EPORE XO Cup System
FDA 510(k)EUDAMEDClass II (US FDA 510(k))
Identity
- Trade Name
- EPORE® EUDAMED
- Device Name
- - EUDAMED
- Model / Reference
- MUT12DITINST EUDAMED77801030 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 04048844438609 EUDAMED
- Basic UDI-DI
- 4048844MUT12DITINSTH6 EUDAMED
- 510(k) Number
- K252451 FDA 510(k)
- FDA Product Code
- OQI FDA 510(k)
- EMDN Code
- L091199 ORTHOPAEDIC PROSTHETICS INSTRUMENTS, REUSABLE - OTHER EUDAMED
Classification
- Device Class
- Class IIa EUDAMEDClass II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 888.3353 FDA 510(k)
- Regulation Number
- 888.3353 FDA 510(k)
- Market of Registration
- Germany EUDAMED
- Advisory Committee
- Orthopedic FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
Clinical & Handling
Sterile
No
Implantable
No
Reusable
No
Contains Latex
No
Reprocessed
No
CMR Substance
Yes
Human-derived
No
Human Tissues
No
Animal Tissues
No
Endocrine Disruptor
No
Administering Medicine
No
Measuring Function
No
Incorporates Medicinal Product
No
The EPORE XO Cup System is a semi-constrained hip implant designed for cemented or porous uncemented fixation, combining metal, ceramic, and polymer components. It is classified as a hip prosthesis and serves as an orthopedic solution for total hip arthroplasty, providing stability and articulation for the femoral head within the acetabular component.
This system is supplied sterile and intended for single-use in orthopedic surgical settings. It is classified under FDA device class II and has received FDA 510(k) clearance and MDR authorization. The system includes various sizes and configurations, as referenced by the listed FEI numbers, and must be handled according to sterile surgical protocols. No MRI safety information is specified in the provided data.
Frequently asked questions
What types of fixation options are available with the EPORE® XO cup system, and how does this affect its use in surgery?
The EPORE® XO cup system is designed for two distinct fixation methods: cemented or porous uncemented. This flexibility allows surgeons to choose based on patient-specific factors like bone quality, age, or clinical needs. Cemented fixation is ideal for patients with weaker bone density, while porous uncemented fixation may be preferred for younger, more active patients or those requiring long-term stability without cement.
How many sizes and configurations are available for the EPORE® XO cup system, and how are they identified?
The system includes a wide range of sizes and configurations, each identified by unique FEI numbers (e.g., 3000215103, 3004748528, etc.). Over 100 distinct FEI numbers are listed, ensuring compatibility with various patient anatomies and surgical requirements. These numbers correspond to specific acetabular cup designs, sizes, and orientations to optimize fit and function during total hip arthroplasty.
Is the EPORE® XO cup system intended for reuse in surgical settings, and what are the handling requirements?
No, the EPORE® XO cup system is explicitly intended for single-use only in sterile surgical settings. As it is supplied sterile, it must be handled according to strict aseptic protocols to maintain sterility until implantation. Reuse is not permitted, as this could compromise patient safety and device integrity.
What materials are used in the construction of the EPORE® XO cup system, and how do they contribute to its function?
The system combines metal, ceramic, and polymer components to create a semi-constrained hip prosthesis. The metal and ceramic components provide durability and wear resistance, while the polymer elements enhance articulation and stability. This combination ensures long-term performance, reduced friction, and improved load distribution for the femoral head within the acetabular cup.
What regulatory pathways has the EPORE® XO cup system undergone, and what does this mean for its use in clinical practice?
The system has received FDA 510(k) clearance under the Traditional 510(k) pathway and MDR authorization, confirming its compliance with U.S. and EU regulatory standards. This means it has been evaluated for safety and effectiveness by regulatory bodies, ensuring it meets established performance criteria for hip prostheses. Clinicians can rely on its regulatory approval when selecting it for total hip arthroplasty procedures.
This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them.
Authorization Coverage (2 countries)
Regulatory Authorizations
MDR
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | MDR | — | Class II | Active |
| FDA 510(k) | United States | FDA_510K | K252451 | Class II | Active |
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Manufacturer
- Manufacturer
- implantcast GmbH
Sources (2)
- FDA 510(k) K252451 24 fields · synced Oct 6, 2026
- EUDAMED dc18517c-ddcc-4ff8-b6d0-1a14348560a2 61 fields · synced Sep 17, 2026