FDA 510(k)

HYALEX® MTP Hemiarthroplasty Implant

K-Number: K250074 · 2026-04-03

Decision Date2026-04-03

Product CodeKWD

Advisory CommitteeOR

DecisionSubstantially Equivalent

Device Summary

HYALEX® MTP Hemiarthroplasty Implant is a medical device manufactured by Hyalex Orthopaedics, Inc.. It received FDA 510(k) clearance on 2026-04-03 under approval 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. It is manufactured by Hyalex Orthopaedics, Inc.. The 510(k) number is K250074.

When was HYALEX® MTP Hemiarthroplasty Implant approved by the FDA?

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

What company makes HYALEX® MTP Hemiarthroplasty Implant?

HYALEX® MTP Hemiarthroplasty Implant is manufactured by Hyalex Orthopaedics, Inc..

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

NCT07538141 The Hyalex MTP Study RECRUITING NCT06368700 The HYALEX Pivotal Study RECRUITING

Related Devices (Code: KWD)

K152454HemiCAP MTP Resurfacing Hemi-Arthroplasty SystemArthrosurface, Inc. K161279Life Spine Metatarsal Hemi ImplantLife Spine, Inc. K190261BOSS Toe Fixation SystemArthrosurface, Inc. K190543Cannulated Hemi ImplantVilex IN Tennessee, Inc. K200951Accu-Joint Hemi ImplantAccufix Surgical, Inc. K203634BioPoly Great Toe Hemiarthroplasty ImplantBioPoly, LLC

Official Source

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