Alteon® HA Femoral Stems
FDA 510(k) K243839 · Exactech, Inc.
510(k) numberK243839
Submission
- Device name
- Alteon® HA Femoral Stems
- Applicant
- Exactech, Inc.
Gainesville, FL, US - Received
- December 13, 2024
- Decision date
- March 10, 2025
- 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
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|---|---|---|---|
| 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 |
| 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 |
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| 510(k) | Device | Decision |
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| K260583 | Equinoxe® Shoulder SystemPHX · Traditional | 04/14/2026SE |
| K250713 | Equinoxe® Humeral Reconstruction Prosthesis; Equinoxe® Stemless Shoulder ImplantsKWT · Traditional | 12/01/2025SE |
| K243448 | Equinoxe® Shoulder SystemPHX · Traditional | 08/01/2025SE |
| K243275 | Equinoxe® Scapula Fracture SystemHRS · Traditional | 06/26/2025SE |
| K240393 | Exactech® TRULIANT® Knee SystemMBH · Traditional | 10/03/2024SE |
| K233482 | Equinoxe® Central Screw Baseplate SystemPHX · Traditional | 07/18/2024SE |
| K230717 | Exactech® Vantage® Total Ankle SystemHSN · Traditional | 10/12/2023SE |
| K223933 | Exactech Equinoxe PHx Fracture System; Exactech EPIC ScrewsHRS · Traditional | 09/25/2023SE |
| K223833 | Exactech® Equinoxe® Reverse Humeral Liners and Humeral Adapter TraysPHX · Traditional | 09/14/2023SE |
| K232002 | Vantage® Total Ankle SystemHSN · Traditional | 09/11/2023SE |
Questions and answers
When was Alteon® HA Femoral Stems cleared by the FDA?
Alteon® HA Femoral Stems (K243839) received a 510(k) decision of Substantially Equivalent on March 10, 2025, 87 days after the submission was received.
What is the product code of K243839?
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.