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Elucid raises $55M Series D with FFR-CT 510(k) under FDA review Enovis to buy eCential Robotics for 155 million euros FDA authorizes Vitestro's Aletta, the first autonomous blood-drawing robot, five months after a $70M Series B Renata Medical raises $25M Series D to scale the Minima pediatric stent FDA opens a docket on how to regulate generative AI devices FDA clears Jupiter Endovascular's Vertex thrombectomy system for pulmonary embolism in 89 days FDA clears Wandercraft's Eve, the first self-balancing exoskeleton for home use Meduloc raises $4M Series B to start alpha launch of its nitinol fracture implant FDA sets FY2027 device user fees: $28,653 for a 510(k), $13,785 to register Elucid raises $55M Series D with FFR-CT 510(k) under FDA review Enovis to buy eCential Robotics for 155 million euros FDA authorizes Vitestro's Aletta, the first autonomous blood-drawing robot, five months after a $70M Series B Renata Medical raises $25M Series D to scale the Minima pediatric stent FDA opens a docket on how to regulate generative AI devices FDA clears Jupiter Endovascular's Vertex thrombectomy system for pulmonary embolism in 89 days FDA clears Wandercraft's Eve, the first self-balancing exoskeleton for home use Meduloc raises $4M Series B to start alpha launch of its nitinol fracture implant FDA sets FY2027 device user fees: $28,653 for a 510(k), $13,785 to register

The Tracker / April 2026 / K250074

510(k) cleared

HYALEX® MTP Hemiarthroplasty Implant

Hyalex Orthopaedics, Inc. · Apr 3, 2026 · K250074

FDA cleared the HYALEX® MTP Hemiarthroplasty Implant from Hyalex Orthopaedics, Inc. on Apr 3, 2026 under K250074, a traditional 510(k). The device falls under product code KWD, Prosthesis, Toe, Hemi-, Phalangeal, regulated at 21 CFR 888.3730 as a Class 2 device. The review panel was Orthopedic.

FDA logged the submission as received on Jan 10, 2025. The decision came 448 days later, longer than the 90 FDA-day review goal, which usually means at least one additional information request.

This is the only decision on file for Hyalex Orthopaedics, Inc. in the last 12 months of the tracker.

Questions & Answers

What did FDA clear under K250074?

K250074 is the FDA 510(k) for HYALEX® MTP Hemiarthroplasty Implant, submitted by Hyalex Orthopaedics, Inc.. FDA's decision date was Apr 3, 2026, under product code KWD (Prosthesis, Toe, Hemi-, Phalangeal).

Who makes the HYALEX® MTP Hemiarthroplasty Implant?

Hyalex Orthopaedics, Inc., based in Lexington, MA, is the applicant of record for K250074.

How long did the K250074 review take?

FDA received the submission on Jan 10, 2025 and issued its decision on Apr 3, 2026, 448 days later.

← All decisions in April 2026