# MBL: Prosthesis, Hip, Semi-Constrained, Uncemented, Metal/Polymer, Porous

- Device class: 2; regulation: 21 CFR 888.3358; FDA's rule: 510(k) required
- FDA decisions: 13
- 510(k) review time 2021–2025: median 481 days (middle half 481–481)
- Recalls: 3 (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)
- 2006: 1
- 2007: 1
- 2009: 1
- 2010: 1
- 2011: 1
- 2012: 2
- 2016: 1
- 2018: 1
- 2020: 1
- 2021: 1

## Most-cited predicates
- K070756: Smith and Nephew Reflection 3 Acetabular System (2007), cited by 15
- K092386: R3 Multi-Hole Shells and 36MM Xlpe Acetabular Liners (2009), cited by 11
- K061253: Reflection 3 Acetabular System (2006), cited by 11
- K093363: Cocr and Oxinium Femoral Heads and R3 Xlpe Liners (2010), cited by 7
- K113848: R3 Xlpe Liners (2012), cited by 5
- K102370: R3 Xlpe Anteverted Liners (2011), cited by 3
- K960094: Reflection Dual Dimension Shell (1996), cited by 3
- K122382: Dynasty Biofoam Shell (2012), cited by 3
- K182535: R3 Anteverted Liners (2018), cited by 1
- K161233: OXINIUM DH Fermoral Heads (2016), cited by 1

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