# MAY: Prosthesis,  Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous Cemented, Osteophilic Finish

- Device class: 2; regulation: 21 CFR 888.3353; FDA's rule: 510(k) required
- FDA decisions: 4
- Recalls: 19 (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)
- 2005: 1
- 2009: 1
- 2011: 1
- 2013: 1

## Most-cited predicates
- K123604: Abg Iii Monolithic Hip Stem (2013), cited by 3
- K090103: 100KGY E-Poly Acetabular Liners- Additional Profiles: +3 Maxrom and +3 HI-Wall (2009), cited by 2
- K110807: Abg II Monolithic Hip Stem (2011), cited by 1

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