# JDC: Prosthesis, Elbow, Constrained, Cemented

- Device class: 2; regulation: 21 CFR 888.3150; FDA's rule: 510(k) required
- FDA decisions: 29
- Recalls: 17 (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: 2
- 2003: 1
- 2004: 2
- 2005: 2
- 2006: 1
- 2009: 1
- 2013: 1
- 2015: 1
- 2016: 1
- 2019: 2

## Most-cited predicates
- K013042: Discovery Elbow (2001), cited by 5
- K033280: Discovery Elbow-Mosaic Distal Humeral Replacement System (2003), cited by 5
- K883665: Coonrad Iii Total Elbow (1989), cited by 4
- K000003: Tornier Total Elbow Prosthesis (2000), cited by 4
- K001989: Coonrad/Morrey Total Elbow. Model 32-8105 Series (2000), cited by 4
- K053189: Coonrad/Morrey Total Elbow, Model 8105 Series (2005), cited by 4
- K051975: Porous Coated Discovery Elbow (2005), cited by 3
- K861680: Osteonics Elbow Prosthesis (1986), cited by 3
- K973357: Coonrad/Morrey Total Elbow, New Hinge Pin (1998), cited by 3
- K980502: Osteonics Total Elbow System (1998), cited by 2

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