# LZO: Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented

- Device class: 2; regulation: 21 CFR 888.3353; FDA's rule: 510(k) required
- FDA decisions: 535
- 510(k) review time 2021–2025: median 144 days (middle half 63–260)
- Recalls: 120 (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)
- 2017: 16
- 2018: 18
- 2019: 28
- 2020: 18
- 2021: 12
- 2022: 11
- 2023: 10
- 2024: 11
- 2025: 14
- 2026: 9

## Most-cited predicates
- K042992: Corail Amt Hip Prosthesis (2005), cited by 27
- K110087: Corin Trinity Acetbular System with Hxlpe Liners (2011), cited by 16
- K071535: Biolox Delta Ceramic Femoral Head (2007), cited by 15
- K103233: Modular Dual Mobility Liner, X3 Acetabular Insert (2011), cited by 11
- K082525: Corin Metafix Femoral Stem (2010), cited by 10
- K111572: Novae Sunfit TH Dual Mobility Acetabular Cup Model Sunfit TH (Metal-Back), Novae E TH Dual Mobility Acetabular Cup Model (2011), cited by 10
- K953111: Corail (1996), cited by 10
- K083762: Biolox Delta Ceramic Femoral Heads (2009), cited by 9
- K060918: Excia Total Hip System 12/14 Trunnion with Ceramic Head (2006), cited by 9
- K120362: Metafix Femoral Stem for Hemi-Arthroplasty (2012), cited by 9

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