# MBH: Prosthesis, Knee, Patello/Femorotibial, Semi-Constrained, Uncemented, Porous, Coated, Polymer/Metal/Polymer

- Device class: 2; regulation: 21 CFR 888.3565; FDA's rule: 510(k) required
- FDA decisions: 146
- 510(k) review time 2021–2025: median 83 days (middle half 52–127)
- Recalls: 44 (5 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026; MAUDE to Sep 30, 2026

## Decisions per year (last 10)
- 2017: 4
- 2018: 6
- 2019: 1
- 2020: 7
- 2021: 6
- 2022: 7
- 2023: 6
- 2024: 10
- 2025: 8
- 2026: 7

## Most-cited predicates
- K141056: Triathlon Knee System Posterior Stabilized Components (2014), cited by 13
- K121771: Zimmer Persona the Personalized Knee System (2012), cited by 9
- K053340: Trabecular Metal Tibial and Femoral Cone Augments (2006), cited by 9
- K033489: Agc Total Knee System Knee, Ascent Total Knee System, Maxim Complete Knee System, Maxim Accel Knee System Also Known (2004), cited by 9
- K030612: Genesis II Total Knee System (2003), cited by 9
- K123486: Triathlon Tritanium Tibial Baseplate (2013), cited by 9
- K110950: Consensus Knee System (2011), cited by 8
- K051380: Triathlon Press-Fit Total Knee System (2005), cited by 8
- K031061: Nexgen Porous, Uncemented Femoral and Tibial Baseplate Components (2003), cited by 8
- K102896: Trabecular Metal Tibial Cone Augments (2010), cited by 7

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