FDA approved the Synergy Disc on February 26 under P250028. Synergy Spine Solutions of Louisville, Colorado filed the PMA on July 31, 2025, so the original approval took 210 days. The label covers single-level cervical disc replacement at C3 to C7 after discectomy. Patients must have radiculopathy or myelopathy and six failed weeks of conservative care. Product code MJO.
The disc pairs titanium alloy endplates with a polyethylene core that carries a built-in 6-degree lordotic angle. The angle is meant to correct segmental alignment as well as keep motion. In the IDE trial against ACDF, composite clinical success was 87.1%, superior to fusion with p<0.0001. At 24 months, 91.7% of disc patients improved on the Neck Disability Index versus 75.2% for fusion, and 84.5% were satisfied versus 61.6%. Disc angle moved from 2.6 degrees before surgery to 6.5 degrees.
The device has sold outside the US for more than 10 years in more than 10 countries; the first patient was implanted in 2009. Founder Neil Duggal is chief medical officer and Josh Butters, a former Stryker engineer, is CEO. Amzak Health led a $30 million Series A in January 2024 to finish the trials. A 200-patient two-level IDE is fully enrolled, with two-year data due later in 2026. US sales begin this spring.
A 210-day original PMA is about as fast as Class III gets. A decade of OUS use and a superiority result on the primary endpoint make for a short deficiency list.