# MBD: Prosthesis, Knee, Patello/Femorotibial, Unconstrained, Uncemented, Porous, Coated, Polymer/Metal/Polymer

- Device class: 3; regulation: 21 CFR —; FDA's rule: PMA required
- FDA decisions: 1
- 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)
- 1995: 2
- 1996: 1
- 1997: 4
- 1998: 2
- 1999: 1
- 2000: 1
- 2001: 1
- 2002: 1
- 2003: 1
- 2005: 2

## Most-cited predicates
- P940002: Natural-Knee (R) and Natural Knee (R)II W/Csti (TM) (1997), cited by 2

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