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FDA 510(k)

EPORE® XO cup system

K-Number: K252451 · 2026-04-24

ApplicantImplantcast GmbH
Decision Date2026-04-24
Product CodeOQI
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

EPORE® XO cup system is the device name listed in this FDA 510(k) record. The listed applicant is Implantcast GmbH. It received FDA 510(k) clearance on 2026-04-24 under 510(k) 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. The listed applicant is Implantcast GmbH. The 510(k) number is K252451.

When did EPORE® XO cup system receive FDA 510(k) clearance?

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

Who is the listed applicant for EPORE® XO cup system?

The FDA 510(k) record lists Implantcast GmbH as the applicant. This does not by itself establish the device manufacturer.

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

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

Other records listing Implantcast GmbH as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K260037implantcast Packaging System UpdateK252401implaFit® short stemsK241944AGILON® XO Shoulder Replacement SystemK240391MUTARS® femoral stem cemented 160 mm and 200 mmK234044ACS® LD FB Knee SystemK240834EcoFit® short stem cementless cpTi

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Related Devices (Code: OQI)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K192989Libertas E-XLPE Modular LinerMaxx Orthopedics, Inc.K172833E-XPE Acetabular Components and U-Motion II Acetabular CupUnited Orthopedic CorporationK173583Exactech® Novation® and AcuMatch® E-HXL Acetabular LinersExactech, 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.

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