# HSD: Prosthesis, Shoulder, Hemi-, Humeral, Metallic Uncemented

- Device class: 2; regulation: 21 CFR 888.3690; FDA's rule: 510(k) required
- FDA decisions: 71
- 510(k) review time 2021–2025: median 78 days (middle half 49–107)
- Recalls: 9 (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)
- 2008: 3
- 2011: 2
- 2012: 2
- 2013: 4
- 2014: 1
- 2016: 3
- 2018: 1
- 2020: 2
- 2022: 1
- 2024: 1

## Most-cited predicates
- K031971: Global Cap Resurfacing Replacement Shoulder (2003), cited by 9
- K003044: Copeland Resurfacing Heads (2000), cited by 7
- K063578: Promos Modular Shoulder System (2007), cited by 6
- K954559: Howmedicca Modular Proximal Humerus Replacement System (1996), cited by 5
- K010657: Copeland MB Resurfacing Humeral Heads (2001), cited by 5
- K032126: Promos Shoulder (2004), cited by 5
- K112983: Spacer-S (2011), cited by 4
- K010664: Copeland Resurfacing Humeral Heads (2001), cited by 4
- K010827: Copeland MB/HA Resurfacing Humeral Heads (2001), cited by 4
- K051843: Copeland Eas Humeral Resurfacing Heads (2005), cited by 4

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