# OQI: Hip, Semi-Constrained, Cemented, Metal/Ceramic/Polymer + Additive, Porous Uncemented

- Device class: 2; regulation: 21 CFR 888.3353; FDA's rule: 510(k) required
- FDA decisions: 5
- Recalls: 2 (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)
- 2012: 1
- 2018: 2
- 2020: 1
- 2026: 1

## Most-cited predicates
- K111481: Corin Trinity Acetabular System Ecima Liners (2012), cited by 8
- K173583: Exactech® Novation® and AcuMatch® E-HXL Acetabular Liners (2018), cited by 1
- K172833: E-XPE Acetabular Components and U-Motion II Acetabular Cup (2018), cited by 1

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