Icona Hip Stem

Q: When was Icona Hip Stem cleared by the FDA?

Icona Hip Stem (K261576) received a 510(k) decision of Substantially Equivalent on August 10, 2026, 90 days after the submission was received.

Q: What is the product code of K261576?

The FDA product code is MEH – Prosthesis, Hip, Semi-Constrained, Uncemented, Metal / Polymer, Non-Porous, Calcium Phosphate, a Class II (moderate risk) device regulated under 21 CFR 888.3353.

FDA 510(k) K261576 · Corin, Ltd.

Substantially Equivalent

510(k) numberK261576

Submission

Device name: Icona Hip Stem
Applicant: Corin, Ltd.
Cirencester, GB
Received: May 12, 2026
Decision date: August 10, 2026
Decision: Substantially Equivalent (SESE)
Type: Traditional 510(k)
Summary: 510(k) summary available from FDA

Official FDA 510(k) record

Device classification

Product code: MEH – Prosthesis, Hip, Semi-Constrained, Uncemented, Metal / Polymer, Non-Porous, Calcium Phosphate
Device class: Class II (moderate risk)
Regulation: 21 CFR 888.3353
Specialty: Orthopedic
Implant: Yes

Other 510(k)s with product code MEH

510(k)	Device	Applicant	Decision
K250375	Allure Hip Stem and Intramedullary PlugsMEH · Traditional	Waldemar Link GmbH & Co. KG	11/05/2025SE
K251166	Mfinity Femoral SystemMEH · Traditional	Medacta International S.A.	06/13/2025SE
K251052	Trivicta® Hip StemMEH · Traditional	Ortho Development Corp.	05/22/2025SE
K242315	Resolve Modular Revision Hip StemMEH · Traditional	United Orthopedic Corporation	05/01/2025SE
K243839	Alteon® HA Femoral StemsMEH · Traditional	Exactech, Inc.	03/10/2025SE
K243162	World LinerMEH · Special	Signature Orthopaedics Pty, Ltd.	11/25/2024SE
K241472	Icona Hip StemMEH · Traditional	Corin U.S.A. Limited	10/03/2024SE
K241875	TheRay Collared and Collarless Femoral StemMEH · Traditional	Nextstep Arthropedix	09/13/2024SE
K241690	Logical Liner; World Liner; World Knee PatellaMEH · Special	Signature Orthopaedics Pty, Ltd.	08/01/2024SE
K233758	Trivicta Hip StemMEH · Traditional	Ortho Development Corp.	03/08/2024SE

More from Ortho Development Corp.

510(k)	Device	Decision
K201657	Corin Ltd. Hip Products: Trinity Acetabular System, Trinity PLUS Acetabular Shell…LZO · Traditional	07/28/2021SE
K200888	OMNIBotics Knee SystemOLO · Traditional	06/27/2020SE

Questions and answers

When was Icona Hip Stem cleared by the FDA?

Icona Hip Stem (K261576) received a 510(k) decision of Substantially Equivalent on August 10, 2026, 90 days after the submission was received.

What is the product code of K261576?

The FDA product code is MEH – Prosthesis, Hip, Semi-Constrained, Uncemented, Metal / Polymer, Non-Porous, Calcium Phosphate, a Class II (moderate risk) device regulated under 21 CFR 888.3353.