# NKG: Posterior Cervical Screw System

- Device class: 2; regulation: 21 CFR 888.3075; FDA's rule: 510(k) required
- FDA decisions: 119
- 510(k) review time 2021–2025: median 58 days (middle half 55–108)
- Recalls: 4 (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)
- 2017: 15
- 2018: 12
- 2019: 8
- 2020: 14
- 2021: 7
- 2022: 7
- 2023: 10
- 2024: 3
- 2025: 6
- 2026: 4

## Most-cited predicates
- K142838: Synapse Occipital-Cervical-Thoracic (OCT) System (2015), cited by 32
- K143471: VERTEX Reconstruction System (2015), cited by 19
- K151885: SUMMIT SI OCT Spinal Fixation System, MOUNTAINEER OCT Spinal System (2015), cited by 11
- K153631: Zimmer Virage OCT Spinal Fixation System (2016), cited by 10
- K163375: INFINITY™ OCT System (2017), cited by 7
- K161591: QUARTEX™ Occipito-Cervico-Thoracic Spinal System, Globus Navigation Instruments (2016), cited by 6
- K190895: MOUNTAINEER OCT Spinal System, SUMMIT SI OCT Spinal Fixation System, SYMPHONY OCT System, SUMMIT Fixation System (2019), cited by 5
- K152338: VERTEX (r) Reconstruction System (2015), cited by 5
- K151755: OASYS (r) System (2015), cited by 5
- K150552: ELLIPSE and PROTEX CT OCCIPITO-CERVICO-THORACIC SPINAL SYSTEMS (2015), cited by 5

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