# K243977: EMPHASYS Acetabular System

- Pathway: 510(k) (Special)
- Applicant: Depuy Ireland UC
- Decided: Jan 22, 2025 after 30 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: 19 generations back to K941847 (1994). 287 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 288 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K221636: EMPHASYS Acetabular System, Depuy Ireland UC (2022) Summary page 5.
- K071784: Depuy Pinnacle with Gripton Acetabular Cups, DePuy Orthopaedics, Inc. (2007) Summary page 5.
- K231873: DePuy SUMMIT Porocoat Hip Prosthesis – MR Conditional, DePuy SUMMIT DuoFix Hip Prosthesis – MR Conditional, DePuy SUMMIT Cemented Hip Prosthesis – MR Conditional, DePuy SUMMIT FX Cemented Hip Prosthesis – MR Conditional, DePuy SUMMIT Basic Press-Fit Hip Prosthesis – MR Conditional, Depuy Ireland UC (2024) Summary page 5.

## Most influential descendants
- K252067: Velora Acetabular System (2025), 0 descendants of its own

## Indications for use
The EMPHASYS Acetabular System is indicated for use in total hip replacement procedures. Total hip replacement is indicated in the following conditions: 1. A severely painful and/or disabled joint from osteoarthritis, traumatic arthritis, rheumatoid arthritis, or congenital hip dysplasia. 2. Avascular necrosis of the femoral head. 3. Acute traumatic fracture of the femoral head or neck. 4. Failed previous hip surgery including joint reconstruction, internal fixation, arthrodesis, hemiarthroplasty, surface replacement arthroplasty, or total hip replacement. 5. Certain cases of ankylosis. EMPHASYS Acetabular Cups are indicated for cementless use only.

Source page: https://510kreport.com/device/K243977
Methodology: https://510kreport.com/methodology