# PQC: Pedicle Screw Placement Guide

- Device class: 2; regulation: 21 CFR 888.3070; FDA's rule: 510(k) required
- FDA decisions: 8
- 510(k) review time 2021–2025: median 85 days (middle half 72–98)
- 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)
- 2016: 1
- 2018: 3
- 2020: 1
- 2021: 1
- 2023: 1
- 2026: 1

## Most-cited predicates
- K173472: MySpine Pedicle Screw Placement Guides – MC and Drill Pilot Instruments (2018), cited by 4
- K203673: MySpine Pedicle Screw Placement Guides Extension (MySpine Low Profile Guides, MySpine MC and Drill Pilot Guides, and MySpine S2-Alar/Alar Iliac Guides) (2021), cited by 3
- K200792: MySpine S2-Alar/Alar-Iliac Pedicle Screw Placement Guides (2020), cited by 3
- K162419: FIREFLY® Pedicle Screw Navigation Guide (2016), cited by 2
- K181399: FIREFLY® Pedicle Screw Navigation Guide (2018), cited by 2
- K181883: FIREFLY® Midline Navigation Guide (2018), cited by 1

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