EMPHASYS Acetabular Shell with RapiTite HA
510(k) K242084
Active
Valid until
No expiry
FDA recalls
None foundDocuments
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK242084 | Date7 Oct 2024 | StatusActive |
Recalls
No FDA recalls found in the data synced 22 Oct 2026.
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- 510(k) Number
- FDA product code
- LPH
- Device class
- Class II
- Regulation
- 21 CFR Part 888.3358
- Advisory committee
- Orthopedic
- FDA decision
- SESE Substantially Equivalent
Overview
AI-generated summary, 1 Oct 2026
The EMPHASYS Acetabular Shell with RapiTite HA is a modular, cementless, porous-coated acetabular component designed for hip arthroplasty. It features a hydroxyapatite (HA) coating applied conformally throughout the porous surface to enhance osseointegration and stability. Available in No-Hole, 3-Hole, and Multi-Hole configurations, it is intended for use in primary or revision total hip arthroplasty procedures. The device is classified under orthopedic nomenclature for acetabular replacements.
This device is supplied as a single-use implant, intended for surgical use in orthopedic settings. It requires sterile packaging and is regulated under FDA 510(k) clearance (K242084) as substantially equivalent to a predicate device. The modular design allows for customization to fit specific patient anatomy, and the porous coating promotes bone ingrowth for long-term fixation. No additional regulatory markings or MRI safety classifications are specified in the data.
Other devices from DePuy Ireland UC
Questions
AI-generated answers, 1 Oct 2026
What is the EMPHASYS Acetabular Shell with RapiTite HA used for?
The EMPHASYS Acetabular Shell with RapiTite HA is designed specifically for hip arthroplasty procedures, including both primary and revision total hip replacements. Its modular, cementless design and porous coating with hydroxyapatite (HA) promote bone ingrowth and long-term stability, making it suitable for patients requiring acetabular reconstruction.
How is the EMPHASYS Acetabular Shell with RapiTite HA supplied and what configurations are available?
This device is supplied as a single-use implant in sterile packaging, ensuring readiness for surgical use in orthopedic settings. It comes in three configurations: No-Hole, 3-Hole, and Multi-Hole, allowing surgeons to select the best fit for the patient’s anatomy and surgical needs.
Is the EMPHASYS Acetabular Shell with RapiTite HA intended for reuse or single-use?
The EMPHASYS Acetabular Shell with RapiTite HA is explicitly designed for single-use only. This ensures sterility and safety for each patient, reducing the risk of cross-contamination or infection associated with reused implants.
How does the hydroxyapatite (HA) coating contribute to its performance?
The hydroxyapatite (HA) coating applied conformally throughout the porous surface of the shell enhances osseointegration, which is the process where bone grows directly into the implant. This promotes stronger fixation and stability over time, improving long-term outcomes for patients undergoing hip arthroplasty.
What regulatory pathway does the EMPHASYS Acetabular Shell with RapiTite HA follow?
The device has received FDA 510(k) clearance under the classification K242084, determined to be substantially equivalent to a predicate device. This clearance confirms its compliance with U.S. regulatory standards for orthopedic acetabular replacements, ensuring its safety and effectiveness for intended use.