510(k) K250074

HYALEX® MTP Hemiarthroplasty Implant by Hyalex Orthopaedics, Inc. — Product Code KWD

K250074 is an FDA 510(k) premarket notification submitted by Hyalex Orthopaedics, Inc. for the device "HYALEX® MTP Hemiarthroplasty Implant". The FDA issued a decision of Substantially Equivalent on April 3, 2026. The device falls under product code KWD (Prosthesis, Toe, Hemi-, Phalangeal), a Class II device regulated under 21 CFR 888.3730.