HYALEX® MTP Hemiarthroplasty Implant

FDA 510(k) K250074 · Hyalex Orthopaedics, Inc.

Substantially Equivalent

510(k) numberK250074

Submission

Device name
HYALEX® MTP Hemiarthroplasty Implant
Applicant
Hyalex Orthopaedics, Inc.
Lexington, MA, US
Received
January 10, 2025
Decision date
April 3, 2026
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)
Summary
510(k) summary available from FDA

Official FDA 510(k) record

Device classification

Product code
KWD – Prosthesis, Toe, Hemi-, Phalangeal
Device class
Class II (moderate risk)
Regulation
21 CFR 888.3730
Specialty
Orthopedic
Implant
Yes

Other 510(k)s with product code KWD

510(k)DeviceApplicantDecision
K240268Accu-Joint Hemi ImplantKWD · Special Accufix Surgical, Inc.02/29/2024SE
K221220Montross Extremity Medical Hemi Implant SystemKWD · Traditional Montross Extremity Medical04/19/2023SE
K222964BioPoly Lesser Toe Hemiarthroplasty ImplantKWD · Traditional BioPoly, LLC11/22/2022SE
K201393restor3d MTP ImplantKWD · Traditional Restor3D, Inc.05/25/2022SE
K203634BioPoly Great Toe Hemiarthroplasty ImplantKWD · Traditional BioPoly, LLC02/02/2021SE
K200951Accu-Joint Hemi ImplantKWD · Traditional Accufix Surgical, Inc.12/08/2020SE
K190261BOSS Toe Fixation SystemKWD · Traditional Arthrosurface, Inc.08/14/2019SE
K190543Cannulated Hemi ImplantKWD · Traditional Vilex IN Tennessee, Inc.05/31/2019SE
K161279Life Spine Metatarsal Hemi ImplantKWD · Traditional Life Spine, Inc.02/01/2017SE
K152454HemiCAP MTP Resurfacing Hemi-Arthroplasty SystemKWD · Special Arthrosurface, Inc.04/11/2016SE

Questions and answers

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

HYALEX® MTP Hemiarthroplasty Implant (K250074) received a 510(k) decision of Substantially Equivalent on April 3, 2026, 448 days after the submission was received.

What is the product code of K250074?

The FDA product code is KWD – Prosthesis, Toe, Hemi-, Phalangeal, a Class II (moderate risk) device regulated under 21 CFR 888.3730.