# K221636: EMPHASYS Acetabular System

- Pathway: 510(k) (Traditional)
- Applicant: Depuy Ireland UC
- Decided: Sep 6, 2022 after 92 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: 7 generations back to K930712 (1993). 18 ancestors in all.
7 later devices descend from it; 4 cite it directly.
0 of 26 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K071784: Depuy Pinnacle with Gripton Acetabular Cups, DePuy Orthopaedics, Inc. (2007) Summary page 4.
- K093646: Depuy Pinnacle with Gription Acetabular Cups, DePuy Orthopaedics, Inc. (2009) Summary page 4.
- K132959: Depuy Pinnacle Altrx Acetabular Liners, DePuy Orthopaedics, Inc. (2014) Summary page 4.
- K033273: Depuy Pinnacle Acetabular Cup System, Esl Marathon Polyethylene Liners, and Depuy Ultima Unipolar Femoral Heads, DePuy Orthopaedics, Inc. (2004) Summary page 4.

## Most influential descendants
- 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 (2024), 5 descendants of its own
- K251292: RECLAIM Monobloc Revision Femoral Stem (2025), 1 descendant of its own
- K243977: EMPHASYS Acetabular System (2025), 1 descendant of its own
- K260173: M-Vizion Femoral Revision System Extension (2026), 0 descendants of its own
- K253948: Momentum Acetabular Cup System (2026), 0 descendants of its own

## Indications for use
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/K221636
Methodology: https://510kreport.com/methodology