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FDA 510(k)

Icona Hip Stem

K-Number: K261576 · 2026-08-10

ApplicantCorin, Ltd.
Decision Date2026-08-10
Product CodeMEH
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

Icona Hip Stem is the device name listed in this FDA 510(k) record. The listed applicant is Corin, Ltd.. It received FDA 510(k) clearance on 2026-08-10 under 510(k) number K261576. The device is classified under product code MEH. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Icona Hip Stem?

Icona Hip Stem is a medical device that received FDA 510(k) clearance on 2026-08-10. The listed applicant is Corin, Ltd.. The 510(k) number is K261576.

When did Icona Hip Stem receive FDA 510(k) clearance?

Icona Hip Stem received FDA 510(k) clearance on 2026-08-10, under 510(k) number K261576.

Who is the listed applicant for Icona Hip Stem?

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

What is the FDA product code for Icona Hip Stem?

The FDA product code for Icona Hip Stem is MEH.

Other records listing Corin, Ltd. 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.

K201657Corin Ltd. Hip Products: Trinity™ Acetabular System, Trinity™ PLUS Acetabular Shell, MetaFix™ Hip System, TriFit™ CF and TS Hip Systems, TaperFit™ Hip System, Revival™ Modular Hip System, MiniHip™, Trinity™ Dual Mobility, MobiliT, BiPolar-i, OMNI MOD™ Hip System, OMNI K1 and K2 Hip Systems, OMNI Bipolar Heads, Corin Biolox Delta Ceramic Heads, OMNI Delta Ceramic HeadsK200888OMNIBotics Knee System

Related Devices (Code: MEH)

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.

K250375Allure Hip Stem and Intramedullary PlugsWaldemar Link GmbH & Co. KGK251166Mfinity Femoral SystemMedacta International S.A.K251052Trivicta® Hip StemOrtho Development Corp.K242315Resolve Modular Revision Hip StemUnited Orthopedic CorporationK243839Alteon® HA Femoral StemsExactech, Inc.K243162World LinerSignature Orthopaedics Pty, Ltd.

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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