angle in the Synergy Disc group increased from 2.6 pre-operatively to 6.5 degrees at 24 months.
  • Overall patient satisfaction was higher in the Synergy Disc group at 84.5% compared to 61.6% in the fusion group.

“FDA approval of the Synergy Disc marks a pivotal moment– bringing U.S. surgeons and patients the first motion-preserving disc that also corrects focal spinal alignment with its unique lordotic core,” said Josh Butters, CEO of Synergy Spine Solutions. “We are thrilled with the clinical outcomes achieved in this study and this approval reflects years of focused development, clinical evaluation, and surgeon-led innovation aimed at solving persistent challenges in cervical disc replacement.”

The Synergy Disc is intended for use at one cervical level (C3 through C7) following removal of a degenerated cervical disc and addresses both motion preservation and spinal alignment in a single device. Built with input from practicing surgeons and using trusted orthopedic materials, the Synergy Disc is intended to support consistent surgical outcomes and reliable postoperative imaging. The device reflects Synergy Spine Solutions’ approach to innovation, combining clinical insight with features developed to meet real-world procedural and patient needs.

“Cervical disc degeneration affects a significant and growing patient population in the U.S., and the demand continues to accelerate for motion-preserving surgical options,” said Neil Duggal, MD, Chief Medical Officer of Synergy Spine Solutions. “Bringing the Synergy Disc to the U.S. market provides surgeons with access to a unique technology that preserves motion while addressing segmental alignment. This will significantly increase the addressable patient population and represents an important evolution in cervical disc replacement technology.”

Synergy Spine Solutions plans to begin commercialization of the Synergy Disc in the United States in Spring 2026. The Synergy Disc is also being evaluated in a separate IDE study in the U.S. for 2-level indications. The 2-level trial is fully enrolled, and two-year follow-up will be completed later this year. The Synergy Disc is limited to investigational use for 2-level indications.