# K211757: Simplify Disc

- Pathway: 510(k) (Traditional)
- Applicant: Nuvasive, Inc.
- Decided: Aug 20, 2021 after 74 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: 1 generation back to P200022 (2020). 1 ancestor in all.
3 later devices descend from it; 1 cites it directly.
0 of 5 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- P200022: Simplify® Cervical Artificial Disc, Nuvasive, Inc. (2020) Summary page 5.

## Most influential descendants
- K220861: M6-C Artificial Cervical Disc Instruments AS (2022), 2 descendants of its own
- K241117: M6-C™ Single Use, Disposable Instrumentation (2024), 0 descendants of its own
- K231769: activL® Next Generation Instrumentation (2023), 0 descendants of its own

## Indications for use
The Simplify Disc Inserter FP is intended for the placement and positioning of the Simplify Cervical Artificial Disc.

Source page: https://510kreport.com/device/K211757
Methodology: https://510kreport.com/methodology