Synergy Spine Gains Premarket Approval for Synergy Disc

Synergy Spine Solutions received 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.

Synergy is a motion-preserving artificial disc designed to treat patients with degenerative disc disease of the cervical spine. It is the first and only artificial cervical disc designed to improve anatomic alignment and to provide intentional motion preservation.

The company plans to begin U.S. commercialization of the device in 2Q26. 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.

FDA approval of the Synergy Disc is supported by clinical evidence generated through a rigorous prospective clinical study conducted under an IDE in the U.S. The company also has over 10 years of clinical experience with the Synergy Disc outside of the U.S. 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 control.

“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.”

Source: Synergy Spine Solutions