# JOF: Polymer, Ent Synthetic, Porous Polyethylene

- Device class: 2; regulation: 21 CFR 874.3620; FDA's rule: 510(k) required
- FDA decisions: 6
- 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)
- 1977: 2
- 2000: 1
- 2009: 1
- 2017: 1
- 2020: 1

## Most-cited predicates
- K083621: Medpor Customized Surgical Implant (2009), cited by 5
- K171037: PoreStar Patient Specific Implant (2017), cited by 1

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