# JDB: Prosthesis, Elbow, Semi-Constrained, Cemented

- Device class: 2; regulation: 21 CFR 888.3160; FDA's rule: 510(k) required
- FDA decisions: 27
- 510(k) review time 2021–2025: median 40 days (middle half 40–40)
- Recalls: 4 (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)
- 2001: 1
- 2003: 1
- 2005: 1
- 2006: 2
- 2007: 2
- 2010: 2
- 2017: 1
- 2018: 1
- 2020: 1
- 2022: 1

## Most-cited predicates
- K011567: Tornier Total Elbow Prosthesis (2001), cited by 4
- K955099: Sorbie Total Elbow System (1996), cited by 3
- K171010: Latitude EV Total Elbow Arthroplasty (2017), cited by 3
- K100562: Latitude Elbow Prosthesis (2010), cited by 3
- K031218: Modification to Tornier Total Elbow Prosthesis (2003), cited by 2
- K060438: RHS (2006), cited by 2
- K050848: Tornier Elbow Prosthesis (2005), cited by 2
- K810847: Pritchard Surface Replacement Elbow (1981), cited by 1
- K820957: Suface Replacement Elbow (1982), cited by 1
- K972691: Abc Total Elbow Prothesis (1997), cited by 1

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