FDA.reportPublic FDA data

510(k) K252451

Device
EPORE® XO cup system
Applicant
Implantcast GmbH
510(k) number
K252451
Product code
OQI
Decision
Substantially Equivalent (SESE)
Decision date
2026-04-24
Date received
2025-08-04
Regulation
888.3353
Classification name
Hip, Semi-Constrained, Cemented, Metal/Ceramic/Polymer + Additive, Porous Uncemented
Medical specialty
Orthopedic
Review panel
Orthopedic
Device class
2
Clearance type
Traditional
Statement or summary
Summary
Third party reviewed
N

Applicant Contact#

Contact
Juliane Höppner
Address
Lüneburger Schanze 26 Buxtehude DE 21614 21614

FDA Registration Numbers#

Source Documents#

510(k) summary PDF

Other 510(k) Records For Product Code OQI#

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K192989Libertas E-XLPE Modular LinerMaxx Orthopedics, Inc.2020-10-29
K172833E-XPE Acetabular Components and U-Motion II Acetabular CupUnited Orthopedic Corporation2018-06-12
K173583Exactech® Novation® and AcuMatch® E-HXL Acetabular LinersExactech, Inc.2018-03-12
K111481CORIN TRINITY ACETABULAR SYSTEM ECIMA LINERSCorin USA2012-02-06