510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
Medical Device
ManufacturingTHE TRADE PAPER OF THE FACTORY FLOOR
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K102401Substantially Equivalent

Hemi Implant; Mini Hemi Implant

Vilex LLC, Mcminnville TN / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K102401 is the FDA 510(k) clearance record for HEMI IMPLANT; MINI HEMI IMPLANT, a class II device, cleared for Vilex, Inc. on under FDA product code KWD (Prosthesis, Toe, Hemi-, Phalangeal). FDA records list 27 510(k) clearances for Vilex, Inc., from to . As of , FDA records show no recalls naming K102401.

Clearance record

Decision date
Received
(330 days to decision)
Product code
KWD Prosthesis, Toe, Hemi-, Phalangeal
Regulation
21 CFR 888.3730
Device class
Class II
Review panel
Orthopedic
Applicant
Vilex, Inc. 111 Moffitt St., Mcminnville TN
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