FDA 510(k)

EPORE® XO cup system

K-Number: K252451 · 2026-04-24

Decision Date2026-04-24

Product CodeOQI

Advisory CommitteeOR

DecisionSubstantially Equivalent

Device Summary

EPORE® XO cup system is a medical device manufactured by Implantcast GmbH. It received FDA 510(k) clearance on 2026-04-24 under approval number K252451. The device is classified under product code OQI. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the EPORE® XO cup system?

EPORE® XO cup system is a medical device that received FDA 510(k) clearance on 2026-04-24. It is manufactured by Implantcast GmbH. The 510(k) number is K252451.

When was EPORE® XO cup system approved by the FDA?

EPORE® XO cup system received FDA 510(k) clearance on 2026-04-24, under approval number K252451.

What company makes EPORE® XO cup system?

EPORE® XO cup system is manufactured by Implantcast GmbH.

What is the FDA product code for EPORE® XO cup system?

The FDA product code for EPORE® XO cup system is OQI.

Other Devices by Implantcast GmbH

K163577Ecofit® Hip System K180263EcoFit Vit E Acetabular System K191569Implantcast ic-Bipolar Head System K181778MUTARS Proximal Femur Replacement System K191433AGILON® XO Shoulder Replacement System K200045MUTARS Cemented Femoral Stems

View all 20 devices →

Related Devices (Code: OQI)

K172833E-XPE Acetabular Components and U-Motion II Acetabular CupUnited Orthopedic Corporation K173583Exactech® Novation® and AcuMatch® E-HXL Acetabular LinersExactech, Inc. K192989Libertas E-XLPE Modular LinerMaxx Orthopedics, Inc.

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.