Icona Hip Stem
FDA 510(k) K241472 · Corin U.S.A. Limited
510(k) numberK241472
Submission
- Device name
- Icona Hip Stem
- Applicant
- Corin U.S.A. Limited
Tampa, FL, US - Received
- May 24, 2024
- Decision date
- October 3, 2024
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
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 |
|---|---|---|---|
| K261576 | Icona Hip StemMEH · Traditional | Corin, Ltd. | 08/10/2026SE |
| 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 |
| 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 |
|---|---|---|
| K242744 | Trinity EVO Acetabular ShellLPH · Traditional | 06/05/2025SE |
| K241808 | ApolloHipX (THR.SS.0001)LLZ · Traditional | 01/07/2025SE |
| K241570 | Unity Total Knee SystemJWH · Traditional | 09/23/2024SE |
| K240875 | Unity Knee PS-C Tibial InsertJWH · Traditional | 06/26/2024SE |
| K231172 | ApolloKneeOLO · Traditional | 07/26/2023SE |
| K212069 | Corin MetaFix Hip StemLZO · Traditional | 04/07/2022SE |
| K191831 | MobiliT CupLZO · Traditional | 01/16/2020SE |
| K191374 | Revival Modular Hip StemLZO · Traditional | 07/22/2019SE |
| K183114 | Corin BiPolar-iKWY · Traditional | 06/05/2019SE |
| K183533 | Unity Total Knee SystemJWH · Traditional | 06/04/2019SE |
Questions and answers
When was Icona Hip Stem cleared by the FDA?
Icona Hip Stem (K241472) received a 510(k) decision of Substantially Equivalent on October 3, 2024, 132 days after the submission was received.
What is the product code of K241472?
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.