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

- Device class: 2; regulation: 21 CFR 888.3358; FDA's rule: 510(k) required
- FDA decisions: 565
- 510(k) review time 2021–2025: median 156 days (middle half 76–272)
- Recalls: 183 (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: 12
- 2018: 9
- 2019: 22
- 2020: 7
- 2021: 8
- 2022: 14
- 2023: 10
- 2024: 6
- 2025: 12
- 2026: 8

## Most-cited predicates
- K043537: Taperloc 12/14 Taper Femoral Components (2005), cited by 20
- K000306: Pinnacle Acetabular System (2000), cited by 18
- K091508: Zimmer Continuum Acetabular System, Zimmer Trilogy IT Acetabular System (2009), cited by 18
- K103721: Mpact Acetabular System (2011), cited by 16
- K001534: Pinnacle Acetabular System (2000), cited by 15
- K921301: Taperloc Femoral Stem and Universal Acetabular Com (1994), cited by 14
- K121297: Origin Hip Stem, Femoral Head, Logical PX-Series Acetabular Shell, Locigal G-Series Acetabular Shell, Logical Acetabular (2012), cited by 12
- K100445: Klassic HD Hip System (2010), cited by 12
- K934765: Trilogy Acetabular System (1994), cited by 12
- K002149: Lineage Acetabular System (2000), cited by 11

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