HYALEX® MTP Hemiarthroplasty Implant— 510(k) K250074

Name: FDA 510(k) clearance K250074
Creator: U.S. Food and Drug Administration
Published: 2026-04-03

Substantially Equivalent

Hyalex Orthopaedics, Inc.

FDA 510(k) clearance K250074 for HYALEX® MTP Hemiarthroplasty Implant, Substantially Equivalent on 2026-04-03. Applicant: Hyalex Orthopaedics, Inc.. Device class: 2.

Summary

Hyalex Orthopaedics' HYALEX MTP Hemiarthroplasty Implant is filed under product code KWD (Prosthesis, Toe, Hemi-, Phalangeal).

Class II, 21 CFR 888.3730. Orthopedic is both the classification panel and the review panel. It came in as a Traditional 510(k).

Hyalex Orthopaedics filed from Lexington, Massachusetts. The record shows 448 calendar days from receipt to decision (January 10, 2025 to April 3, 2026).

Clearance details

Applicant: Hyalex Orthopaedics, Inc.
Product code: Product code KWD
Device class: Class 2
Regulation: 21 CFR 888.3730
Advisory panel: Orthopedic
Date received: 2025-01-10
Decision date: 2026-04-03
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Lexington, MA, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code KWD

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K240268 — Accu-Joint Hemi Implant2024-02-29
K221220 — Montross Extremity Medical Hemi Implant System2023-04-19
K222964 — BioPoly Lesser Toe Hemiarthroplasty Implant2022-11-22
K201393 — restor3d MTP Implant2022-05-25
K203634 — BioPoly Great Toe Hemiarthroplasty Implant2021-02-02

Adverse events under product code KWD

product code KWD

Injury: 164
Total: 164

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.