# KRO: Prosthesis, Knee, Femorotibial, Constrained, Cemented, Metal/Polymer

- Device class: 2; regulation: 21 CFR 888.3510; FDA's rule: 510(k) required
- FDA decisions: 87
- 510(k) review time 2021–2025: median 60 days (middle half 57–94)
- Recalls: 49 (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)
- 2016: 3
- 2017: 1
- 2019: 3
- 2020: 1
- 2021: 3
- 2022: 1
- 2023: 4
- 2024: 3
- 2025: 3
- 2026: 1

## Most-cited predicates
- K023087: Global Modular Replacement System (GMRS) (2002), cited by 12
- K013385: Nexgen Complete Knee Solution Rotatng Hinge Knee (2002), cited by 9
- K092138: JTS Extendeable Implant (2011), cited by 7
- K161520: ELEOS Limb Salvage System (2016), cited by 6
- K002552: Howmedica Osteonics Modular Rotating Hinge Knee (2000), cited by 5
- K021489: Repiphysis Limb Salvage System (2002), cited by 5
- K110940: Zimmer Segment System Trabecular Metal Proximal Tibial Component, Trabecular Metal Proximal Component, Additional Segmen (2011), cited by 5
- K143179: The LINK® Endo-Model® Knee System (2015), cited by 5
- K896048: S-Rom/Noiles Mark 3 (1990), cited by 5
- K052685: Orthopedic Salvage System- Oss (2005), cited by 5

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