# MBV: Prosthesis, Knee, Patello/Femorotibial, Semi-Constrained, Uhmwpe, Pegged, Cemented, Polymer/Metal/Polymer

- Device class: 2; regulation: 21 CFR 888.3560; FDA's rule: 510(k) required
- FDA decisions: 14
- 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)
- 1978: 2
- 1981: 1
- 1982: 1
- 1983: 6
- 1986: 1
- 1987: 1
- 1989: 1
- 2001: 1

## Most-cited predicates
- K010212: Offset Tibial Tray (2001), cited by 4
- K853730: Freeman-Samuelson Mark II Press-Fit Total Knee Rep (1986), cited by 2
- K884824: Tricon-M Total Knee System (1989), cited by 1
- K830726: Mark I & II Total Knee Replace. Sys (1983), cited by 1

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