# K253392: Synergy Disc Instruments

- Pathway: 510(k) (Traditional)
- Applicant: Synergy Spine Solutions, Inc.
- Decided: Mar 27, 2026 after 178 days
- Product code: QLQ (Manual Instruments Designed For Use With Total Disc Replacement Devices)
- Device class: 2
- Regulation: 21 CFR 888.4515
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 2 generations back to P070001 (2007). 2 ancestors in all.
No later device cites it as a predicate yet.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K221848: prodisc C SK, prodisc C Nova, and prodisc C Vivo Instruments, Centinel Spine, LLC (2022) Summary page 5.

## Indications for use
The Synergy Disc Instruments are intended for the placement, positioning, and removal of the Synergy Disc.

Source page: https://510kreport.com/device/K253392
Methodology: https://510kreport.com/methodology