# MBF: Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer, Uncemented

- Device class: 2; regulation: 21 CFR 888.3670; FDA's rule: 510(k) required
- FDA decisions: 37
- 510(k) review time 2021–2025: median 104 days (middle half 57–245)
- Recalls: 14 (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: 2
- 2018: 1
- 2019: 2
- 2020: 2
- 2021: 1
- 2022: 4
- 2023: 4
- 2024: 2
- 2025: 2
- 2026: 1

## Most-cited predicates
- K060692: Comprehensive Primary Shoulder Stems (2006), cited by 15
- K202716: Ignite Anatomic Shoulder System (2021), cited by 5
- K011047: Global Advantage Humeral Stem with Porocoat (2001), cited by 5
- K193038: Comprehensive Shoulder System (2020), cited by 4
- K163397: SMR Hybrid Glenoid System (2017), cited by 4
- K112905: Compress (R) Segmental Humeral Replacement System (2012), cited by 3
- K011099: Global FX Porous-Coated Humeral Stem (2001), cited by 3
- K213856: Identity Shoulder System (2022), cited by 3
- K220792: SMR Reverse Liner (2022), cited by 3
- K083439: Synthes Epoca Shoulder Prosthesis System (2009), cited by 3

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