# EZX: Mesh, Surgical, Metal

- Device class: 2; regulation: 21 CFR 878.3300; FDA's rule: 510(k) required
- FDA decisions: 12
- 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)
- 1989: 2
- 1990: 1
- 1995: 1
- 1998: 1
- 2002: 1
- 2003: 5
- 2009: 1

## Most-cited predicates
- K900138: Motech Titanium Surgical Mesh (1990), cited by 5
- K023882: The Hedrocel Trabecular Metal Reconstruction System (2003), cited by 3
- K024169: Macropore OS Reconstruction (2003), cited by 3
- K014200: Optimesh (2003), cited by 3
- K032344: The Hedrocel Trabecular Metal Reconstruction System Model 10-330 (2003), cited by 2
- K983766: Synthes Synmesh (1998), cited by 1
- K032282: Modification to Hedrocel Trabecular Metal Reconstruction System (2003), cited by 1

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