# JDO: Device, Fixation, Proximal Femoral, Implant

- Device class: 2; regulation: 21 CFR 888.3030; FDA's rule: 510(k) required
- FDA decisions: 24
- 510(k) review time 2021–2025: median 91 days (middle half 60–229)
- Recalls: 1 (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)
- 2008: 2
- 2014: 1
- 2016: 1
- 2017: 1
- 2018: 1
- 2020: 1
- 2021: 1
- 2022: 1
- 2023: 1
- 2026: 1

## Most-cited predicates
- K953607: Titanium Limited Contact Dynamic Hip Screw Plate (Tilc-DHS) (1996), cited by 8
- K923613: Synthes Limited Contact-Dynamic Hip Screw Implant (1993), cited by 5
- K152686: Conquest FN (2016), cited by 4
- K080434: Intertan CHS Locking Plate System Prox Fem Plates/Screw (2008), cited by 4
- K193029: Conquest FN (2020), cited by 3
- K983814: Gotfried Percutaneous Compression Plating System (1999), cited by 3
- K172785: Conquest FN (2017), cited by 2
- K981757: Synthes (Usa) DHS Helix System (1998), cited by 2
- K213126: Smith & Nephew, Inc. Plates and Screws Systems: EVOS, Peri-Loc, D-Rad, TC-100, VLP Mini-Mod, Compression Hip Screw (CHS), CONQUEST FN, and cannulated screws (2022), cited by 2
- K080685: Hiploc Compression Hip Screw (2008), cited by 1

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