EPORE® XO cup system— 510(k) K252451

Name: FDA 510(k) clearance K252451
Creator: U.S. Food and Drug Administration
Published: 2026-04-24

Substantially Equivalent

Implantcast GmbH

FDA 510(k) clearance K252451 for EPORE® XO cup system, Substantially Equivalent on 2026-04-24. Applicant: Implantcast GmbH. Device class: 2.

Summary

Implantcast GmbH's EPORE XO cup system is filed under product code OQI (Hip, Semi-Constrained, Cemented, Metal/Ceramic/Polymer + Additive, Porous Uncemented).

Class II, 21 CFR 888.3353. Orthopedic is both the classification panel and the review panel. It came in as a Traditional 510(k).

Implantcast filed from Buxtehude, Germany. The record shows 263 calendar days from receipt to decision (August 4, 2025 to April 24, 2026).

Clearance details

Applicant: Implantcast GmbH
Product code: Product code OQI
Device class: Class 2
Regulation: 21 CFR 888.3353
Advisory panel: Orthopedic
Date received: 2025-08-04
Decision date: 2026-04-24
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Buxtehude, DE

Download summary PDF View on FDA.gov ↗

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Data sourced from openFDA. This site is unofficial and independent of the FDA.