# K242084: EMPHASYS Acetabular Shell with RapiTite HA

- Pathway: 510(k) (Traditional)
- Applicant: Depuy Ireland UC
- Decided: Oct 7, 2024 after 83 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.
No later device cites it as a predicate yet.
0 of 287 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 6.
- 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 6.
- K031495: Pinnacle Duofix HA Acetabular Cup Prosthesis, DePuy Orthopaedics, Inc. (2003) Summary page 6.
- K090998: Depuy Pinnacle 100 with Gription Acetabular Cups, DePuy Orthopaedics, Inc. (2009) Summary page 6.
- K093646: Depuy Pinnacle with Gription Acetabular Cups, DePuy Orthopaedics, Inc. (2009) Summary page 6.

## Indications for use
Total hip arthroplasty is intended to provide increased patient mobility and reduce pain by replacing the damaged hip joint articulation in patients where there is evidence of sufficient sound bone to seat and support the components. The EMPHASYS Acetabular Shell with RapiTite HA is intended for single use only. INDICATIONS 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 Shell with RapiTite HA is indicated for cementless use only.

Source page: https://510kreport.com/device/K242084
Methodology: https://510kreport.com/methodology