510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K250074Substantially Equivalent

HYALEX® MTP Hemiarthroplasty Implant

Hyalex Orthopaedics, Lexington MA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K250074 is the FDA 510(k) clearance record for HYALEX® MTP Hemiarthroplasty Implant, a class II device, cleared for Hyalex Orthopaedics, Inc. on under FDA product code KWD (Prosthesis, Toe, Hemi-, Phalangeal). FDA records list one 510(k) clearance for Hyalex Orthopaedics, Inc. As of , FDA records show no recalls naming K250074.

Clearance record

Decision date
Received
(448 days to decision)
Product code
KWD Prosthesis, Toe, Hemi-, Phalangeal
Regulation
21 CFR 888.3730
Device class
Class II
Review panel
Orthopedic
Applicant
Hyalex Orthopaedics, Inc. 99 Hayden Ave., Lexington MA
510(k) summary
Summary PDF
Third party review
No

Clearances, product code KWD

Trailing 12 months
1 clearance under product code KWD in the twelve months to October 2026, April 2026 the highest month at 1.
Show the numbers
Monthly 510(k) clearances under FDA product code KWD, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20260
March 20260
April 20261
May 20260
June 20260
July 20260
August 20260
September 20260
October 20260