Depuy Pinnacle Acetabular Cup System, ESL Marathon Polyethylene Liners, and Depuy Ultima Unipolar Femoral Heads
510(k) K033273
Active
Valid until
No expiry
FDA recalls
None foundDocuments
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK033273 | Date6 May 2004 | 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- Withdrawn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, 20 Sep 2026
The Depuy Pinnacle Acetabular Cup System is a modular orthopaedic implant designed for cementless total hip arthroplasty. It includes acetabular cups, ESL Marathon polyethylene liners, and Depuy Ultima unipolar femoral heads, providing options for biological and mechanical fixation. The system is intended to resurface the acetabular socket, restoring joint function and mobility in hip replacement procedures. Its modular components allow customisation to match anatomical requirements and clinical needs.
This system is supplied as a sterile, single-use orthopaedic implant for surgical use in accredited operating theatres. The Depuy Pinnacle Acetabular Cup System, along with the ESL Marathon liners and Ultima femoral heads, holds an FDA 510(k) clearance under the Traditional pathway, classified under product code LPH. Components are intended for use in cementless total hip arthroplasty and hemi-arthroplasty procedures, adhering to orthopaedic surgical standards. Storage and handling must comply with sterile medical device protocols.
Other devices from Depuy Orthopaedics, Inc.
Questions
AI-generated answers, 20 Sep 2026
What types of hip procedures is this system designed for, and how does its modularity benefit surgeons?
The Depuy Pinnacle Acetabular Cup System is specifically designed for cementless total hip arthroplasty and hemi-arthroplasty procedures. Its modularity allows surgeons to customise the acetabular cup, ESL Marathon polyethylene liners, and Depuy Ultima unipolar femoral heads to match the anatomical and clinical needs of each patient, ensuring a tailored fit for optimal joint function and stability.
Is this system intended for reuse, or is it meant to be used once per patient?
This system is explicitly supplied as a sterile, single-use orthopaedic implant. Each component—acetabular cup, liners, and femoral heads—is intended for one-time use in a single surgical procedure, adhering to standard sterile medical device protocols to prevent cross-contamination.
How should the components of this system be stored to maintain sterility before use?
The Depuy Pinnacle Acetabular Cup System, including the ESL Marathon liners and Ultima femoral heads, must be stored and handled according to sterile medical device protocols. This ensures the integrity of the sterile barrier until the components are ready for use in an accredited operating theatre, minimising the risk of contamination.
What regulatory pathway was followed for FDA clearance of this system, and what does that classification mean for its intended use?
The system holds FDA 510(k) clearance under the Traditional pathway, classified under product code LPH (Orthopedic Devices for Hip Replacement). This classification confirms the device was determined to be *substantially equivalent* to a legally marketed predicate, meaning it meets the same performance standards and intended use as previously approved hip replacement systems.
Are the femoral heads included in this system unipolar or bipolar, and what does that imply for surgical planning?
The system includes Depuy Ultima *unipolar* femoral heads, meaning they consist of a single component (head and stem) rather than a modular neck. This design simplifies surgical planning and reduces the risk of component failure due to modular interfaces, though it may limit flexibility in certain revision cases where modularity is preferred.