# LGE: Prosthesis, Knee, Femorotibial, Semi-Constrained, Cemented, Trunnion-Bearing

- Device class: 2; regulation: 21 CFR 888.3530; FDA's rule: 510(k) required
- FDA decisions: 2
- Recalls: 1 (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)
- 1981: 1
- 1999: 1

## Most-cited predicates
- K992346: Kinematic II Rotating Hinge Knee (1999), cited by 1
- K811630: Kinematic Rotating Hinge Total Knee PR. (1981), cited by 1

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