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FDA 510(k)

HYALEX® MTP Hemiarthroplasty Implant

K-Number: K250074 · 2026-04-03

ApplicantHyalex Orthopaedics, Inc.
Decision Date2026-04-03
Product CodeKWD
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

HYALEX® MTP Hemiarthroplasty Implant is the device name listed in this FDA 510(k) record. The listed applicant is Hyalex Orthopaedics, Inc.. It received FDA 510(k) clearance on 2026-04-03 under 510(k) number K250074. The device is classified under product code KWD. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the HYALEX® MTP Hemiarthroplasty Implant?

HYALEX® MTP Hemiarthroplasty Implant is a medical device that received FDA 510(k) clearance on 2026-04-03. The listed applicant is Hyalex Orthopaedics, Inc.. The 510(k) number is K250074.

When did HYALEX® MTP Hemiarthroplasty Implant receive FDA 510(k) clearance?

HYALEX® MTP Hemiarthroplasty Implant received FDA 510(k) clearance on 2026-04-03, under 510(k) number K250074.

Who is the listed applicant for HYALEX® MTP Hemiarthroplasty Implant?

The FDA 510(k) record lists Hyalex Orthopaedics, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for HYALEX® MTP Hemiarthroplasty Implant?

The FDA product code for HYALEX® MTP Hemiarthroplasty Implant is KWD.

Related Clinical Trials

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

NCT07538141The Hyalex MTP StudyRECRUITING

Related Devices (Code: KWD)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K240268Accu-Joint Hemi ImplantAccufix Surgical, Inc.K221220Montross Extremity Medical Hemi Implant SystemMontross Extremity MedicalK222964BioPoly Lesser Toe Hemiarthroplasty ImplantBioPoly, LLCK201393restor3d MTP ImplantRestor3D, Inc.K203634BioPoly Great Toe Hemiarthroplasty ImplantBioPoly, LLCK200951Accu-Joint Hemi ImplantAccufix Surgical, Inc.

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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