Louisville, Colorado-based Synergy Spine designed the Synergy Disc as a unique, motion-preserving, artificial disc system. It treats patients with degenerative disc disease (DDD) of the cervical spine.
The company said in a news release that the Synergy Disc is the first and only artificial disc designed to improve alignment and provide intentional motion preservation, using time-tested and trusted materials. Synergy Spine supported FDA approval through clinical evidence from a study conducted under FDA investigational device exemption (IDE). It also touts 10 years of clinical experience outside the U.S. in more than 10 countries.
Synergy Spine’s IDE study saw the Synergy Disc achieve superiority in composite clinical success compared to the anterior cervical discectomy and fusion (ACDF) control at 24 months.
The disc’s indication covers use at one cervical level (C3 through C7) after removal of a degenerated cervical disc. It addresses both motion preservation and spinal alignment in a single device. Synergy Spine said its disc aims to support consistent surgical outcomes and reliable post-operative imaging.
“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 cervical disc currently leading the market is the Highridge Mobi-C (formerly from ZimVie/Zimmer Biomet).
