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K Number
K250074

Validate with FDA (Live)

Device Name
HYALEX® MTP Hemiarthroplasty Implant
Manufacturer
Hyalex Orthopaedics, Inc.
Date Cleared
2026-04-03

(448 days)

Product Code
KWD
Regulation Number
888.3730
Type
Traditional
Panel
Orthopedic
Age Range
N/A
Reference & Predicate Devices
N/A
Predicate For
N/A
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticPediatricDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use
Device Description
AI/ML Overview

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§ 888.3730 Toe joint phalangeal (hemi-toe) polymer prosthesis.

(a)
Identification. A toe joint phalangeal (hemi-toe) polymer prosthesis is a device made of silicone elastomer intended to be implanted to replace the base of the proximal phalanx of the toe.(b)
Classification. Class II.