# MEH: Prosthesis, Hip, Semi-Constrained, Uncemented, Metal / Polymer, Non-Porous, Calcium Phosphate

- Device class: 2; regulation: 21 CFR 888.3353; FDA's rule: 510(k) required
- FDA decisions: 160
- 510(k) review time 2021–2025: median 105 days (middle half 67–179)
- Recalls: 174 (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: 3
- 2018: 2
- 2019: 1
- 2020: 3
- 2021: 3
- 2022: 3
- 2023: 2
- 2024: 6
- 2025: 5
- 2026: 1

## Most-cited predicates
- K093472: Trinity Acetabular System (2010), cited by 19
- K150862: DePuy Actis Duofox Hip Prosthesis (2015), cited by 14
- K002996: Synergy HA Coated Porous Femoral  Stems (2000), cited by 11
- K103479: Novel Tapered Hip Stem (2011), cited by 10
- K160907: DePuy Actis DuoFix Hip Prosthesis (2016), cited by 10
- K983382: Osteonics HA Generation II Acetabular Component System (1998), cited by 10
- K072020: Restoration Adm System (2007), cited by 10
- K080584: Metha Short Stem Hip System (2008), cited by 9
- K083116: Versafit Cup Double Mobility System (2009), cited by 8
- K071916: Metha Hip System (2008), cited by 7

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