# PHX: Shoulder Prosthesis, Reverse Configuration

- Device class: 2; regulation: 21 CFR 888.3660; FDA's rule: 510(k) required
- FDA decisions: 207
- 510(k) review time 2021–2025: median 153 days (middle half 59–205)
- Recalls: 35 (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: 11
- 2018: 14
- 2019: 9
- 2020: 13
- 2021: 21
- 2022: 9
- 2023: 9
- 2024: 9
- 2025: 9
- 2026: 18

## Most-cited predicates
- K041066: Encore Reverse Shoulder Prosthesis (2005), cited by 25
- K080642: Comprehensive Reverse Shoulder (2008), cited by 24
- K161742: Aequalis PerFORM Reversed, Aequalis PerFORM+ Reversed Glenoid (2016), cited by 21
- K051075: Encore Reverse Shoulder Prosthesis (2005), cited by 19
- K021478: Delta Shoulder (2003), cited by 19
- K030941: Aequalis Reversed Shoulder Prosthesis (2004), cited by 17
- K062250: Delta Xtend Reverse Shoulder System (2007), cited by 17
- K063569: Equinoxe Reverse Shoulder System (2007), cited by 16
- K053274: Anatomical Shoulder Inverse/Reverse (2006), cited by 13
- K041873: Aequalis Reversed Shoulder Prosthesis (2004), cited by 13

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