# PAO: Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer + Additive, Cemented

- Device class: 2; regulation: 21 CFR 888.3660; FDA's rule: 510(k) required
- FDA decisions: 1
- 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)
- 2020: 1

## Most-cited predicates
- K201315: PERFORM Humeral System – Stem (2020), cited by 6

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