# QLQ: Manual Instruments Designed For Use With Total Disc Replacement Devices

- Device class: 2; regulation: 21 CFR 888.4515; FDA's rule: 510(k) required
- FDA decisions: 10
- 510(k) review time 2021–2025: median 59 days (middle half 58–72)
- Recalls: 0 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026; MAUDE to Sep 30, 2026

## Decisions per year (last 10)
- 2021: 1
- 2022: 2
- 2023: 1
- 2024: 2
- 2025: 1
- 2026: 3

## Most-cited predicates
- K221848: prodisc C SK, prodisc C Nova, and prodisc C Vivo Instruments (2022), cited by 3
- K220861: M6-C Artificial Cervical Disc Instruments AS (2022), cited by 2
- K242869: prodisc® L Instruments (2024), cited by 1
- K211757: Simplify Disc (2021), cited by 1

Source page: https://510kreport.com/product-code/QLQ
Data by year (CSV): https://510kreport.com/product-code/QLQ.csv