Alteon® HA Femoral Stems— 510(k) K243839

Name: FDA 510(k) clearance K243839
Creator: U.S. Food and Drug Administration
Published: 2025-03-10

Substantially Equivalent

Exactech, Inc.

FDA 510(k) clearance K243839 for Alteon® HA Femoral Stems, Substantially Equivalent on 2025-03-10. Applicant: Exactech, Inc.. Device class: 2.

Clearance details

Applicant: Exactech, Inc.
Product code: Code MEH
Device class: Class 2
Regulation: 21 CFR 888.3353
Advisory panel: Orthopedic
Date received: 2024-12-13
Decision date: 2025-03-10
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Gainesville, FL, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code MEH

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K261576 — Icona Hip Stem2026-08-10
K250375 — Allure Hip Stem and Intramedullary Plugs2025-11-05
K251166 — Mfinity Femoral System2025-06-13
K251052 — Trivicta® Hip Stem2025-05-22
K242315 — Resolve Modular Revision Hip Stem2025-05-01

More clearances from Exactech, Inc.

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K260583 — Equinoxe® Shoulder System2026-04-14
K250713 — Equinoxe® Humeral Reconstruction Prosthesis; Equinoxe® Stemless Shoulder Implants2025-12-01
K243448 — Equinoxe® Shoulder System2025-08-01
K243275 — Equinoxe® Scapula Fracture System2025-06-26
K240393 — Exactech® TRULIANT® Knee System2024-10-03

Adverse events under product code MEH

product code MEH

Injury: 2,021
Total: 2,021

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

Data sourced from openFDA. This site is unofficial and independent of the FDA.