# JDI: Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented

- Device class: 2; regulation: 21 CFR 888.3350; FDA's rule: 510(k) required
- FDA decisions: 564
- 510(k) review time 2021–2025: median 116 days (middle half 59–202)
- Recalls: 172 (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: 1
- 2018: 1
- 2019: 2
- 2020: 7
- 2021: 3
- 2022: 3
- 2023: 2
- 2024: 3
- 2025: 1
- 2026: 2

## Most-cited predicates
- K002757: Oncology Salvage System (2000), cited by 21
- K052792: Anthology Hip Stem (2005), cited by 19
- K980513: Articul/Eze Femoral Heads (1998), cited by 12
- K032396: Ringloc 36MM Line and Modular Femoral Heads (2003), cited by 10
- K120578: Accolade II Hip Stem (2012), cited by 9
- K011623: Exeter Hip System with V40 Taper (2001), cited by 9
- K851422: S-Rom 135 Femoral Stem & Collar (Part of S-Rom Hip (1985), cited by 9
- K974054: Distal Centralizer, Exeter II Hip System (1997), cited by 8
- K990369: Synergy Cemented Hip Stem (1999), cited by 8
- K110290: Exeter Hip Stem (2011), cited by 7

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