Synergy Spine Solutions, Inc. · Class II · Cleared Mar 27, 2026
| K-number | K253392 |
| Device name | Synergy Disc Instruments |
| Applicant | Synergy Spine Solutions, Inc. |
| Product code | QLQ |
| Device class | Class II |
| Decision date | Mar 27, 2026 |
| Decision | Substantially Equivalent |
| Regulation | 888.4515 |
The Synergy Disc Instruments are a collection of reusable surgical instruments designed for placement, positioning, and removal of the Synergy Disc during total disc replacement surgery. The instruments are made from various stainless steel grades and medical-grade polymers including HDPE and PPSU.
The Synergy Disc Instruments share the same intended use, indications for use, and incorporate similar materials as the predicate devices. They have identical sterilization processes and conditions of use as the Centinel Spine prodisc C SK, prodisc C Nova, and prodisc C Vivo instruments.
ASTM A564, ASTM A276, ASTM A666, ASTM F899, and ASTM D6712 are cited as standards describing the materials used. Bench testing included retainer and pin verification, pin and driver verification, pilot cutter testing, modular depth stop testing, life and durability testing, and usability/cadaver testing.
The Synergy Disc Instruments are substantially equivalent to the predicate devices because they share the same intended use, indications for use, similar materials, identical sterilization process, and identical conditions of use. Non-clinical testing demonstrated the instruments perform as intended and are substantially equivalent to the predicates.
View the full FDA submission: accessdata.fda.gov