# K231522: EMPHASYS™ Dual Mobility System

- Pathway: 510(k) (Traditional)
- Applicant: Depuy Ireland UC
- Decided: Feb 15, 2024 after 265 days
- Product code: LPH (Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented)
- Device class: 2
- Regulation: 21 CFR 888.3358
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 4 generations back to K991990 (1999). 9 ancestors in all.
No later device cites it as a predicate yet.
0 of 10 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K200854: DePuy PINNACLE Dual Mobility Liner, Depuy Ireland UC (2020) Summary page 6.
- K181744: BI-MENTUM dual mobility system, Serf (2018) Summary page 6.

## Indications for use
Total hip replacement is indicated in the following conditions: 1. A severely painful and/or disabled joint (typically due to non-inflammatory degenerative joint disease). 2. Failed previous hip surgery. 3. Dislocation risks. EMPHASYS Dual Mobility Liners and Mobile Bearing Heads are intended for cementless applications.

Source page: https://510kreport.com/device/K231522
Methodology: https://510kreport.com/methodology