# PEK: Spinous Process Plate

- Device class: 2; regulation: 21 CFR 888.3050; FDA's rule: 510(k) required
- FDA decisions: 49
- 510(k) review time 2021–2025: median 64 days (middle half 56–93)
- Recalls: 1 (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: 4
- 2017: 3
- 2018: 4
- 2020: 2
- 2021: 2
- 2022: 3
- 2023: 4
- 2024: 1
- 2025: 1
- 2026: 1

## Most-cited predicates
- K131238: Affix Spinous Process Plate System (2013), cited by 6
- K130438: Axle Interspinous Fusion System (2013), cited by 6
- K140046: Spinous Process Fusion (SPF) Plate (2015), cited by 4
- K151741: HA Minuteman G3 MIS Fusion Plate (2015), cited by 4
- K133091: Zip Mis Interspinous Fusion System (2013), cited by 4
- K163428: HA Minuteman G3-R MIS Fusion Plate (2017), cited by 3
- K132411: Affix II Spinous Process Plate System (2013), cited by 3
- K133052: Affix (R) Next Gen Spinous Process Plate System (2013), cited by 3
- K213266: Inspan ScrewLES Fusion System (2021), cited by 3
- K153302: coflex-IF (2016), cited by 2

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